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Trial record 3 of 21 for:    relugolix

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03654274
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Tracking Information
First Submitted Date  ICMJE August 29, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE May 22, 2018
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Proportion Of Women Who Respond Or Maintain Response Based On Assessment Of Dysmenorrhea At Week 52 And Week 104 [ Time Frame: Week 52 and Week 104 ]
    Assessed using a Numerical Rating Scale (NRS) score (11-point scale) for pain recorded daily in an electronic diary (e-Diary).
  • Proportion Of Women Who Respond Or Maintain Response Based On Assessment Of Non-Menstrual Pelvic Pain (NMPP) At Week 52 And Week 104 [ Time Frame: Week 52 and Week 104 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an e-Diary.
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Change From The Parent Study Baseline In Function Due To Endometriosis-associated Pain At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using the Pain Domain of the Endometriosis Health Profile (EHP)-30 questionnaire.
  • Change From Parent Study Baseline In Dysmenorrhea NRS Scores At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an e-Diary.
  • Change From Parent Study Baseline In Mean NMPP NRS Scores At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an e-Diary.
  • Change From Parent Study Baseline In Dyspareunia NRS Scores At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using a NRS score (11-point scale) for pain recorded daily in an e-Diary.
  • Change From Parent Study Baseline In Overall NRS Scores At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using a NRS score (11-point scale) for overall pain recorded daily in an e-Diary.
  • Proportion Of Participants Not Using Opioids At Week 52 And Week 104 [ Time Frame: Week 52 and Week 104 ]
    Assessed using study-specified opioids recorded daily in e-Diary.
  • Proportion Of Participants Not Using Rescue Analgesics At Week 52 And Week 104 [ Time Frame: Week 52 and Week 104 ]
    Assessed using study-specified opioids recorded daily in e-Diary.
  • Proportion Of Participants Who Are Better Or Much Better On The Patient Global Impression Of Change (PGIC) For Dysmenorrhea At Week 52 [ Time Frame: Week 52 ]
    The PGIC for dysmenorrhea is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain during their menstrual cycle.
  • Proportion Of Participants Who Are Better Or Much Better On The PGIC For NMPP At Week 52 [ Time Frame: Week 52 ]
    The PGIC for NMPP is a 1-item questionnaire designed to assess participant's impression of change in the severity of pain when they are not menstruating.
  • Proportion Of Participants Who Are Better Or Much Better On PGIC For Dyspareunia At Week 52 [ Time Frame: Week 52 ]
    The PGIC for dyspareunia is a 1-item questionnaire designed to assess participant's impression of change in the severity of their pain during sexual intercourse.
  • Change From Parent Study Baseline In The Mean Dysmenorrhea Functional Impairment At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using the subject-modified Biberoglu and Behrman 5-point scale for dysmenorrhea recorded daily in an e-Diary.
  • Change From Parent Study Baseline In The Mean NMPP Functional Impairment At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using the subject-modified Biberoglu and Behrman 4-point scale for pelvic pain recorded daily in an e-Diary.
  • Change From Parent Study Baseline In The Mean Dyspareunia Functional Impairment At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using the subject-modified Biberoglu and Behrman 5-point scale for dyspareunia recorded daily in an e-Diary.
  • Change From Parent Study Baseline In Patient Global Assessment (PGA) For Function At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    The PGA for function is a 1-item questionnaire designed to assess participant's impression of how their pain affected their usual activities.
  • Change From Parent Study Baseline In PGA For Pain At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    The PGA for function is a 1-item questionnaire designed to assess participant's impression of the severity of their pain.
  • Proportion Of Responders Based On Their EHP-30 Pain Domain Score At Week 52 And Week 104 [ Time Frame: Week 52 and Week 104 ]
    Assessed using the Pain Domain of the EHP-30 questionnaire.
  • Change From Parent Study Baseline In Each Of The Non-Pain EHP-30 Domains (Control And Powerlessness, Social Support, Emotional Well-Being, And Self-Image) At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed using EHP-30 questionnaire.
  • Percent Change From Parent Study Baseline In Bone Mineral Density At Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Assessed by dual-energy X-ray absorptiometry (DXA) scan.
  • Change From Parent Study Baseline In Predose Serum Concentrations Of Estradiol At Week 52 And Week 104 [ Time Frame: Parent Study Baseline, Week 52 and Week 104 ]
    Blood samples will be collected from participants for estradiol measurements.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • 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 participant's 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 participant's 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 participant's 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 participant's 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).
Detailed Description

This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible participants 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 participants will receive relugolix 40 mg orally once daily co-administered with low-dose E2 (1.0 mg) and NETA (0.5 mg) for 80 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 104 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose E2/NETA.

Baseline procedures for this extension study will be performed on the same day as the Week 24 Visit of the parent study. This visit, referred to as the "Week 24/Baseline Visit, will be defined as the date of completion of the last Week 24 procedure in the parent study. Participants 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 participant 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 80 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label extension
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: Relugolix
    Relugolix 40-mg tablet administered orally once daily
    Other Names:
    • TAK-385
    • MVT-601
  • Drug: Estradiol/norethindrone acetate
    Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
    Other Names:
    • E2/NETA
    • low-dose hormonal add-back
Study Arms  ICMJE Experimental: Relugolix plus E2/NETA
Relugolix co-administered with E2/NETA for 80 weeks.
Interventions:
  • Drug: Relugolix
  • Drug: Estradiol/norethindrone acetate
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
Actual Enrollment  ICMJE
 (submitted: June 16, 2020)
803
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2018)
800
Estimated Study Completion Date  ICMJE December 6, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102.
  2. Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame.
  3. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these.

Key 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. Has any chronic pain or frequently recurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for ≥ 7 days per month.
  3. Has a Z-score < -2.0 or has a ≥ 7% decrease in bone mineral density from the parent study Baseline at lumbar spine, total hip, or femoral neck based on the parent study Week 24 DXA assessment of bone mineral density.
  4. Has any contraindication to treatment with low-dose E2 and NETA, including:

    1. Known, suspected, or history of breast cancer;
    2. Known or suspected estrogen-dependent neoplasia;
    3. Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit;
    4. History of or active arterial thromboembolic disease, including stroke and myocardial infarction;
    5. Known anaphylactic reaction or angioedema or hypersensitivity to E2 or NETA;
    6. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden;
    7. Migraine with aura;
    8. History of porphyria.
  5. Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or, if available, any subsequent visit in one of the parent studies (MVT-601-3101 or MVT-601-3102):

    1. Alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN); or
    2. Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 51 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czechia,   Finland,   Georgia,   Hungary,   Italy,   New Zealand,   Poland,   Portugal,   Romania,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries Sweden
 
Administrative Information
NCT Number  ICMJE NCT03654274
Other Study ID Numbers  ICMJE MVT-601-3103
2017-004066-10 ( EudraCT Number )
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 Myovant Sciences GmbH
Study Sponsor  ICMJE Myovant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Myovant Medical Monitor Myovant Sciences
PRS Account Myovant Sciences GmbH
Verification Date August 2020

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