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Um estudo para investigar a eficácia e a segurança do OG-6219 BID em 3 níveis de dosagem em comparação com o placebo em participantes de 18 a 49 anos com dor moderada a grave relacionada à endometriose (ELENA)

16 de abril de 2026 atualizado por: Organon and Co

Fase 2a/b, randomizado, duplo-cego, controlado por placebo, grupo paralelo, multicêntrico, estudo clínico para avaliar a eficácia e segurança de OG-6219 em 3 níveis de dosagem, em mulheres de 18 a 49 anos de idade com moderado a grave Dor relacionada à endometriose

O objetivo deste estudo global de Fase 2 é determinar a eficácia, segurança e tolerabilidade de 3 níveis de dose de OG-6219 em mulheres na pré-menopausa entre 18 e 49 anos de idade (inclusive), que têm endometriose moderada a grave relacionada dor.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Este é um estudo multicêntrico global, Fase 2a/b, randomizado, duplo-cego, controlado por placebo para avaliar a eficácia, segurança e tolerabilidade de 3 níveis de dose de OG-6219, em mulheres na pré-menopausa de 18 a 49 anos de idade (inclusive), que foram diagnosticadas cirurgicamente com endometriose com dor moderada a grave relacionada à endometriose. Este estudo inclui tratamento com duração de aproximadamente 16 semanas no total e é seguido por um Acompanhamento de Segurança.

Mulheres na pré-menopausa com idade entre 18 e 49 anos (inclusive), que foram diagnosticadas cirurgicamente com endometriose serão rastreadas para designar aleatoriamente o tratamento do estudo. Um subconjunto mínimo de 10 participantes por grupo de tratamento (incluindo o grupo Placebo) será voluntariamente inscrito para amostragem farmacocinética intensiva opcional durante toda a duração do estudo.

Tipo de estudo

Intervencional

Inscrição (Real)

354

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 49 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Mulheres na pré-menopausa com idade entre 18 e 49 anos (inclusive) no momento da assinatura do Termo de Consentimento Livre e Esclarecido (V1).
  • Cirurgicamente (laparoscopia ou laparotomia) diagnosticada com endometriose
  • Dor pélvica moderada a grave relacionada à endometriose
  • Ciclos menstruais regulares
  • Não se espera passar por uma cirurgia ginecológica planejada ou outros procedimentos cirúrgicos para tratamento de endometriose durante a participação no estudo.
  • Exame de mama normal em V1
  • Concorde em não participar de outro estudo de intervenção enquanto estiver participando do presente estudo.
  • Capaz e disposto a aderir aos procedimentos do estudo, incluindo
  • concorda em usar 2 formas de contracepção não hormonal ao longo do estudo
  • Deve estar disposto e ser capaz de fornecer consentimento informado assinado antes de qualquer atividade relacionada ao estudo
  • Demonstrou conformidade com ≥75% das entradas do eDiary
  • Tem um teste de gravidez negativo

Critério de exclusão:

  • História cirúrgica de histerectomia e/ou ooforectomia bilateral
  • Dor pélvica crônica e/ou não pélvica não causada por endometriose que requer analgésicos crônicos ou outra terapia crônica
  • Sangramento vaginal anormal não diagnosticado (inexplicável) não associado à endometriose nos últimos 6 meses antes da triagem.
  • Presença de papilomavírus humano (HPV) de alto risco.
  • Tem uma infecção sexualmente transmissível (DST) ativa (por exemplo, gonorréia, clamídia ou trichomonas).
  • Pretende engravidar ou amamentar durante a participação no estudo ou tem gravidez conhecida ou suspeita.
  • História de malignidade ≤ 5 anos, exceto para câncer de pele basocelular ou escamoso adequadamente tratado ou câncer cervical in situ.
  • História de história familiar de hemoglobina anormal hereditária ou deficiência enzimática que pode resultar em metemoglobinemia.
  • Tem uma condição médica associada à anemia hemolítica
  • Infecção conhecida pelo vírus da imunodeficiência humana, com infecção ativa, recorrente ou crônica (por exemplo, vírus da hepatite A, B ou C)
  • Tem um ECG anormal clinicamente significativo ou prolongamento do intervalo QT
  • Usou qualquer medicamento que seja um substrato sensível, inibidor moderado ou forte ou indutor do CYP3A4 dentro de 30 dias ou 10 meias-vidas (o que for mais longo) antes do primeiro dia planejado de dosagem.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Grupo A: OG-6219 Dose 1
Grupo A: OG-6219 Dose 1 BID
Medicamento: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Os participantes receberão (por via oral) comprimidos de OG-6219 durante os ciclos de tratamento.
Experimental: Grupo B: OG-6219 Dose 2
Grupo B: OG-6219 Dose 2 BID
Medicamento: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Os participantes receberão (por via oral) comprimidos de OG-6219 durante os ciclos de tratamento.
Experimental: Grupo C: OG-6219 Dose 3
Grupo C: OG-6219 Dose 3 BID
Medicamento: OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Os participantes receberão (por via oral) comprimidos de OG-6219 durante os ciclos de tratamento.
Comparador de Placebo: Grupo D: Placebo
Grupo D: Placebo BID
Medicamento: Placebo
Os participantes receberão (por via oral) comprimidos de placebo OG-6219 BID durante os ciclos de tratamento.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Prazo: 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)
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Organon and Co

Colaboradores

IQVIA Pty Ltd

Investigadores

  • Diretor de estudo: Clinical Lead Late-Stage Clinical Development, Organon and Co

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de outubro de 2022

Conclusão Primária (Real)

28 de maio de 2025

Conclusão do estudo (Real)

28 de maio de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

20 de setembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de setembro de 2022

Primeira postagem (Real)

29 de setembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de abril de 2026

Última verificação

1 de março de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • OG-6219-P001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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