Informations générales (source: ClinicalTrials.gov)
A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain (ELENA)
Interventional
Phase 2
Organon and Co (Voir sur ClinicalTrials)
octobre 2022
décembre 2024
17 octobre 2024
The purpose of this global Phase 2 study is to determine the efficacy, safety, and
tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years
of age (inclusive), who have moderate to severe endometriosis-related pain.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Beaujon | Nizar Aflak | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Louis Marcellin | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Nathalie Chabbert Buffet | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Eric Bautrant | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hospital of Hautepierre - 67200 - Strasbourg - France | Emilie Faller | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing
Informed Consent (V1).
- Surgically (laparoscopy or laparotomy) diagnosed with endometriosis
- Moderate to severe endometriosis-related pelvic pain
- Regular menstrual cycles
- Is not expected to undergo a planned gynecological surgery or other surgical
procedures for treatment of endometriosis during study participation.
- Normal breast exam at V1. In participants of ≥40 years mammography or
contrast-enhanced breast MRI performed within the last 12 months prior to Screening
(V1) without clinically significant abnormal findings.
- Agree not to participate in another interventional study while participating in the
present study.
- Able and willing to adhere to study procedures, including
- agree to use 2 forms of non-hormonal contraception throughout the study
- Must be willing and able to provide signed informed consent before any study-related
activities
- Has demonstrated compliance with ≥75% of eDiary entries
- Has a negative pregnancy test
- Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing
Informed Consent (V1).
- Surgically (laparoscopy or laparotomy) diagnosed with endometriosis
- Moderate to severe endometriosis-related pelvic pain
- Regular menstrual cycles
- Is not expected to undergo a planned gynecological surgery or other surgical
procedures for treatment of endometriosis during study participation.
- Normal breast exam at V1. In participants of ≥40 years mammography or
contrast-enhanced breast MRI performed within the last 12 months prior to Screening
(V1) without clinically significant abnormal findings.
- Agree not to participate in another interventional study while participating in the
present study.
- Able and willing to adhere to study procedures, including
- agree to use 2 forms of non-hormonal contraception throughout the study
- Must be willing and able to provide signed informed consent before any study-related
activities
- Has demonstrated compliance with ≥75% of eDiary entries
- Has a negative pregnancy test
- Surgical history of hysterectomy and/or bilateral oophorectomy
- Chronic pelvic and/or non-pelvic pain not caused by endometriosis that requires
chronic analgesic or other chronic therapy
- Undiagnosed (unexplained), abnormal vaginal bleeding not associated with
endometriosis within the past 6 months before screening.
- Presence of high-risk human papillomavirus (HPV).
- Has an active sexually transmitted infection (STI) (eg, gonorrhea, chlamydia, or
trichomonas).
- Intends to become pregnant or breast feed during study participation or has a known
or suspected pregnancy.
- History of malignancy (except for basal cell or squamous cell skin cancer) before
signing informed consent.
- History of family history of hereditary abnormal hemoglobin or an enzyme deficiency
that can result in methemoglobinemia.
- Has a medical condition associated with hemolytic anemia
- Known human immunodeficiency virus infection, and/or acute or active,
recurrent/relapsing, or chronic infection (eg, hepatitis A, B, or C virus)
- Has a clinically significant abnormal ECG or QT interval prolongation
- Used any medication that is either a sensitive substrate, moderate, or strong
inhibitor or inducer of CYP3A4 within 30 days or 10 half-lives (whichever is longer)
prior to the planned first day of dosing.