Print

Purpose

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

Condition

Eligibility

Eligible Ages
Between 18 Years and 49 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

The subject must have: - Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening. - Moderate to severe endometriosis-associated pain during the screening period. - Regular menstrual cycles. - BMI ≥ 18 kg/m2 at the screening visit.

Exclusion Criteria

The subject will be excluded if she: - Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study. - Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period. - Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening. - Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis. - Has a history of, or known, osteoporosis or other metabolic bone disease. - Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Linzagolix 75 mg
  • Drug: 75 mg linzagolix tablet
    For oral administration once daily
  • Drug: Placebo tablet to match 200 mg linzagolix tablet
    For oral administration once daily
  • Drug: Placebo capsule to match Add-back capsule
    For oral administration once daily
Experimental
Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)
  • Drug: 200 mg linzagolix tablet
    For oral administration once daily
  • Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg)
    For oral administration once daily
  • Drug: Placebo tablet to match 75 mg linzagolix tablet
    For oral administration once daily
Placebo Comparator
Placebo
  • Drug: Placebo tablet to match 75 mg linzagolix tablet
    For oral administration once daily
  • Drug: Placebo tablet to match 200 mg linzagolix tablet
    For oral administration once daily
  • Drug: Placebo capsule to match Add-back capsule
    For oral administration once daily

More Details

Status
Terminated
Sponsor
ObsEva SA

Study Contact

Detailed Description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women. Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.