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A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

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ClinicalTrials.gov Identifier: NCT03986944
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
ObsEva SA

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: Placebo linzagolix tablets and Placebo Add-back capsule Drug: Placebo linzagolix and linzagolix tablets and Placebo Add-back capsule Drug: Placebo linzagolix and linzagolix tablets and 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.


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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 : May 23, 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

Arm Intervention/treatment
Placebo Comparator: Placebo linzagolix + Placebo Add-back Drug: Placebo linzagolix tablets and Placebo Add-back capsule
For oral administration once daily

Experimental: linzagolix dose 1+Placebo linzagolix dose 2+Placebo Add-back Drug: Placebo linzagolix and linzagolix tablets and Placebo Add-back capsule
For oral administration once daily

Experimental: linzagolix dose 2 + Placebo linzagolix dose 1 + Add-back Drug: Placebo linzagolix and linzagolix tablets and Add-back capsule
For oral administration once daily




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 Verbal Rating Scale (VRS) using an electronic diary

  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 Verbal Rating Scale (VRS) using an electronic diary


Secondary Outcome Measures :
  1. 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

  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 Verbal Rating Scale (VRS) using an electronic diary

  3. 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

  4. 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

  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 Verbal Rating Scale (VRS) using an electronic diary

  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



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

Key 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.

Key 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.

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): NCT03986944


Contacts
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Contact: Chief Medical Officer +41 22 552 38 40 clinicaltrials@obseva.ch

Locations
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United States, Colorado
718 Not yet recruiting
Denver, Colorado, United States, 80209
Principal Investigator: Arthur Waldbaum, MD         
732 Not yet recruiting
Lakewood, Colorado, United States, 80228
Principal Investigator: Michael Johnson, MD         
United States, Florida
750 Not yet recruiting
Boynton Beach, Florida, United States, 33463
Principal Investigator: Sherida Williams, MD         
731 Recruiting
Orlando, Florida, United States, 32801
Principal Investigator: Michael Dever, MD         
779 Recruiting
Orlando, Florida, United States, 32801
Principal Investigator: Anna Lizama Clark, MD         
United States, Georgia
727 Not yet recruiting
Atlanta, Georgia, United States, 30342
Principal Investigator: Richard Zane, MD         
United States, Massachusetts
712 Not yet recruiting
Fall River, Massachusetts, United States, 02720
Principal Investigator: Stephen Kasparian, MD         
United States, New Mexico
707 Not yet recruiting
Albuquerque, New Mexico, United States, 87102
Principal Investigator: Ellen Kim, MD         
United States, Pennsylvania
744 Recruiting
Jenkintown, Pennsylvania, United States, 19046
Principal Investigator: Marvin Kalafer, MD         
United States, Texas
771 Recruiting
Austin, Texas, United States, 78758
Principal Investigator: Mark Akin, MD         
763 Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Cynthia Robbins, MD         
737 Recruiting
League City, Texas, United States, 77573
Principal Investigator: Bassem Maximos, MD         
710 Recruiting
Schertz, Texas, United States, 78154
Principal Investigator: Joseph Garza, MD         
Sponsors and Collaborators
ObsEva SA
Investigators
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Study Director: Lecomte ObsEva SA

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Responsible Party: ObsEva SA
ClinicalTrials.gov Identifier: NCT03986944     History of Changes
Other Study ID Numbers: 18-OBE2109-002
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
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
Genital Diseases, Female