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SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

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ClinicalTrials.gov Identifier: NCT03654274
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

August 29, 2018
August 31, 2018
August 31, 2018
May 22, 2018
December 30, 2020   (Final data collection date for primary outcome measure)
  • Proportion of women who respond or maintain a response on daily assessment of dysmenorrhea [ Time Frame: 52 Weeks ]
    Assessed using a Numerical Rating Scale (NRS) score (11-point scale) for pain recorded daily in an electronic diary.
  • Proportion women who respond or maintain a response based on daily assessment of nonmenstrual pelvic pain [ Time Frame: 52 Weeks ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an electronic diary.
Same as current
No Changes Posted
  • Change in function due to endometriosis associated pain [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed using the Pain Domain of the Endometriosis Health Profile (EHP)-30 questionnaire.
  • Change in dysmenorrhea NRS scores [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an electronic diary.
  • Change in nonmenstrual pelvic pain NRS scores [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an electronic diary.
  • Change in dyspareunia NRS scores [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an electronic diary.
  • Patient Global Impression of Change (PGIC) for dysmenorrhea [ Time Frame: from parent study Baseline up to Week 52 ]
    The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participants impression of change in the severity of pain during their menstrual cycle.
  • Patient Global Impression of Change (PGIC) for nonmenstrual pelvic pain [ Time Frame: from parent study Baseline up to Week 52 ]
    The PGIC for nonmenstrual pelvic pain is a 1-item questionnaire designed to assess participants impression of change in the severity of pain when they are not menstruating.
  • Patient Global Impression of Change (PGIC) for dyspareunia [ Time Frame: from parent study Baseline up to Week 52 ]
    The PGIC for dyspareunia is a 1-item questionnaire designed to assess participants impression of change in the severity of their pain during sexual intercourse.
  • Change in the mean dysmenorrhea functional impairment [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed using the subject modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an electronic diary.
  • Change in the mean nonmenstrual pelvic pain functional impairment [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed using the subject modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an electronic diary.
  • Change in the mean dyspareunia functional impairment [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed using the subject modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an electronic diary.
  • Change in Patient Global Assessment (PGA) for function [ Time Frame: from parent study Baseline up to Week 52 ]
    The PGA for function is a 1-item questionnaire designed to assess participants impression of how their pain affected their usual activities.
  • Change in Patient Global Assessment (PGA) for pain [ Time Frame: from parent study Baseline up to Week 52 ]
    The PGA for function is a 1-item questionnaire designed to assess participants impression of the severity of their pain.
  • Bone Mineral Density (BMD) [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed by dual-energy X-ray absorptiometry (DXA) scan.
  • The number and percentage of participants with adverse events (AE) as a measure of safety and tolerability [ Time Frame: up to 52 weeks ]
    Assessed frequency and severity of AEs and serious AEs.
  • Serum concentrations of estradiol [ Time Frame: up to 52 weeks ]
    Blood samples will be collected from participants for estradiol measurements.
Same as current
Not Provided
Not Provided
 
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain
The purpose of this study is to determine the long-term efficacy and safety of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on endometriosis-associated pain in patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).

This study is an international phase 3 open-label, single arm, long-term efficacy and safety extension study that will enroll eligible patients who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3101 (SPIRIT 1 - NCT03204318) or MVT-601-3102 (SPIRIT 2 - NCT03204331). All patients will receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.

Approximately 800 women with endometriosis-associated pain will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose estradiol/norethindrone acetate.

Screening and baseline procedures will be done at the same visit for this extension study (referred to as the "Week 24/Baseline Visit"), which coincides with the Week 24 visit from the parent study, and will be defined as the date of completion of the last Week 24 procedure in the parent study. Patients will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the patient is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3103 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 28 weeks.

Interventional
Phase 3
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label extension
Masking: None (Open Label)
Primary Purpose: Treatment
Endometriosis Related Pain
  • Drug: Relugolix
    Relugolix 40 mg tablet administered orally once daily
    Other Name: TAK-385
  • Drug: Estradiol/norethindrone acetate
    Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
    Other Names:
    • E2/NETA
    • low-dose hormonal add-back
Experimental: Relugolix plus estradiol/norethindrone acetate
Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.
Interventions:
  • Drug: Relugolix
  • Drug: Estradiol/norethindrone acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
800
Same as current
March 31, 2021
December 30, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

1. Completed 24 weeks of study drug treatment and study participation in either MVT-601-3101 or MVT-601-3102.

Exclusion Criteria:

  1. Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
  2. Met a withdrawal criterion in the parent study (MVT-601-3101 or MVT-601-3102).
Sexes Eligible for Study: Female
18 Years to 51 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03654274
MVT-601-3103
2017-004066-10 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Myovant Sciences GmbH
Myovant Sciences GmbH
Not Provided
Not Provided
Myovant Sciences GmbH
August 2018

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