Uno studio per indagare l'efficacia e la sicurezza di OG-6219 BID in 3 livelli di dose rispetto al placebo in partecipanti di età compresa tra 18 e 49 anni con dolore correlato all'endometriosi da moderato a grave (ELENA)
16 aprile 2026 aggiornato da: Organon and Co
Uno studio clinico di fase 2a/b, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico, per valutare l'efficacia e la sicurezza di OG-6219 in 3 livelli di dose, in donne di età compresa tra 18 e 49 anni con malattia da moderata a grave Dolore correlato all'endometriosi
Lo scopo di questo studio globale di fase 2 è determinare l'efficacia, la sicurezza e la tollerabilità di 3 livelli di dose di OG-6219 nelle donne in pre-menopausa tra i 18 e i 49 anni di età (inclusi), che hanno un'endometriosi da moderata a grave Dolore.
Panoramica dello studio
Descrizione dettagliata
Questo è uno studio multicentrico globale, di fase 2a/b, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia, la sicurezza e la tollerabilità di 3 livelli di dose di OG-6219, in donne in pre-menopausa di età compresa tra 18 e 49 anni (incluso), a cui è stata diagnosticata chirurgicamente l'endometriosi con dolore correlato all'endometriosi da moderato a grave. Questo studio include un trattamento della durata totale di circa 16 settimane ed è seguito da un follow-up sulla sicurezza.
Le donne in pre-menopausa di età compresa tra 18 e 49 anni (inclusi), a cui è stata diagnosticata chirurgicamente l'endometriosi, verranno sottoposte a screening per essere assegnate in modo casuale al trattamento in studio. Un sottogruppo minimo di 10 partecipanti per gruppo di trattamento (incluso il gruppo Placebo) sarà arruolato volontariamente per il campionamento PK intensivo facoltativo per l'intera durata dello studio.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
354
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Brussels, Belgio, 1200
- Cliniques Universitaires Saint-Luc
-
Ghent, Belgio, 9000
- Universitair Ziekenhuis Ghent
-
Ghent, Belgio, 9000
- AZ Jan Palfijn Gent
-
Hasselt, Belgio, 3500
- Jessa Ziekenhuis Hospital
-
La Louvière, Belgio, 7100
- CHU de Tivoli
-
-
-
-
-
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
-
-
-
-
-
Brno, Cechia, 602 00
- Fakultni nemocnice Brno
-
Olomouc, Cechia, 77900
- Fertimed s.r.o.
-
Prague, Cechia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
-
Prague, Cechia, 147 10
- Ustav pro peci o matku a dite
-
Prague, Cechia, 130 00
- Femina Sana s.r.o.
-
-
-
-
-
Paris, Francia, 75020
- Hopital Tenon
-
Paris, Francia, 75014
- Hôpital Cochin
-
Strasbourg, Francia, 67200
- Hospital of Hautepierre
-
-
Paris
-
Paris, Paris, Francia, 75674
- Hôpital Saint Joseph Paris
-
-
-
-
-
Berlin, Germania, 13353
- Charite - Campus Benjamin Franklin
-
Homburg, Germania, D-66421
- Universitätsklinikum des Saarlandes
-
-
North Rhine-Westphalia
-
Düsseldorf, North Rhine-Westphalia, Germania, 40225
- Universitaetsklinikum Duesseldorf AoeR
-
-
-
-
-
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
-
-
-
-
-
Riga, Lettonia, LV-1005
- Latvian Maritime Medical Centre
-
Riga, Lettonia, LV-1006
- Vitols & Vitols, Ltd.
-
Riga, Lettonia, LV-1011
- Dr. Vasaraudze's Private Clinic
-
-
-
-
-
Bialystok, Polonia, 15-224
- Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa
-
Bialystok, Polonia, 15-267
- Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
-
Katowice, Polonia, 40-156
- Clinical Medical Research Sp. z o.o.
-
Katowice, Polonia, 40-081
- Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
-
Katowice, Polonia, 40-301
- NZOZ Medem
-
Lodz, Polonia, 91-053
- Centra Medyczne Medyceusz
-
Lublin, Polonia, 20-362
- KO-MED Centra Kliniczne Lublin II
-
Lublin, Polonia, 20-064
- Specjalistyczny Gabinet Ginekologiczno-Położniczy
-
Lublin, Polonia, 20-093
- Centrum Medyczne Chodzki HLK
-
Olsztyn, Polonia, 10-117
- Etyka Osrodek Badan Klinicznych
-
Siedlce, Polonia, 08-110
- ETG Siedlce
-
Szczecin, Polonia, 70-225
- Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
-
Torun, Polonia, 87-100
- MICS Centrum Medyczne Torun
-
Warsaw, Polonia, 02-172
- PRATIA S.A. MTZ Clinical Research Powered by Pratia
-
Warsaw, Polonia, 00-144
- Specjalistyczna Praktyka Lekar
-
Warsaw, Polonia, 04-141
- WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON
-
-
Dolnoslask
-
Wroclaw, Dolnoslask, Polonia, 54-034
- Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.
-
-
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35205
- Central Research Associates LLC dba Flourish Research
-
Birmingham, Alabama, Stati Uniti, 35233
- UAB Center for Women's Reproductive Health
-
-
California
-
Los Angeles, California, Stati Uniti, 90036
- Olympia Clinical Trials
-
-
Connecticut
-
Orange, Connecticut, Stati Uniti, 06477
- Yale Fertility Center
-
-
Florida
-
Sarasota, Florida, Stati Uniti, 34239
- Physician Care Clinical Research, LLC
-
Tampa, Florida, Stati Uniti, 33606
- University of South Florida
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30363
- MediSense Inc
-
College Park, Georgia, Stati Uniti, 30349
- Paramount Research Solutions
-
Morrow, Georgia, Stati Uniti, 30260
- Infinite Clinical Trials
-
-
Illinois
-
Park Ridge, Illinois, Stati Uniti, 60068
- The Advanced Gynecologic Surgery Institute
-
-
Louisiana
-
New Orleans, Louisiana, Stati Uniti, 70115
- Ochsner Health Center - Baptist McFarland Medical Plaza
-
Shreveport, Louisiana, Stati Uniti, 71118
- Omni Fertility and Laser Institute
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21205
- John Hopkins University
-
-
New Mexico
-
Albuquerque, New Mexico, Stati Uniti, 87109
- Bosque Women's Care
-
-
Ohio
-
Cincinnati, Ohio, Stati Uniti, 45267-0502
- University of Cincinnati
-
Dublin, Ohio, Stati Uniti, 43016
- Centricity Research Dublin
-
-
Pennsylvania
-
Hershey, Pennsylvania, Stati Uniti, 17033
- Penn State Health Women's Health Clinic
-
Philadelphia, Pennsylvania, Stati Uniti, 19114
- Clinical Research Of Philadelphia, Llc
-
-
South Carolina
-
Summerville, South Carolina, Stati Uniti, 29485
- Palmetto Clinical Research
-
-
Tennessee
-
Chattanooga, Tennessee, Stati Uniti, 37404
- Chattanooga Medical Research, LLC
-
-
Texas
-
Euless, Texas, Stati Uniti, 76040
- Cedar Health Research, LLC
-
Houston, Texas, Stati Uniti, 77074
- Clinical Trial Network LLC
-
Houston, Texas, Stati Uniti, 77024
- The Women's Hospital of Texas
-
San Antonio, Texas, Stati Uniti, 78233
- Northeast Clinical Research of San Antonio
-
-
Utah
-
Salt Lake City, Utah, Stati Uniti, 84107
- Wasatch Clinical Research
-
-
Virginia
-
Norfolk, Virginia, Stati Uniti, 23502
- Tidewater Clinical Research
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98105
- Seattle Women's: Health, Research, Gynecology
-
-
-
-
-
Stockholm, Svezia, 17176
- Karolinska University Hospital
-
Stockholm, Svezia, 182 88
- Danderyd Sjukhus
-
-
-
-
-
Budapest, Ungheria, 1033
- ClinExpert Kft.
-
Budapest, Ungheria, 1082
- Semmelweis Egyetem
-
Debrecen, Ungheria, 4024
- Szent Anna Maganrendelo
-
Kaposvár, Ungheria, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Nyíregyháza, Ungheria, 4400
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 49 anni (Adulto)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- Donne in pre-menopausa di età compresa tra 18 e 49 anni (inclusi) al momento della firma del consenso informato (V1).
- Chirurgicamente (laparoscopia o laparotomia) diagnosticata con endometriosi
- Dolore pelvico correlato all'endometriosi da moderato a grave
- Cicli mestruali regolari
- Non si prevede di sottoporsi a un intervento chirurgico ginecologico programmato o ad altre procedure chirurgiche per il trattamento dell'endometriosi durante la partecipazione allo studio.
- Esame del seno normale a V1
- Accetta di non partecipare a un altro studio interventistico durante la partecipazione al presente studio.
- In grado e disposto ad aderire alle procedure di studio, incluso
- accettare di utilizzare 2 forme di contraccezione non ormonale durante lo studio
- Deve essere disposto e in grado di fornire il consenso informato firmato prima di qualsiasi attività correlata allo studio
- Ha dimostrato la conformità con ≥75% delle voci di eDiary
- Ha un test di gravidanza negativo
Criteri di esclusione:
- Anamnesi chirurgica di isterectomia e/o ovariectomia bilaterale
- Dolore cronico pelvico e/o non pelvico non causato da endometriosi che richiede analgesici cronici o altre terapie croniche
- Sanguinamento vaginale anomalo non diagnosticato (inspiegabile) non associato a endometriosi negli ultimi 6 mesi prima dello screening.
- Presenza di papillomavirus umano (HPV) ad alto rischio.
- Ha un'infezione a trasmissione sessuale attiva (STI) (p. es., gonorrea, clamidia o trichomonas).
- Intende rimanere incinta o allattare al seno durante la partecipazione allo studio o ha una gravidanza nota o sospetta.
- Storia di malignità ≤5 anni ad eccezione di carcinoma cutaneo basocellulare o a cellule squamose adeguatamente trattato o carcinoma cervicale in situ.
- Anamnesi familiare di emoglobina anomala ereditaria o deficit enzimatico che può provocare metaemoglobinemia.
- Ha una condizione medica associata all'anemia emolitica
- Infezione da virus dell'immunodeficienza umana nota, con infezione attiva, ricorrente o cronica (p. es., virus dell'epatite A, B o C)
- Presenta un ECG anomalo clinicamente significativo o un prolungamento dell'intervallo QT
- Utilizzato qualsiasi farmaco che sia un substrato sensibile, un inibitore o un induttore moderato o forte del CYP3A4 entro 30 giorni o 10 emivite (a seconda di quale sia il più lungo) prima del primo giorno di somministrazione pianificato.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Gruppo A: OG-6219 Dose 1
Gruppo A: OG-6219 Dose 1 BID
|
OG-6219 Dose 1, Dose 2, Dose 3 BID: i partecipanti riceveranno (per via orale) compresse di OG-6219 durante i cicli di trattamento.
|
|
Sperimentale: Gruppo B: OG-6219 Dose 2
Gruppo B: OG-6219 Dose 2 BID
|
OG-6219 Dose 1, Dose 2, Dose 3 BID: i partecipanti riceveranno (per via orale) compresse di OG-6219 durante i cicli di trattamento.
|
|
Sperimentale: Gruppo C: OG-6219 Dose 3
Gruppo C: OG-6219 Dose 3 BID
|
OG-6219 Dose 1, Dose 2, Dose 3 BID: i partecipanti riceveranno (per via orale) compresse di OG-6219 durante i cicli di trattamento.
|
|
Comparatore placebo: Gruppo D: placebo
Gruppo D: Placebo BID
|
I partecipanti riceveranno (per via orale) compresse di placebo OG-6219 BID durante i cicli di trattamento.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Clinical Lead Late-Stage Clinical Development, Organon and Co
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
25 ottobre 2022
Completamento primario (Effettivo)
28 maggio 2025
Completamento dello studio (Effettivo)
28 maggio 2025
Date di iscrizione allo studio
Primo inviato
20 settembre 2022
Primo inviato che soddisfa i criteri di controllo qualità
26 settembre 2022
Primo Inserito (Effettivo)
29 settembre 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 aprile 2026
Ultimo verificato
1 marzo 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OG-6219-P001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .