Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Tutkimus OG-6219 BID:n tehokkuuden ja turvallisuuden tutkimiseksi kolmella annoksella lumelääkkeeseen verrattuna 18–49-vuotiailla osallistujilla, joilla on kohtalainen tai vaikea endometrioosiin liittyvä kipu (ELENA)

torstai 16. huhtikuuta 2026 päivittänyt: Organon and Co

Vaihe 2a/b, satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, rinnakkaisryhmä, monikeskus, kliininen tutkimus OG-6219:n tehon ja turvallisuuden arvioimiseksi 3 annostasolla 18–49-vuotiailla naisilla, joilla on kohtalainen tai vaikea Endometrioosiin liittyvä kipu

Tämän maailmanlaajuisen vaiheen 2 tutkimuksen tarkoituksena on määrittää kolmen OG-6219-annoksen teho, turvallisuus ja siedettävyys premenopausaalisilla 18–49-vuotiailla naisilla (mukaan lukien), joilla on kohtalainen tai vaikea endometrioosiin liittyvä. kipu.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Tämä on maailmanlaajuinen monikeskus, vaiheen 2a/b, satunnaistettu, kaksoissokkoutettu, lumekontrolloitu tutkimus, jossa arvioidaan kolmen OG-6219-annoksen tehoa, turvallisuutta ja siedettävyyttä premenopausaalisilla 18–49-vuotiailla naisilla. (mukaan lukien), joilla on kirurgisesti diagnosoitu endometrioosi, johon liittyy kohtalaista tai vaikeaa endometrioosiin liittyvää kipua. Tämä tutkimus sisältää hoidon, joka kestää yhteensä noin 16 viikkoa, ja sitä seuraa turvallisuusseuranta.

Premenopausaaliset 18–49-vuotiaat (mukaan lukien) naiset, joilla on kirurgisesti diagnosoitu endometrioosi, seulotaan satunnaisesti tutkimushoitoon. Vähintään 10 osallistujan alaryhmä hoitoryhmää kohden (mukaan lukien lumeryhmä) otetaan vapaaehtoisesti mukaan valinnaiseen intensiiviseen PK-näytteenottoon koko tutkimuksen ajan.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

354

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 49 vuotta (Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  • Premenopausaaliset naiset 18–49-vuotiaat (mukaan lukien) Ilmoitetun suostumuksen allekirjoitushetkellä (V1).
  • Kirurgisesti (laparoskopia tai laparotomia) diagnosoitu endometrioosi
  • Kohtalainen tai vaikea endometrioosiin liittyvä lantion kipu
  • Säännölliset kuukautiskierrot
  • Hänen ei odoteta käyvän suunnitteilla gynekologista leikkausta tai muita kirurgisia toimenpiteitä endometrioosin hoitamiseksi tutkimukseen osallistumisen aikana.
  • Normaali rintojen tutkimus V1
  • Sitoudu olemaan osallistumatta toiseen interventiotutkimukseen osallistuessasi tähän tutkimukseen.
  • Pystyy ja haluaa noudattaa opiskelumenettelyjä, mukaan lukien
  • suostuvat käyttämään kahta ei-hormonaalista ehkäisyä koko tutkimuksen ajan
  • On oltava halukas ja kyettävä antamaan allekirjoitettu tietoinen suostumus ennen kaikkea tutkimukseen liittyvää toimintaa
  • On osoittanut noudattavansa ≥ 75 % eDiary-merkinnöistä
  • On negatiivinen raskaustesti

Poissulkemiskriteerit:

  • Leikkaushistoria kohdunpoistosta ja/tai molemminpuolisesta munanpoistosta
  • Krooninen lantion ja/tai ei-lantion kipu, joka ei johdu endometrioosista ja vaatii kroonista kipua tai muuta kroonista hoitoa
  • Diagnosoimaton (selittämätön), epänormaali emättimen verenvuoto, joka ei liity endometrioosiin viimeisten 6 kuukauden aikana ennen seulontaa.
  • Korkean riskin ihmisen papilloomaviruksen (HPV) esiintyminen.
  • Hänellä on aktiivinen sukupuolitauti (STI) (esim. tippuri, klamydia tai trichomonas).
  • Aikoo tulla raskaaksi tai imettää tutkimukseen osallistumisen aikana tai hänellä on tiedossa tai epäilty raskaus.
  • Pahanlaatuinen kasvain historiassa ≤5 vuotta lukuun ottamatta riittävästi hoidettua tyvisolu- tai levyepiteelisyöpää tai in situ kohdunkaulansyöpää.
  • Suvussa on esiintynyt perinnöllistä epänormaalia hemoglobiinia tai entsyymipuutos, joka voi johtaa methemoglobinemiaan.
  • Hänellä on hemolyyttiseen anemiaan liittyvä sairaus
  • Tunnettu ihmisen immuunikatovirusinfektio, johon liittyy aktiivinen, toistuva tai krooninen infektio (esim. hepatiitti A-, B- tai C-virus)
  • Hänellä on kliinisesti merkitsevä epänormaali EKG- tai QT-ajan pidentyminen
  • Käyttänyt mitä tahansa lääkettä, joka on joko herkkä substraatti, kohtalainen tai voimakas CYP3A4:n estäjä tai indusoija 30 päivän tai 10 puoliintumisajan (sen mukaan kumpi on pidempi) sisällä ennen suunniteltua ensimmäistä annostuspäivää.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Ryhmä A: OG-6219, annos 1
Ryhmä A: OG-6219 Annos 1 BID
Lääke: OG-6219
OG-6219 Annos 1, Annos 2, Annos 3 BID: Osallistujat saavat (suun kautta) OG-6219-tabletteja hoitojaksojen aikana.
Kokeellinen: Ryhmä B: OG-6219, annos 2
Ryhmä B: OG-6219 Annos 2 BID
Lääke: OG-6219
OG-6219 Annos 1, Annos 2, Annos 3 BID: Osallistujat saavat (suun kautta) OG-6219-tabletteja hoitojaksojen aikana.
Kokeellinen: Ryhmä C: OG-6219, annos 3
Ryhmä C: OG-6219 Annos 3 BID
Lääke: OG-6219
OG-6219 Annos 1, Annos 2, Annos 3 BID: Osallistujat saavat (suun kautta) OG-6219-tabletteja hoitojaksojen aikana.
Placebo Comparator: Ryhmä D: Placebo
Ryhmä D: Placebo BID
Lääke: Plasebo
Osallistujat saavat (suun kautta) OG-6219 lumetabletteja kahdesti päivässä hoitojaksojen aikana.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Organon and Co

Yhteistyökumppanit

IQVIA Pty Ltd

Tutkijat

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

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 25. lokakuuta 2022

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 28. toukokuuta 2025

Opintojen valmistuminen (Todellinen)

Keskiviikko 28. toukokuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 20. syyskuuta 2022

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 26. syyskuuta 2022

Ensimmäinen Lähetetty (Todellinen)

Torstai 29. syyskuuta 2022

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 8. toukokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 16. huhtikuuta 2026

Viimeksi vahvistettu

Sunnuntai 1. maaliskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • OG-6219-P001

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa