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Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

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ClinicalTrials.gov Identifier: NCT03992846
Recruitment Status : Active, not recruiting
First Posted : June 20, 2019
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
ObsEva SA

Study Description
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Brief Summary:
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 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 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
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
ObsEva SA
Investigators
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Study Director: Lecomte ObsEva SA
More Information
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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 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ObsEva SA:
Dysmenorrhea
Dyspareunia
Dyschezia
Non-menstrual pelvic pain
Additional relevant MeSH terms:
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Endometriosis