Extension study to evaluate the efficacy and safety 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 - SPIRIT EXTENSION

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004066-10-ES

Enrollment

800

Registered

2018-06-04

Start date

2018-08-01

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Product Name: Relugolix Product Code: TAK-385, RVT-601 Pharmaceutical Form: Tablet INN or Proposed INN: RELUGOLIX CAS Number: 737789-87-6 Current Sponsor code: MVT-601 Other descriptive name: TAK-385

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Completed 24 weeks of study drug treatment and study participation in either MVT-601-3101 or MVT-601-3102; 2. Has voluntarily signed and dated the informed consent form prior to initiation of any study-specific procedures for MVT-601-3103; Note: Procedures conducted as part of the parent study that also serve as baseline procedures for this study will be done under the informed consent for the parent study. 3. 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 patient does not desire such treatment during this time frame; 4. Has a negative urine pregnancy test at the Week 24/Baseline visit; 5. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these; 6. Agrees to continue to use acceptable nonhormonal contraceptive methods as described in Section 4.6 consistently during the Open-Label Treatment Period and for at least 30 days after the last dose of study drug. However, the patient is not required to use the specified nonhormonal contraceptive methods if she: a. Has a sexual partner(s) who was vasectomized at least 6 months prior to the Week 24/Baseline visit; b. Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 6 months prior to the Week 24/Baseline visit (patients with Essure must have prior confirmation of tubal occlusion by hysterosalpingogram) and there must be no evidence of post-Essure syndrome; c. Has a nonhormonal intrauterine device (eg, Paragard®) placed in the uterus; d. Is not sexually active with men; periodic sexual relationship(s) with men requires the use of nonhormonal contraception as noted above; e. Practices total abstinence from sexual intercourse, as her preferred lifestyle; periodic abstinence is not acceptable. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion Criteria: None of the following criteria may be true for a patient to be eligible for enrollment into this study. 1. Has had a surgical procedure for treatment of 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 weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur (eg, bilateral hip replacement, spinal hardware in the lumbar spine); 4. Has a Z-score 2.0 times the upper limit of normal (ULN); or b. Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome); 10. Is currently pregnant or lactating, or intends to become pregnant during the study period or within 1 month after the last dose of study drug, or plans to donate ova during the study period or within 2 months after the last dose of study drug; 11. The presenting visual acuity score has decreased by 10 or more points at the Week 24/Baseline visit relative to the parent study Baseline visit; Note: Visual acuity score must have been obtained with corrective lenses, if applicable. 12. Is inappropriate for participation in this study because of conditions that may interfere with interpretation of study results or prevent the patient from complying with study requirements, as determined by the investigator, sub-investigator, or medical monitor; 13. Met a withdrawal criterion in the parent study (MVT-601-3101 or MVT-601-3102).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate long-term efficacy of relugolix 40 mg once daily co administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT 601-3102), on endometriosis-associated pain.;Secondary Objective: To evaluate long-term efficacy of relugolix 40 mg once daily co administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies MVT-601-3101 or MVT 601-3102, on the following: - Function, as measured by the EHP-30 Pain Domain; - Dysmenorrhea, as measured by the NRS for dysmenorrhea; - PGIC for dysmenorrhea; - NMPP, as measured by the NRS for NMPP; - PGIC for NMPP; - Dyspareunia, measured by the NRS; - PGIC for dyspareunia; - Dyspareunia-related functional effects (sB&B); - PGA for pain; - PGA for function; - Endometriosis-associated quality of life, as measured by the EHP-30 Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image domains; - Dysmenorrhea-related functional effects (sB&B); - NMPP-related functional effects (sB&B).;Primary end point(s): Primary Efficacy Endpoints - Proportion of women who respond or maintain response at Week 52/Early Termination, based on their dysmenorrhea NRS scores; - Proportion of women who respond or maintain response at Week 52/Early Termination, based on their NMPP NRS scores.;Timepoint(s) of evaluation of this end point: Week 52 (week 28 considering the extension study alone)/Early Termination.	—

Measure

Time frame

Main Objective: To evaluate long-term efficacy of relugolix 40 mg once daily co administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT 601-3102), on endometriosis-associated pain.;Secondary Objective: To evaluate long-term efficacy of relugolix 40 mg once daily co administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies MVT-601-3101 or MVT 601-3102, on the following: - Function, as measured by the EHP-30 Pain Domain; - Dysmenorrhea, as measured by the NRS for dysmenorrhea; - PGIC for dysmenorrhea; - NMPP, as measured by the NRS for NMPP; - PGIC for NMPP; - Dyspareunia, measured by the NRS; - PGIC for dyspareunia; - Dyspareunia-related functional effects (sB&B); - PGA for pain; - PGA for function; - Endometriosis-associated quality of life, as measured by the EHP-30 Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image domains; - Dysmenorrhea-related functional effects (sB&B); - NMPP-related functional effects (sB&B).;Primary end point(s): Primary Efficacy Endpoints - Proportion of women who respond or maintain response at Week 52/Early Termination, based on their dysmenorrhea NRS scores; - Proportion of women who respond or maintain response at Week 52/Early Termination, based on their NMPP NRS scores.;Timepoint(s) of evaluation of this end point: Week 52 (week 28 considering the extension study alone)/Early Termination.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Efficacy Endpoints - Change from the parent study Baseline to Week 52 in the EHP-30 Pain Domain scores; - Change from the parent study Baseline to Week 52/end of treatment (EOT) in the mean dysmenorrhea NRS score; - Proportion of patients who are better or much better on the PGIC for dysmenorrhea at Week 52/EOT; - Change from the parent study Baseline to Week 52/EOT in the mean NMPP NRS score; - Proportion of patients who are better or much better on the PGIC for NMPP at Week 52/EOT; - Change from the parent study Baseline to Week 52/EOT in the mean dyspareunia NRS scores; - Proportion of patients who are better or much better on the PGIC for dyspareunia at Week 52/EOT; - Change from the parent study Baseline to Week 52/EOT in the mean dyspareunia functional impairment on the sB&B scale; - Change from the parent study Baseline to Week 52/EOT in severity scores on the PGA for pain; - Proportion of responders at Week 52/EOT based on their EHP-30 Pain Domain score; - Change from the parent study Baseline to Week 52/EOT in function impairment on the PGA for function; - Change from the parent study Baseline to Week 52/EOT in each of the non-pain EHP-30 domains (Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image); - Change from the parent study Baseline pain assessment period to Week 52/EOT in dysmenorrhea-related functional effects (sB&B); - Change from the parent study Baseline pain assessment period to Week 52/EOT in NMPP-related functional effects (sB&B). Safety Endpoints - Incidence of adverse events; - Percent change from the parent study Baseline to Week 52 in bone mineral density at the lumbar spine (L1-L4), femoral neck, and total hip as assessed by DXA. Pharmacodynamic Endpoint: - Change from parent study Baseline to Week 52 in pre-dose concentrations of serum estradiol. Exploratory Endpoints - Change from Baseline to Week 52/EOT in the EHP-30 scale total score; - Change from Baseline to Week 52/EOT	—

Measure

Time frame

Secondary end point(s): Secondary Efficacy Endpoints - Change from the parent study Baseline to Week 52 in the EHP-30 Pain Domain scores; - Change from the parent study Baseline to Week 52/end of treatment (EOT) in the mean dysmenorrhea NRS score; - Proportion of patients who are better or much better on the PGIC for dysmenorrhea at Week 52/EOT; - Change from the parent study Baseline to Week 52/EOT in the mean NMPP NRS score; - Proportion of patients who are better or much better on the PGIC for NMPP at Week 52/EOT; - Change from the parent study Baseline to Week 52/EOT in the mean dyspareunia NRS scores; - Proportion of patients who are better or much better on the PGIC for dyspareunia at Week 52/EOT; - Change from the parent study Baseline to Week 52/EOT in the mean dyspareunia functional impairment on the sB&B scale; - Change from the parent study Baseline to Week 52/EOT in severity scores on the PGA for pain; - Proportion of responders at Week 52/EOT based on their EHP-30 Pain Domain score; - Change from the parent study Baseline to Week 52/EOT in function impairment on the PGA for function; - Change from the parent study Baseline to Week 52/EOT in each of the non-pain EHP-30 domains (Control and Powerlessness, Social Support, Emotional Well-Being, and Self-Image); - Change from the parent study Baseline pain assessment period to Week 52/EOT in dysmenorrhea-related functional effects (sB&B); - Change from the parent study Baseline pain assessment period to Week 52/EOT in NMPP-related functional effects (sB&B). Safety Endpoints - Incidence of adverse events; - Percent change from the parent study Baseline to Week 52 in bone mineral density at the lumbar spine (L1-L4), femoral neck, and total hip as assessed by DXA. Pharmacodynamic Endpoint: - Change from parent study Baseline to Week 52 in pre-dose concentrations of serum estradiol. Exploratory Endpoints - Change from Baseline to Week 52/EOT in the EHP-30 scale total score; - Change from Baseline to Week 52/EOT

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Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Finland, Georgia, Germany, Hungary, Italy, New Zealand, Poland, Portugal, Romania, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States

Contacts

Public ContactLeonid Katz, M.D.Medical Monitor

Myovant Sciences GmbH

leonid.katz@myovant.com+1(650)238-1837

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026