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中等度から重度の子宮内膜症関連の痛みを伴う 18 歳から 49 歳の参加者を対象に、プラセボと比較して 3 つの用量レベルで OG-6219 BID の有効性と安全性を調査する研究 (ELENA)

2026年4月16日 更新者：Organon and Co

中等度から重度の 18 歳から 49 歳の女性を対象に、3 つの用量レベルで OG-6219 の有効性と安全性を評価するためのフェーズ 2a/b 無作為化二重盲検プラセボ対照並行群間多施設臨床試験子宮内膜症関連の痛み

このグローバル第 2 相試験の目的は、中等度から重度の子宮内膜症に関連する 18 歳から 49 歳までの閉経前女性における OG-6219 の 3 つの用量レベルの有効性、安全性、および忍容性を判断することです。痛み。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

これは、18 歳から 49 歳の閉経前の女性を対象に、OG-6219 の 3 つの用量レベルの有効性、安全性、忍容性を評価するための国際的な多施設共同第 2a/b 相無作為化二重盲検プラセボ対照試験です。中等度から重度の子宮内膜症関連の痛みを伴う子宮内膜症と外科的に診断された患者。 この研究には、合計で約 16 週間続く治療が含まれており、安全性のフォローアップが続きます。

外科的に子宮内膜症と診断された18歳から49歳（両端を含む）の閉経前の女性をスクリーニングして、試験治療に無作為に割り当てる。 治療グループ（プラセボグループを含む）あたり10人の参加者の最小サブセットは、研究の全期間にわたって任意の集中的なPKサンプリングに自発的に登録されます。

研究の種類

介入

入学 (実際)

354

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～49年 (大人)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • -インフォームドコンセント（V1）に署名した時点で18〜49歳（両端を含む）の閉経前の女性。
  • 子宮内膜症と診断された外科的（腹腔鏡検査または開腹術）
  • 中等度から重度の子宮内膜症関連の骨盤痛
  • 定期的な月経周期
  • -研究参加中に子宮内膜症の治療のために計画された婦人科手術またはその他の外科的処置を受けることが期待されていません。
  • V1での通常の乳房検査
  • -現在の研究に参加している間、別の介入研究に参加しないことに同意します。
  • -以下を含む研究手順を順守することができ、喜んで順守する
  • -研究を通して2つの形態の非ホルモン避妊法を使用することに同意する
  • -研究関連の活動の前に、署名されたインフォームドコンセントを提供する意思があり、提供できる必要があります
  • eDiary エントリの 75% 以上に準拠していることが実証されています
  • 妊娠検査薬は陰性です

除外基準:

  • -子宮摘出術および/または両側卵巣摘出術の手術歴
  • 慢性鎮痛薬またはその他の慢性治療を必要とする、子宮内膜症に起因しない慢性骨盤痛および/または非骨盤痛
  • -スクリーニング前の過去6か月以内に子宮内膜症に関連しない、診断されていない（説明のつかない）異常な膣出血。
  • ハイリスクヒトパピローマウイルス（HPV）の存在。
  • アクティブな性感染症 (STI) がある (例、淋病、クラミジア、またはトリコモナス)。
  • -研究参加中に妊娠または授乳する予定がある、または妊娠が判明している、または疑われている。
  • -適切に治療された基底細胞または扁平上皮細胞皮膚がんまたは in situ 子宮頸がんを除く、5年以下の悪性腫瘍の病歴。
  • -メトヘモグロビン血症を引き起こす可能性のある遺伝性異常ヘモグロビンまたは酵素欠損症の家族歴。
  • 溶血性貧血に関連する病状がある
  • -活動性、再発性、または慢性感染症を伴う既知のヒト免疫不全ウイルス感染症（例、A型、B型、またはC型肝炎ウイルス）
  • -臨床的に重大な異常なECGまたはQT間隔の延長があります
  • -敏感な基質、中等度、または強力なCYP3A4の阻害剤または誘導剤のいずれかである薬物を、30日以内または10半減期（いずれか長い方）のいずれかで使用しました。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：グループ A: OG-6219 用量 1
グループ A: OG-6219 1 回投与 (BID)
薬：OG-6219
OG-6219 用量 1、用量 2、用量 3 BID: 参加者は治療サイクル中に OG-6219 錠剤を (経口的に) 受け取ります。
実験的：グループ B: OG-6219 用量 2
グループ B: OG-6219 2 回投与 BID
薬：OG-6219
OG-6219 用量 1、用量 2、用量 3 BID: 参加者は治療サイクル中に OG-6219 錠剤を (経口的に) 受け取ります。
実験的：グループ C: OG-6219 用量 3
グループ C: OG-6219 3 回投与 (BID)
薬：OG-6219
OG-6219 用量 1、用量 2、用量 3 BID: 参加者は治療サイクル中に OG-6219 錠剤を (経口的に) 受け取ります。
プラセボコンパレーター：グループ D: プラセボ
グループ D: プラセボ BID
薬：プラセボ
参加者は、治療サイクル中に (経口で) OG-6219 プラセボ錠剤 BID を受け取ります。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
時間枠：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)
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Organon and Co

協力者

IQVIA Pty Ltd

捜査官

  • スタディディレクター：Clinical Lead Late-Stage Clinical Development、Organon and Co

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便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年10月25日

一次修了 (実際)

2025年5月28日

研究の完了 (実際)

2025年5月28日

試験登録日

最初に提出

2022年9月20日

QC基準を満たした最初の提出物

2022年9月26日

最初の投稿 (実際)

2022年9月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月8日

QC基準を満たした最後の更新が送信されました

2026年4月16日

最終確認日

2026年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • OG-6219-P001

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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