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En undersøgelse til undersøgelse af effektivitet og sikkerhed af OG-6219 BID i 3 dosisniveauer sammenlignet med placebo hos deltagere i alderen 18 til 49 år med moderat til svær endometriose-relateret smerte (ELENA)

16. april 2026 opdateret af: Organon and Co

En fase 2a/b, randomiseret, dobbeltblind, placebokontrolleret, parallel gruppe, multicenter, klinisk undersøgelse for at evaluere effektiviteten og sikkerheden af ​​OG-6219 i 3 dosisniveauer, hos kvinder i alderen 18 til 49 år med moderat til svær Endometriose-relateret smerte

Formålet med dette globale fase 2-studie er at bestemme effektiviteten, sikkerheden og tolerabiliteten af ​​3 dosisniveauer af OG-6219 hos præmenopausale kvinder mellem 18 og 49 år (inklusive), som har moderat til svær endometriose-relateret smerte.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et globalt multicenter, fase 2a/b, randomiseret, dobbeltblindet, placebokontrolleret undersøgelse til vurdering af effektiviteten, sikkerheden og tolerabiliteten af ​​3 dosisniveauer af OG-6219 hos præmenopausale kvinder i alderen 18 til 49 år. (inklusive), som er blevet kirurgisk diagnosticeret med endometriose med moderat til svær endometriose-relaterede smerter. Denne undersøgelse omfatter behandling, der varer cirka 16 uger i alt og efterfølges af en sikkerhedsopfølgning.

Præmenopausale kvinder i alderen 18 til 49 år (inklusive), som er blevet kirurgisk diagnosticeret med endometriose, vil blive screenet for tilfældigt at tildele undersøgelsesbehandling. Et minimumsundersæt på 10 deltagere pr. behandlingsgruppe (inklusive placebogruppen) vil frivilligt blive tilmeldt til valgfri intensiv PK-prøvetagning i hele undersøgelsens varighed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

354

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Brussels, Belgien, 1200
        • Cliniques Universitaires Saint-Luc
      • Ghent, Belgien, 9000
        • Universitair Ziekenhuis Ghent
      • Ghent, Belgien, 9000
        • AZ Jan Palfijn Gent
      • Hasselt, Belgien, 3500
        • Jessa Ziekenhuis Hospital
      • La Louvière, Belgien, 7100
        • CHU de Tivoli
  • Bulgarien
      • Pleven, Bulgarien, 5800
        • Medical Center Repromed EOOD
      • Plovdiv, Bulgarien, 4002
        • UMHAT "Sv. Georgi", EAD
      • Sofia, Bulgarien, 1510
        • Medical Center Hera EOOD
      • Sofia, Bulgarien, 1233
        • SHATOD - Sofia District, EOOD
      • Sofia, Bulgarien, 1431
        • DCC "Alexandrovska", EOOD
      • Sofia, Bulgarien, 1330
        • MHAT for women's health - Nadezhda, OOD
      • Sofia, Bulgarien, 1202
        • DCC " Ascendent" EAD
      • Sofia, Bulgarien, 1606
        • Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD
      • Stara Zagora, Bulgarien, 6000
        • MHAT NiaMed OOD
      • Varna, Bulgarien, 9002
        • Acibadem City Clinic MC Varna EOOD
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Central Research Associates LLC dba Flourish Research
      • Birmingham, Alabama, Forenede Stater, 35233
        • UAB Center for Women's Reproductive Health
    • California
      • Los Angeles, California, Forenede Stater, 90036
        • Olympia Clinical Trials
    • Connecticut
      • Orange, Connecticut, Forenede Stater, 06477
        • Yale Fertility Center
    • Florida
      • Sarasota, Florida, Forenede Stater, 34239
        • Physician Care Clinical Research, LLC
      • Tampa, Florida, Forenede Stater, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30363
        • MediSense Inc
      • College Park, Georgia, Forenede Stater, 30349
        • Paramount Research Solutions
      • Morrow, Georgia, Forenede Stater, 30260
        • Infinite Clinical Trials
    • Illinois
      • Park Ridge, Illinois, Forenede Stater, 60068
        • The Advanced Gynecologic Surgery Institute
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Ochsner Health Center - Baptist McFarland Medical Plaza
      • Shreveport, Louisiana, Forenede Stater, 71118
        • Omni Fertility and Laser Institute
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • John Hopkins University
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • Bosque Women's Care
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267-0502
        • University of Cincinnati
      • Dublin, Ohio, Forenede Stater, 43016
        • Centricity Research Dublin
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Health Women's Health Clinic
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Clinical Research Of Philadelphia, Llc
    • South Carolina
      • Summerville, South Carolina, Forenede Stater, 29485
        • Palmetto Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Chattanooga Medical Research, Llc
    • Texas
      • Euless, Texas, Forenede Stater, 76040
        • Cedar Health Research, LLC
      • Houston, Texas, Forenede Stater, 77074
        • Clinical Trial Network LLC
      • Houston, Texas, Forenede Stater, 77024
        • The Women's Hospital of Texas
      • San Antonio, Texas, Forenede Stater, 78233
        • Northeast Clinical Research of San Antonio
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Wasatch Clinical Research
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Tidewater Clinical Research
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Seattle Women's: Health, Research, Gynecology
  • Frankrig
      • Paris, Frankrig, 75020
        • Hopital Tenon
      • Paris, Frankrig, 75014
        • Hôpital Cochin
      • Strasbourg, Frankrig, 67200
        • Hospital of Hautepierre
    • Paris
      • Paris, Paris, Frankrig, 75674
        • Hôpital Saint Joseph Paris
  • Italien
      • Monserrato, Italien, 09042
        • Università di Cagliari-Presidio Policlinico Monserrato
      • Siena, Italien, 53100
        • University of Siena Policlinico
      • Verona, Italien, 37134
        • Centro Ricerche Cliniche di Verona s.r.l.
    • Milano
      • Seriate, Milano, Italien, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    • Roma
      • Rome, Roma, Italien, 168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Letland
      • Riga, Letland, LV-1005
        • Latvian Maritime Medical Centre
      • Riga, Letland, LV-1006
        • Vitols & Vitols, Ltd.
      • Riga, Letland, LV-1011
        • Dr. Vasaraudze's Private Clinic
  • Polen
      • Bialystok, Polen, 15-224
        • Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa
      • Bialystok, Polen, 15-267
        • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
      • Katowice, Polen, 40-156
        • Clinical Medical Research Sp. z o.o.
      • Katowice, Polen, 40-081
        • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
      • Katowice, Polen, 40-301
        • NZOZ Medem
      • Lodz, Polen, 91-053
        • Centra Medyczne Medyceusz
      • Lublin, Polen, 20-362
        • KO-MED Centra Kliniczne Lublin II
      • Lublin, Polen, 20-064
        • Specjalistyczny Gabinet Ginekologiczno-Położniczy
      • Lublin, Polen, 20-093
        • Centrum Medyczne Chodzki HLK
      • Olsztyn, Polen, 10-117
        • Etyka Osrodek Badan Klinicznych
      • Siedlce, Polen, 08-110
        • ETG Siedlce
      • Szczecin, Polen, 70-225
        • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
      • Torun, Polen, 87-100
        • MICS Centrum Medyczne Torun
      • Warsaw, Polen, 02-172
        • PRATIA S.A. MTZ Clinical Research Powered by Pratia
      • Warsaw, Polen, 00-144
        • Specjalistyczna Praktyka Lekar
      • Warsaw, Polen, 04-141
        • WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON
    • Dolnoslask
      • Wroclaw, Dolnoslask, Polen, 54-034
        • Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.
  • Sverige
      • Stockholm, Sverige, 17176
        • Karolinska University Hospital
      • Stockholm, Sverige, 182 88
        • Danderyd Sjukhus
  • Tjekkiet
      • Brno, Tjekkiet, 602 00
        • Fakultni Nemocnice Brno
      • Olomouc, Tjekkiet, 77900
        • Fertimed s.r.o.
      • Prague, Tjekkiet, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Tjekkiet, 147 10
        • Ustav pro peci o matku a dite
      • Prague, Tjekkiet, 130 00
        • Femina Sana s.r.o.
  • Tyskland
      • Berlin, Tyskland, 13353
        • Charite - Campus Benjamin Franklin
      • Homburg, Tyskland, D-66421
        • Universitätsklinikum des Saarlandes
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Tyskland, 40225
        • Universitaetsklinikum Duesseldorf AoeR
  • Ungarn
      • Budapest, Ungarn, 1033
        • Clinexpert Kft.
      • Budapest, Ungarn, 1082
        • Semmelweis Egyetem
      • Debrecen, Ungarn, 4024
        • Szent Anna Maganrendelo
      • Kaposvár, Ungarn, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • Nyíregyháza, Ungarn, 4400
        • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 49 år (Voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Præmenopausale kvinder i alderen 18 til 49 år (inklusive) på tidspunktet for underskrivelse af informeret samtykke (V1).
  • Kirurgisk (laparoskopi eller laparotomi) diagnosticeret med endometriose
  • Moderat til svær endometriose-relaterede bækkensmerter
  • Regelmæssige menstruationscyklusser
  • Forventes ikke at gennemgå en planlagt gynækologisk operation eller andre kirurgiske indgreb til behandling af endometriose under studiedeltagelse.
  • Normal brystundersøgelse ved V1
  • Accepter ikke at deltage i en anden interventionsundersøgelse, mens du deltager i denne undersøgelse.
  • Kan og har lyst til at overholde studieprocedurer, herunder
  • accepterer at bruge 2 former for ikke-hormonel prævention gennem hele undersøgelsen
  • Skal være villig og i stand til at give underskrevet informeret samtykke før eventuelle undersøgelsesrelaterede aktiviteter
  • Har demonstreret overensstemmelse med ≥75 % af e-dagbogsposter
  • Har en negativ graviditetstest

Ekskluderingskriterier:

  • Kirurgisk anamnese med hysterektomi og/eller bilateral oophorektomi
  • Kroniske bækkensmerter og/eller ikke-bækkensmerter, der ikke er forårsaget af endometriose, der kræver kronisk smertestillende eller anden kronisk behandling
  • Udiagnosticeret (uforklaret), unormal vaginal blødning, der ikke er forbundet med endometriose inden for de seneste 6 måneder før screening.
  • Tilstedeværelse af højrisiko humant papillomavirus (HPV).
  • Har en aktiv seksuelt overført infektion (STI) (f.eks. gonoré, klamydia eller trichomonas).
  • Har til hensigt at blive gravid eller amme under studiedeltagelsen eller har en kendt eller mistænkt graviditet.
  • Anamnese med malignitet ≤5 år med undtagelse af tilstrækkeligt behandlet basalcelle- eller pladecellehudkræft eller in situ livmoderhalskræft.
  • Familiehistorie med arvelig unormal hæmoglobin eller en enzymmangel, der kan resultere i methæmoglobinæmi.
  • Har en medicinsk tilstand forbundet med hæmolytisk anæmi
  • Kendt human immundefektvirusinfektion med aktiv, tilbagevendende eller kronisk infektion (f.eks. hepatitis A-, B- eller C-virus)
  • Har en klinisk signifikant unormal EKG- eller QT-intervalforlængelse
  • Brugte en hvilken som helst medicin, der enten er et følsomt substrat, moderat eller stærk hæmmer eller inducerer af CYP3A4 inden for 30 dage eller 10 halveringstider (alt efter hvad der er længst) før den planlagte første doseringsdag.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gruppe A: OG-6219 Dosis 1
Gruppe A: OG-6219 Dosis 1 BID
Medicin: OG-6219
OG-6219 Dosis 1, Dosis 2, Dosis 3 BID: Deltagerne vil modtage (oralt) OG-6219 tabletter under behandlingscyklusser.
Eksperimentel: Gruppe B: OG-6219 Dosis 2
Gruppe B: OG-6219 Dosis 2 BID
Medicin: OG-6219
OG-6219 Dosis 1, Dosis 2, Dosis 3 BID: Deltagerne vil modtage (oralt) OG-6219 tabletter under behandlingscyklusser.
Eksperimentel: Gruppe C: OG-6219 Dosis 3
Gruppe C: OG-6219 Dosis 3 BID
Medicin: OG-6219
OG-6219 Dosis 1, Dosis 2, Dosis 3 BID: Deltagerne vil modtage (oralt) OG-6219 tabletter under behandlingscyklusser.
Placebo komparator: Gruppe D: Placebo
Gruppe D: Placebo BID
Medicin: Placebo
Deltagerne vil modtage (oralt) OG-6219 Placebo-tabletter BID under behandlingscyklusser.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Tidsramme: 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 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.
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).
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tidsramme: 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 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.
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
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
Tidsramme: 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.
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Tidsramme: 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.
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 Non-Menstrual Pelvic Pain Score at Treatment Cycle 3
Tidsramme: 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.
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
Tidsramme: 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.
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 Number of Rescue Medication Tablets Used for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3
Tidsramme: 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.
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).
Change From Baseline Cycle in Percentage of Days With Participants Used Rescue Medication for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3
Tidsramme: 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.
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).
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
Tidsramme: 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.
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).
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
Tidsramme: 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-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.
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).
Change From Baseline Cycle in Endometriosis Health Profile-30 (EHP-30) Domains Score at Treatment Cycle 3
Tidsramme: 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).
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.
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).
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
Tidsramme: 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).
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.
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).
Mean Change From Screening in Bone-Specific Alkaline Phosphatase (BSAP) and Osteocalcin at End of Treatment Cycle 3
Tidsramme: 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).
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.
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).
Mean Change From Screening in N-Telopeptide of Type I Collagen (NTX) at End of Treatment Cycle 3
Tidsramme: 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).
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.
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).
Mean Change From Screening in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b) at End of Treatment Cycle 3
Tidsramme: 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).
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.
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).
Number of Participants With Clinically Significant Laboratory Abnormalities
Tidsramme: 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
Blood samples were collected to determine the clinical laboratory abnormalities. The laboratory assessments included chemistry, hematology and urinalysis.
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
Mean Change From Baseline Cycle in Sum of Days on Period at Treatment Cycles 1, 2 and 3
Tidsramme: 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 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.
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).
Number of Participants With Clinically Significant Electrocardiogram (ECG) Parameters Abnormalities
Tidsramme: 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
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.
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
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
Tidsramme: 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 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.
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).
Mean Change From Screening in Estrone (E1) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Tidsramme: 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 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.
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).
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
Tidsramme: 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 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.
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).
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
Tidsramme: 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.
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).
Mean Change From Screening in Dehydroepiandrosterone Sulfate (DHEAS) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Tidsramme: 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 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.
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).
Plasma Concentrations of OG-6219 and FOR-1011
Tidsramme: 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
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.
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
Maximum Concentration (Cmax) of OG-6219 and FOR-1011
Tidsramme: 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
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.
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
Time Taken to Reach the Maximum Concentration (Tmax) of OG-6219 and FOR-1011
Tidsramme: 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
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.
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
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of OG-6219 and FOR-1011
Tidsramme: 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
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.
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Organon and Co

Samarbejdspartnere

IQVIA Pty Ltd

Efterforskere

  • Studieleder: Clinical Lead Late-Stage Clinical Development, Organon and Co

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. oktober 2022

Primær færdiggørelse (Faktiske)

28. maj 2025

Studieafslutning (Faktiske)

28. maj 2025

Datoer for studieregistrering

Først indsendt

20. september 2022

Først indsendt, der opfyldte QC-kriterier

26. september 2022

Først opslået (Faktiske)

29. september 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OG-6219-P001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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