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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

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Endometriosis Related Pain Drug: Relugolix Drug: Estradiol/norethindrone acetate Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label extension
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Bone Mineral Density (BMD) [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

  14. 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.

  15. Serum concentrations of estradiol [ Time Frame: up to 52 weeks ]
    Blood samples will be collected from participants for estradiol measurements.



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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT03654274


Locations
United States, Arizona
Tuscon
Tucson, Arizona, United States, 85712
United States, Tennessee
Chattanooga
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
Myovant Sciences GmbH

Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03654274     History of Changes
Other Study ID Numbers: MVT-601-3103
2017-004066-10 ( EudraCT Number )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Myovant Sciences GmbH:
Endometriosis, Pain, Dysmenorrhea

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral