Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.
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ClinicalTrials.gov Identifier: NCT03992846 |
Recruitment Status :
Completed
First Posted : June 20, 2019
Last Update Posted : June 21, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometriosis | Drug: 75 mg linzagolix tablet Drug: 200 mg linzagolix tablet Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg) Drug: Placebo tablet to match 75 mg linzagolix tablet Drug: Placebo tablet to match 200 mg linzagolix tablet Drug: Placebo capsule to match Add-back capsule | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 486 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain. |
Actual Study Start Date : | June 13, 2019 |
Actual Primary Completion Date : | October 18, 2021 |
Actual Study Completion Date : | April 1, 2022 |

Arm | Intervention/treatment |
---|---|
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 |
- Dysmenorrhea [ Time Frame: Baseline to Month 3 ]Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.
- Non-menstrual pelvic pain [ Time Frame: Baseline to Month 3 ]Change at Month 3 from baseline in the mean daily assessment of non-menstrual pelvic pain measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.
- Dysmenorrhea [ Time Frame: Baseline to Month 6 ]Change from baseline to Month 6 in dysmenorrhea measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.
- Non-menstrual pelvic pain [ Time Frame: Baseline to Month 6 ]Change from baseline to Month 6 in non-menstrual pelvic pain measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome
- Dyschezia [ Time Frame: Baseline to Month 6 ]Change from baseline to Month 6 in dyschezia measured on a 0-10 Numeric Rating Scale (NRS) using an electronic diary. The lower value represents a better outcome.
- Overall Pelvic Pain [ Time Frame: Baseline to Month 6 ]Change from baseline to Month 6 in overall pelvic pain measured on a 0-10 Numeric Rating Scale (NRS) using an electronic diary. The lower value represents a better outcome.
- Interference of pain with the ability to perform daily activities [ Time Frame: Baseline to Month 6 ]Change from baseline to Month 6 in the interference of pain with the ability to perform daily activities, measured using the pain dimension of the Endometriosis Health Profile-30 (EHP-30) using an electronic diary
- Dyspareunia [ Time Frame: Baseline to Month 6 ]Change from baseline to Month 6 in dyspareunia measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.
- No analgesic use for endometriosis associated pain [ Time Frame: During the preceding 4-week period at Month 6 ]Proportion of subjects reporting no analgesic use for endometriosis associated pain, during the preceding 4-week period at Month 6
- No opiate use for endometriosis associated pain [ Time Frame: During the preceding 4-week period at Month 6 ]Proportion of subjects reporting no opiate use for endometriosis associated pain, during the preceding 4-week period at Month 6

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Females Only |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992846

Study Director: | Lecomte | ObsEva SA |
Responsible Party: | ObsEva SA |
ClinicalTrials.gov Identifier: | NCT03992846 |
Other Study ID Numbers: |
18-OBE2109-003 |
First Posted: | June 20, 2019 Key Record Dates |
Last Update Posted: | June 21, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dysmenorrhea Dyspareunia Dyschezia Non-menstrual pelvic pain |
Endometriosis |