Studie zkoumající účinnost a bezpečnost OG-6219 BID ve 3 úrovních dávky ve srovnání s placebem u účastníků ve věku 18 až 49 let se středně těžkou až těžkou bolestí související s endometriózou (ELENA)
16. dubna 2026 aktualizováno: Organon and Co
Fáze 2a/b, randomizovaná, dvojitě zaslepená, placebem kontrolovaná, paralelní skupina, multicentrická, klinická studie k vyhodnocení účinnosti a bezpečnosti OG-6219 ve 3 úrovních dávek, u žen ve věku 18 až 49 let se střední až těžkou Bolest související s endometriózou
Účelem této globální studie fáze 2 je určit účinnost, bezpečnost a snášenlivost 3 dávek OG-6219 u premenopauzálních žen ve věku 18 až 49 let (včetně), které mají středně těžkou až těžkou endometriózu bolest.
Přehled studie
Detailní popis
Toto je globální multicentrická, fáze 2a/b, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie k posouzení účinnosti, bezpečnosti a snášenlivosti 3 úrovní dávek OG-6219 u premenopauzálních žen ve věku 18 až 49 let. (včetně), kterým byla chirurgicky diagnostikována endometrióza se středně těžkou až těžkou bolestí související s endometriózou. Tato studie zahrnuje léčbu trvající celkem přibližně 16 týdnů a po ní následuje bezpečnostní sledování.
Ženy před menopauzou ve věku 18 až 49 let (včetně), u kterých byla chirurgicky diagnostikována endometrióza, budou podrobeny screeningu, aby byly náhodně přiřazeny ke studijní léčbě. Minimální podskupina 10 účastníků na léčebnou skupinu (včetně skupiny s placebem) bude dobrovolně zařazena do volitelného intenzivního odběru vzorků PK po celou dobu trvání studie.
Typ studie
Intervenční
Zápis (Aktuální)
354
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Brussels, Belgie, 1200
- Cliniques Universitaires Saint-Luc
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Ghent, Belgie, 9000
- Universitair Ziekenhuis Ghent
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Ghent, Belgie, 9000
- AZ Jan Palfijn Gent
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Hasselt, Belgie, 3500
- Jessa Ziekenhuis Hospital
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La Louvière, Belgie, 7100
- CHU de Tivoli
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Pleven, Bulharsko, 5800
- Medical Center Repromed EOOD
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Plovdiv, Bulharsko, 4002
- UMHAT "Sv. Georgi", EAD
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Sofia, Bulharsko, 1510
- Medical Center Hera EOOD
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Sofia, Bulharsko, 1233
- SHATOD - Sofia District, EOOD
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Sofia, Bulharsko, 1431
- DCC "Alexandrovska", EOOD
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Sofia, Bulharsko, 1330
- MHAT for women's health - Nadezhda, OOD
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Sofia, Bulharsko, 1202
- DCC " Ascendent" EAD
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Sofia, Bulharsko, 1606
- Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD
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Stara Zagora, Bulharsko, 6000
- MHAT NiaMed OOD
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Varna, Bulharsko, 9002
- Acibadem City Clinic MC Varna EOOD
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Paris, Francie, 75020
- Hopital Tenon
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Paris, Francie, 75014
- Hôpital Cochin
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Strasbourg, Francie, 67200
- Hospital of Hautepierre
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Paris
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Paris, Paris, Francie, 75674
- Hôpital Saint Joseph Paris
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Monserrato, Itálie, 09042
- Università di Cagliari-Presidio Policlinico Monserrato
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Siena, Itálie, 53100
- University of Siena Policlinico
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Verona, Itálie, 37134
- Centro Ricerche Cliniche di Verona S.r.l.
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Milano
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Seriate, Milano, Itálie, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Roma
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Rome, Roma, Itálie, 168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Riga, Lotyšsko, LV-1005
- Latvian Maritime Medical Centre
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Riga, Lotyšsko, LV-1006
- Vitols & Vitols, Ltd.
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Riga, Lotyšsko, LV-1011
- Dr. Vasaraudze's Private Clinic
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Budapest, Maďarsko, 1033
- Clinexpert Kft.
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Budapest, Maďarsko, 1082
- Semmelweis Egyetem
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Debrecen, Maďarsko, 4024
- Szent Anna Maganrendelo
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Kaposvár, Maďarsko, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Nyíregyháza, Maďarsko, 4400
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
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Berlin, Německo, 13353
- Charite - Campus Benjamin Franklin
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Homburg, Německo, D-66421
- Universitätsklinikum des Saarlandes
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Německo, 40225
- Universitaetsklinikum Duesseldorf AoeR
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Bialystok, Polsko, 15-224
- Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa
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Bialystok, Polsko, 15-267
- Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
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Katowice, Polsko, 40-156
- Clinical Medical Research Sp. z o.o.
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Katowice, Polsko, 40-081
- Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
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Katowice, Polsko, 40-301
- NZOZ Medem
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Lodz, Polsko, 91-053
- Centra Medyczne Medyceusz
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Lublin, Polsko, 20-362
- KO-MED Centra Kliniczne Lublin II
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Lublin, Polsko, 20-064
- Specjalistyczny Gabinet Ginekologiczno-Położniczy
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Lublin, Polsko, 20-093
- Centrum Medyczne Chodzki HLK
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Olsztyn, Polsko, 10-117
- Etyka Osrodek Badan Klinicznych
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Siedlce, Polsko, 08-110
- ETG Siedlce
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Szczecin, Polsko, 70-225
- Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
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Torun, Polsko, 87-100
- MICS Centrum Medyczne Torun
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Warsaw, Polsko, 02-172
- PRATIA S.A. MTZ Clinical Research Powered by Pratia
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Warsaw, Polsko, 00-144
- Specjalistyczna Praktyka Lekar
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Warsaw, Polsko, 04-141
- WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON
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Dolnoslask
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Wroclaw, Dolnoslask, Polsko, 54-034
- Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.
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Alabama
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Birmingham, Alabama, Spojené státy, 35205
- Central Research Associates LLC dba Flourish Research
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Birmingham, Alabama, Spojené státy, 35233
- UAB Center for Women's Reproductive Health
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California
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Los Angeles, California, Spojené státy, 90036
- Olympia Clinical Trials
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Connecticut
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Orange, Connecticut, Spojené státy, 06477
- Yale Fertility Center
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Florida
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Sarasota, Florida, Spojené státy, 34239
- Physician Care Clinical Research, LLC
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Tampa, Florida, Spojené státy, 33606
- University of South Florida
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Georgia
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Atlanta, Georgia, Spojené státy, 30363
- MediSense Inc
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College Park, Georgia, Spojené státy, 30349
- Paramount Research Solutions
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Morrow, Georgia, Spojené státy, 30260
- Infinite Clinical Trials
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Illinois
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Park Ridge, Illinois, Spojené státy, 60068
- The Advanced Gynecologic Surgery Institute
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70115
- Ochsner Health Center - Baptist McFarland Medical Plaza
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Shreveport, Louisiana, Spojené státy, 71118
- Omni Fertility and Laser Institute
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Maryland
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Baltimore, Maryland, Spojené státy, 21205
- John Hopkins University
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87109
- Bosque Women's Care
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Ohio
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Cincinnati, Ohio, Spojené státy, 45267-0502
- University of Cincinnati
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Dublin, Ohio, Spojené státy, 43016
- Centricity Research Dublin
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Pennsylvania
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Hershey, Pennsylvania, Spojené státy, 17033
- Penn State Health Women's Health Clinic
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Philadelphia, Pennsylvania, Spojené státy, 19114
- Clinical Research Of Philadelphia, Llc
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South Carolina
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Summerville, South Carolina, Spojené státy, 29485
- Palmetto Clinical Research
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37404
- Chattanooga Medical Research, Llc
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Texas
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Euless, Texas, Spojené státy, 76040
- Cedar Health Research, LLC
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Houston, Texas, Spojené státy, 77074
- Clinical Trial Network LLC
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Houston, Texas, Spojené státy, 77024
- The Women's Hospital of Texas
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San Antonio, Texas, Spojené státy, 78233
- Northeast Clinical Research of San Antonio
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Utah
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Salt Lake City, Utah, Spojené státy, 84107
- Wasatch Clinical Research
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Virginia
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Norfolk, Virginia, Spojené státy, 23502
- Tidewater Clinical Research
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Washington
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Seattle, Washington, Spojené státy, 98105
- Seattle Women's: Health, Research, Gynecology
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Brno, Česko, 602 00
- Fakultni Nemocnice Brno
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Olomouc, Česko, 77900
- Fertimed s.r.o.
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Prague, Česko, 100 34
- Fakultní Nemocnice Královské Vinohrady
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Prague, Česko, 147 10
- Ustav pro peci o matku a dite
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Prague, Česko, 130 00
- Femina Sana s.r.o.
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Stockholm, Švédsko, 17176
- Karolinska University Hospital
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Stockholm, Švédsko, 182 88
- Danderyd Sjukhus
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 49 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Ženy před menopauzou ve věku 18 až 49 let (včetně) v době podpisu informovaného souhlasu (V1).
- Chirurgicky (laparoskopie nebo laparotomie) diagnostikována endometrióza
- Středně těžká až těžká pánevní bolest související s endometriózou
- Pravidelné menstruační cykly
- Neočekává se, že během účasti ve studii podstoupí plánovanou gynekologickou operaci nebo jiné chirurgické zákroky pro léčbu endometriózy.
- Normální vyšetření prsu na V1
- Souhlasíte s tím, že se během účasti na této studii nebudete účastnit jiné intervenční studie.
- Schopný a ochotný dodržovat studijní postupy vč
- souhlasit s používáním 2 forem nehormonální antikoncepce po celou dobu studie
- Musí být ochoten a schopen poskytnout podepsaný informovaný souhlas před jakoukoli činností související se studií
- Prokázal soulad s ≥75 % záznamů eDiary
- Má negativní těhotenský test
Kritéria vyloučení:
- Chirurgická anamnéza hysterektomie a/nebo bilaterální ooforektomie
- Chronická pánevní a/nebo mimopánevní bolest nezpůsobená endometriózou, která vyžaduje chronickou analgetickou nebo jinou chronickou léčbu
- Nediagnostikované (nevysvětlené), abnormální vaginální krvácení nesouvisející s endometriózou během posledních 6 měsíců před screeningem.
- Přítomnost vysoce rizikového lidského papilomaviru (HPV).
- Má aktivní sexuálně přenosnou infekci (STI) (např. kapavku, chlamydie nebo trichomonas).
- Hodlá otěhotnět nebo kojit během účasti ve studii nebo má známou nebo předpokládanou graviditu.
- Malignita v anamnéze ≤ 5 let s výjimkou adekvátně léčené bazocelulární nebo spinocelulární rakoviny kůže nebo in situ rakoviny děložního čípku.
- Rodinná anamnéza dědičného abnormálního hemoglobinu nebo deficitu enzymu, který může vést k methemoglobinémii.
- Má zdravotní stav spojený s hemolytickou anémií
- Známá infekce virem lidské imunodeficience s aktivní, rekurentní nebo chronickou infekcí (např. virus hepatitidy A, B nebo C)
- Má klinicky významné abnormální EKG nebo prodloužení QT intervalu
- Užil jakýkoli lék, který je citlivým substrátem, středně silným nebo silným inhibitorem nebo induktorem CYP3A4 během 30 dnů nebo 10 poločasů (podle toho, co je delší) před plánovaným prvním dnem podávání.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Skupina A: OG-6219 Dávka 1
Skupina A: OG-6219 Dávka 1 BID
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OG-6219 Dávka 1, Dávka 2, Dávka 3 BID: Účastníci dostanou (perorálně) tablety OG-6219 během léčebných cyklů.
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Experimentální: Skupina B: OG-6219 Dávka 2
Skupina B: OG-6219 Dávka 2 BID
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OG-6219 Dávka 1, Dávka 2, Dávka 3 BID: Účastníci dostanou (perorálně) tablety OG-6219 během léčebných cyklů.
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Experimentální: Skupina C: OG-6219 Dávka 3
Skupina C: OG-6219 Dávka 3 BID
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OG-6219 Dávka 1, Dávka 2, Dávka 3 BID: Účastníci dostanou (perorálně) tablety OG-6219 během léčebných cyklů.
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Komparátor placeba: Skupina D: Placebo
Skupina D: Placebo BID
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Účastníci obdrží (ústně) tablety OG-6219 Placebo BID během léčebných cyklů.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Časové okno: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea or NMPP, and dyspareunia.
Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome.
The mean OPP score was derived by the pain score for the dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome.
Baseline cycle OPP score was defined as the average daily OPP during baseline cycle.
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Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Časové okno: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
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An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment.
An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration.
Percentages are rounded off to the hundredth decimal place.
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From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
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Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
Časové okno: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
|
An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment.
TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration.
The TEAEs leading to permanent discontinuation of study drug was identified by using the 'Action taken with study treatment' variable equal to 'Drug withdrawal' from the AE page of the electronic case report form.
Percentages are rounded off to the hundredth decimal place.
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From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Časové okno: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
|
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea.
Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome.
The mean dysmenorrhea score was calculated for each cycle as the total of daily dysmenorrhea scores reported during the cycle divided by the number of days during the cycle when a dysmenorrhea score was reported.
Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
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Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Change From Baseline Cycle in Mean Non-Menstrual Pelvic Pain Score at Treatment Cycle 3
Časové okno: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
|
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea.
Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome.
The mean NMPP score was calculated for each cycle as the total of daily NMPP scores reported during the cycle divided by the number of days during the cycle when a NMPP score was reported.
Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
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Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
|
|
Change From Baseline Cycle in Mean Dyspareunia Score at Treatment Cycle 3
Časové okno: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
|
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dyspareunia.
Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome.
The mean dyspareunia score was calculated for each cycle as the total of dyspareunia scores reported during each cycle divided by the number of days when participants engaged in any sexual activity that involved full vaginal penetration during each cycle (that is, the number of days during the baseline cycle when a dyspareunia score was reported).
Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
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Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Change From Baseline Cycle in Mean Number of Rescue Medication Tablets Used for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3
Časové okno: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
|
Participants were asked daily whether they used the rescue medication in the past 24 hours to treat their ERP.
If yes, the number of tablets was documented.
The mean number of tablets of rescue medication for ERP was calculated for each cycle as the total number of tablets of rescue medication for ERP reported during the cycle, divided by the number of days during the cycle when a value was reported.
Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
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Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Change From Baseline Cycle in Percentage of Days With Participants Used Rescue Medication for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3
Časové okno: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
|
Participants were asked daily whether they used the rescue medication in the past 24 hours to treat their ERP.
If yes, the number of tablets was documented.
The percentage of days participant had used rescue medication for ERP was calculated for each cycle as the total number of days participant had used any rescue medication for ERP, divided by the number of days during the cycle when a value was reported.
Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
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Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Change From Start of Treatment Cycle 1 in Participants With Patient Global Impression of Severity (PGI-S) to Start of Treatment Cycle 2, End of Treatment Cycles 2 and 3
Časové okno: Start of Treatment Cycle 1 (Day 1) and start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
|
The PGI-S was a single item measuring the overall severity of pelvic pain over the past 7 days on a 4-point Likert-type scale (0=None, 1=Mild, 2=Moderate, 3=Severe), score ranged from 0 (none) and 3 (severe), where lower score indicated a better outcome.
Treatment Cycle 1 was the period between the first day of menses associated with treatment start (Visit 4) to the day prior to the first day of next menses, regardless of number of days.
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Start of Treatment Cycle 1 (Day 1) and start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Percentage of Participants With Any Improvement on the Patient Global Impression of Change (PGI-C) at Start of Treatment Cycle 2 and End of Treatment Cycles 2 and 3
Časové okno: Start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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The PGI-C was a single item measuring the change in pelvic pain since the start of the study drug on a 5-point scale (0=much better, 1=a little better, 2=no change, 3=a little worse, 4=much worse), score ranged from 0 (much better) and 4 (much worse), where lower score indicated a better outcome.
Participants with any improvement on the PGI-C were defined as a PGI-C score of 0 or 1 (0=much better and 1=a little better).
Treatment Cycle 2 was the period between the first day of menses associated with start of treatment Cycle 2 to the day prior to the first day of next menses, regardless of number of days.
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Start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Change From Baseline Cycle in Endometriosis Health Profile-30 (EHP-30) Domains Score at Treatment Cycle 3
Časové okno: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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The EHP-30 was a validated disease specific patient-reported outcome instrument measuring the health-related quality of life of women with endometriosis on a 5-point Likert-type scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=always).
The EHP-30 consisted of 30 items with following domains: pain (11 items), score ranged from 0 (never) to 44 (always); controls and powerlessness (6 items), score ranged from 0 (never) to 24 (always); emotional well-being (6 items), score ranged from 0 (never) to 24 (always); social support (4 items), score ranged from 0 (never) to 16 (always); and self-image (3 items), score ranged from 0 (never) to 12 (always).
Each domain lower score indicated a better outcome.
Total EHP-30 score ranged from 0 (never) and 120 (always), where lower score indicated a better outcome.
Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
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Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Mean Change From Screening in C-Telopeptide of Type I Collagen (CTX) and Procollagen Type I N-Terminal Propeptide (P1NP) at End of Treatment Cycle 3
Časové okno: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Potential effects on bone was monitored by biomarkers of bone resorption and formation.
Bone resorption was determined by assessing CTX level and bone formation was determined by assessing P1NP level.
Screening (Visit 1) was defined as the last measurement before study drug administration.
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Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Mean Change From Screening in Bone-Specific Alkaline Phosphatase (BSAP) and Osteocalcin at End of Treatment Cycle 3
Časové okno: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Potential effects on bone was monitored by biomarkers of bone resorption and formation.
Bone formation was determined by assessing BSAP and osteocalcin level.
Screening (Visit 1) was defined as the last measurement before study drug administration.
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Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Mean Change From Screening in N-Telopeptide of Type I Collagen (NTX) at End of Treatment Cycle 3
Časové okno: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Potential effects on bone was monitored by biomarkers of bone resorption and formation.
Bone resorption was determined by assessing NTX level.
Screening (Visit 1) was defined as the last measurement before study drug administration.
nmol BCE/L= nanomoles of bone collagen equivalents per liter.
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Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Mean Change From Screening in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b) at End of Treatment Cycle 3
Časové okno: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Potential effects on bone was monitored by biomarkers of bone resorption and formation.
Bone resorption was determined by assessing TRAP5b level.
Screening (Visit 1) was defined as the last measurement before study drug administration.
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Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Number of Participants With Clinically Significant Laboratory Abnormalities
Časové okno: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
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Blood samples were collected to determine the clinical laboratory abnormalities.
The laboratory assessments included chemistry, hematology and urinalysis.
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From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
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Mean Change From Baseline Cycle in Sum of Days on Period at Treatment Cycles 1, 2 and 3
Časové okno: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Participants recorded the presence of bleeding or spotting daily in the eDiary.
The daily questions to assess bleeding pattern in the eDiary were "1a: During the past 24 hours, did you have any vaginal bleeding or spotting?
If the response is "Yes", then the next question is, "1b: During the past 24 hours, have you been on your period?".
Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
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Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Parameters Abnormalities
Časové okno: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
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Triplicate standard 12-lead ECGs was obtained after the participant was in supine position for at least 5 minutes.
The ECG measurements was summarized by taking the average of the available assessments.
Only clinically significant ECG abnormalities are reported.
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From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
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Mean Change From Screening in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Časové okno: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Blood samples were collected to determine the serum level of LH and FSH.
The LH surge was determined with urine LH kit at home.
Screening (Visit 1) was defined as the last measurement before study drug administration.
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Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Mean Change From Screening in Estrone (E1) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Časové okno: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Blood samples were collected to determine the serum level of E1.
The LH surge was determined with urine LH kit at home.
Screening (Visit 1) was defined as the last measurement before study drug administration.
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Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Mean Change From Screening in Progesterone, Testosterone and Dehydroepiandrosterone (DHEA) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Časové okno: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Blood samples were collected to determine the serum level of progesterone, testosterone and DHEA.
The LH surge was determined with urine LH kit at home.
Screening (Visit 1) was defined as the last measurement before study drug administration.
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Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Mean Change From Screening in Free Testosterone and Estradiol (E2) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Časové okno: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
|
Blood samples were collected to determine the serum level of free testosterone and E2.
The LH surge was determined with urine LH kit at home.
Screening (Visit 1) was defined as the last measurement before study drug administration.
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Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Mean Change From Screening in Dehydroepiandrosterone Sulfate (DHEAS) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Časové okno: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Blood samples were collected to determine the serum level of DHEAS.
The LH surge was determined with urine LH kit at home.
Screening (Visit 1) was defined as the last measurement before study drug administration.
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Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Plasma Concentrations of OG-6219 and FOR-1011
Časové okno: Pre-witness dose and 1.5 hours postdose on start of Treatment Cycle 1 (Day 1), at 7 days after urine LH surge, and end of Treatment Cycle 2; Pre-witness dose on end of Treatment Cycle 3
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Blood samples were collected to determine plasma concentration of OG-6219 and FOR-1011.
The plasma concentration of OG-6219 and FOR-1011 was analyzed using an appropriate validated bioanalytical method.
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Pre-witness dose and 1.5 hours postdose on start of Treatment Cycle 1 (Day 1), at 7 days after urine LH surge, and end of Treatment Cycle 2; Pre-witness dose on end of Treatment Cycle 3
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Maximum Concentration (Cmax) of OG-6219 and FOR-1011
Časové okno: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
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Blood samples were collected to determine Cmax of OG-6219 and FOR-1011.
The Cmax of OG-6219 and FOR-1011 was calculated using non-compartmental method.
NCA= Noncompartmental analysis.
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Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
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Time Taken to Reach the Maximum Concentration (Tmax) of OG-6219 and FOR-1011
Časové okno: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
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Blood samples were collected to determine tmax of OG-6219 and FOR-1011.
The tmax of OG-6219 and FOR-1011 was calculated using non-compartmental method.
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Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
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Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of OG-6219 and FOR-1011
Časové okno: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
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Blood samples were collected to determine AUCtau of OG-6219 and FOR-1011.
The AUCtau of OG-6219 and FOR-1011 was calculated using non-compartmental method.
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Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Clinical Lead Late-Stage Clinical Development, Organon and Co
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
25. října 2022
Primární dokončení (Aktuální)
28. května 2025
Dokončení studie (Aktuální)
28. května 2025
Termíny zápisu do studia
První předloženo
20. září 2022
První předloženo, které splnilo kritéria kontroly kvality
26. září 2022
První zveřejněno (Aktuální)
29. září 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. dubna 2026
Naposledy ověřeno
1. března 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- OG-6219-P001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .