A phase 2b study to assess the efficacy and safety of OBE2109 in subjects with endometriosis.

Phase 1

• Conditions: Treatment of Endometriosis-Associated Pain; MedDRA version: 20.0Level: SOCClassification code 10038604Term: Reproductive system and breast disordersSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.0Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-001736-35-PL
• Lead Sponsor: ObsEva SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-19
• Study Completion: 2019-09-04
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 328

Inclusion Criteria

MAIN STUDY:
• The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
• The subject has moderate to severe endometriosis-associated pain during the screening period.
• The subject has regular menstrual cycles.
• The subject has a BMI = 18 kg/m2 at the screening visit.
EXTENSION PHASE:
• The subject must have completed Parts A and B (24 weeks) treatment period in the main study.
• The subject is willing and able to continue to comply with the requirements of the study protocol for the duration of the extension.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

MAIN STUDY:
• The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
• The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
• The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
• The subject has a history of, or known osteoporosis or other metabolic bone disease.
• The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.
EXTENSION PHASE:
• The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the extension.
• The subject has at least one ovarian endometrioma with a diameter of 7 cm or greater.
• The subject has BMD loss > 7% at either femoral neck, hip or spine or a Z-score = -2.5 on the Week 24 DXA Scan during the main study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified