SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Women's Studies, Endometriosis |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 51 |
| Updated: | 1/20/2019 |
| Start Date: | May 22, 2018 |
| End Date: | March 31, 2022 |
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 104
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).
mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 104
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 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
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 80 weeks.
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 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
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 80 weeks.
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).
We found this trial at
2
sites
Click here to add this to my saved trials
