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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

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date June 14, 2021
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Dysmenorrhea [ Time Frame: Baseline to Month 3 ]
    Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea measured on a Verbal Rating Scale (VRS) using an electronic diary
  • 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 Verbal Rating Scale (VRS) using an electronic diary
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Dysmenorrhea [ Time Frame: Baseline to Month 6 ]
    Change from baseline to Month 6 in dysmenorrhea measured on a Verbal Rating Scale (VRS) using an electronic diary
  • Non-menstrual pelvic pain [ Time Frame: Baseline to Month 6 ]
    Change from baseline to Month 6 in non-menstrual pelvic pain measured on a Verbal Rating Scale (VRS) using an electronic diary
  • Dyschezia [ Time Frame: Baseline to Month 6 ]
    Change from baseline to Month 6 in dyschezia measured on a Numeric Rating Scale (NRS) using an electronic diary
  • Overall Pelvic Pain [ Time Frame: Baseline to Month 6 ]
    Change from baseline to Month 6 in overall pelvic pain measured on a Numeric Rating Scale (NRS) using an electronic diary
  • 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 Verbal Rating Scale (VRS) using an electronic diary
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.
Official Title  ICMJE 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.
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: 75 mg linzagolix tablet
    For oral administration once daily
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Linzagolix 75 mg
    Interventions:
    • Drug: 75 mg linzagolix tablet
    • Drug: Placebo tablet to match 200 mg linzagolix tablet
    • Drug: Placebo capsule to match Add-back capsule
  • Experimental: Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)
    Interventions:
    • 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
  • Placebo Comparator: Placebo
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Females Only
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bulgaria,   Czechia,   France,   Hungary,   Poland,   Romania,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03992846
Other Study ID Numbers  ICMJE 18-OBE2109-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ObsEva SA
Study Sponsor  ICMJE ObsEva SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lecomte ObsEva SA
PRS Account ObsEva SA
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP