Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Eine Studie zur Untersuchung der Wirksamkeit und Sicherheit von OG-6219 BID in 3 Dosierungsstufen im Vergleich zu Placebo bei Teilnehmern im Alter von 18 bis 49 Jahren mit mittelschweren bis schweren Endometriose-bedingten Schmerzen (ELENA)

16. April 2026 aktualisiert von: Organon and Co

Eine randomisierte, doppelblinde, Placebo-kontrollierte, multizentrische, klinische Parallelgruppenstudie der Phase 2a/b zur Bewertung der Wirksamkeit und Sicherheit von OG-6219 in 3 Dosierungsstufen bei Frauen im Alter von 18 bis 49 Jahren mit mittelschwerem bis schwerem Verlauf Endometriose-bedingte Schmerzen

Der Zweck dieser globalen Phase-2-Studie ist es, die Wirksamkeit, Sicherheit und Verträglichkeit von 3 Dosierungsstufen von OG-6219 bei prämenopausalen Frauen zwischen 18 und 49 Jahren (einschließlich) zu bestimmen, die an mittelschwerer bis schwerer Endometriose leiden Schmerz.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Dies ist eine globale, multizentrische, randomisierte, doppelblinde, Placebo-kontrollierte Phase-2a/b-Studie zur Bewertung der Wirksamkeit, Sicherheit und Verträglichkeit von 3 Dosierungsstufen von OG-6219 bei prämenopausalen Frauen im Alter von 18 bis 49 Jahren (einschließlich), bei denen Endometriose chirurgisch diagnostiziert wurde, mit mäßigen bis schweren Endometriose-bedingten Schmerzen. Diese Studie umfasst eine Behandlung, die insgesamt etwa 16 Wochen dauert, gefolgt von einem Sicherheits-Follow-up.

Prämenopausale Frauen im Alter von 18 bis 49 Jahren (einschließlich), bei denen Endometriose chirurgisch diagnostiziert wurde, werden gescreent, um sie zufällig der Studienbehandlung zuzuweisen. Eine Mindestuntergruppe von 10 Teilnehmern pro Behandlungsgruppe (einschließlich Placebo-Gruppe) wird freiwillig für die optionale intensive PK-Probenahme für die gesamte Dauer der Studie eingeschrieben.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

354

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 49 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Frauen vor der Menopause im Alter von 18 bis 49 Jahren (einschließlich) zum Zeitpunkt der Unterzeichnung der Einverständniserklärung (V1).
  • Chirurgisch (Laparoskopie oder Laparotomie) mit Endometriose diagnostiziert
  • Mittelschwere bis schwere Endometriose-bedingte Beckenschmerzen
  • Regelmäßige Menstruationszyklen
  • Es wird nicht erwartet, dass sie sich während der Studienteilnahme einer geplanten gynäkologischen Operation oder anderen chirurgischen Eingriffen zur Behandlung der Endometriose unterzieht.
  • Normale Brustuntersuchung bei V1
  • Stimmen Sie zu, während der Teilnahme an der vorliegenden Studie nicht an einer anderen Interventionsstudie teilzunehmen.
  • Fähigkeit und Bereitschaft, sich an Studienverfahren zu halten, einschließlich
  • stimmen zu, während der gesamten Studie 2 Formen der nicht-hormonellen Empfängnisverhütung zu verwenden
  • Muss bereit und in der Lage sein, vor allen studienbezogenen Aktivitäten eine unterschriebene Einverständniserklärung abzugeben
  • Hat die Einhaltung von ≥75 % der eDiary-Einträge nachgewiesen
  • Hat einen negativen Schwangerschaftstest

Ausschlusskriterien:

  • Chirurgische Anamnese einer Hysterektomie und/oder bilateralen Ovarektomie
  • Chronischer Unterbauch- und/oder nicht-unterbaucher Schmerz, der nicht durch Endometriose verursacht wird und eine chronische analgetische oder andere chronische Therapie erfordert
  • Nicht diagnostizierte (ungeklärte), abnormale vaginale Blutungen, die nicht mit Endometriose in den letzten 6 Monaten vor dem Screening in Zusammenhang stehen.
  • Vorhandensein von humanem Papillomavirus (HPV) mit hohem Risiko.
  • Hat eine aktive sexuell übertragbare Infektion (STI) (z. B. Gonorrhö, Chlamydien oder Trichomonaden).
  • beabsichtigt, während der Studienteilnahme schwanger zu werden oder zu stillen oder hat eine bekannte oder vermutete Schwangerschaft.
  • Malignität in der Anamnese ≤ 5 Jahre, außer bei angemessen behandeltem Basalzell- oder Plattenepithelkarzinom oder In-situ-Zervixkarzinom.
  • Familienanamnese mit erblich bedingtem abnormalem Hämoglobin oder einem Enzymmangel, der zu Methämoglobinämie führen kann.
  • Hat eine Erkrankung im Zusammenhang mit hämolytischer Anämie
  • Bekannte Infektion mit dem humanen Immundefizienzvirus mit aktiver, rezidivierender oder chronischer Infektion (z. B. Hepatitis-A-, -B- oder -C-Virus)
  • Hat eine klinisch signifikante abnormale EKG- oder QT-Intervallverlängerung
  • Verwendet ein Medikament, das entweder ein empfindliches Substrat, ein mäßiger oder starker Inhibitor oder Induktor von CYP3A4 innerhalb von 30 Tagen oder 10 Halbwertszeiten (je nachdem, was länger ist) vor dem geplanten ersten Tag der Dosierung ist.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Gruppe A: OG-6219 Dosis 1
Gruppe A: OG-6219 Dosis 1 BID
Arzneimittel: OG-6219
OG-6219 Dosis 1, Dosis 2, Dosis 3 BID: Die Teilnehmer erhalten während der Behandlungszyklen (oral) OG-6219-Tabletten.
Experimental: Gruppe B: OG-6219 Dosis 2
Gruppe B: OG-6219 Dosis 2 BID
Arzneimittel: OG-6219
OG-6219 Dosis 1, Dosis 2, Dosis 3 BID: Die Teilnehmer erhalten während der Behandlungszyklen (oral) OG-6219-Tabletten.
Experimental: Gruppe C: OG-6219 Dosis 3
Gruppe C: OG-6219 Dosis 3 BID
Arzneimittel: OG-6219
OG-6219 Dosis 1, Dosis 2, Dosis 3 BID: Die Teilnehmer erhalten während der Behandlungszyklen (oral) OG-6219-Tabletten.
Placebo-Komparator: Gruppe D: Placebo
Gruppe D: Placebo-Gebot
Arzneimittel: Placebo
Die Teilnehmer erhalten (oral) OG-6219 Placebo-Tabletten BID während der Behandlungszyklen.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Organon and Co

Mitarbeiter

IQVIA Pty Ltd

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. Oktober 2022

Primärer Abschluss (Tatsächlich)

28. Mai 2025

Studienabschluss (Tatsächlich)

28. Mai 2025

Studienanmeldedaten

Zuerst eingereicht

20. September 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. September 2022

Zuerst gepostet (Tatsächlich)

29. September 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. April 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • OG-6219-P001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Endometriose

Klinische Studien zur Placebo

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Croatia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren