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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03751124
Other study ID # MVT-601-035
Secondary ID 2018-001368-43
Status Completed
Phase Phase 3
First received
Last updated
Start date October 16, 2018
Est. completion date November 18, 2021

Study information

Verified date April 2022
Source Myovant Sciences GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of < 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.


Description:

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Study Design


Intervention

Drug:
Relugolix
Relugolix 40 mg tablet administered orally once daily
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Placebo for relugolix
Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
Placebo for E2/NETA
Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor

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Sponsors (1)

Lead Sponsor Collaborator
Myovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Brazil,  Chile,  Czechia,  Hungary,  Italy,  Poland,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of women who maintain a menstrual blood loss (MBL) volume of < 80 mL MBL volume is measured using the alkaline hematin method. at Week 24 (Week 72 relative to the parent study baseline)
Secondary Proportion of women who maintain a MBL volume of < 80 mL MBL volume is measured using the alkaline hematin method. at Week 52 (Week 104 relative to the parent study baseline)
Secondary Change in MBL volume MBL volume is measured using the alkaline hematin method. from Baseline up to Week 52 (Week 104 relative to the parent study baseline)
Secondary Proportion of women who responded (MBL volume < 80 mL) to retreatment during retreatment period MBL volume is measured using the alkaline hematin method. at Week 52 (Week 104 relative to the parent study baseline)
Secondary Proportion of women with heavy menstrual bleeding Defined as the proportion of women with MBL volume of = 80 mL at any time. MBL volume is measured using the alkaline hematin method. at Week 24 and 52 (Week 72 and Week 104 relative to the parent study baseline)
Secondary Time to resumption of heavy menstrual bleeding Defined as time to MBL volume of = 80 mL. MBL volume is measured using the alkaline hematin method. up to Week 52 (Week 104 relative to the parent study baseline)
Secondary Proportion of women with suppression of bleeding Will be assessed using patient daily diary and MBL volume measured using the alkaline hematin method. at Week 24 and 52 (Week 72 and Week 104 relative to the parent study baseline)
Secondary Time to resumption of menses in women who are amenorrhoeic Will be assessed using patient daily diary. up to Week 52 (Week 104 relative to the parent study baseline)
Secondary Change in hemoglobin concentration Blood samples will be collected from participants for hemoglobin measurements. from Baseline up to Week 52 (Week 104 relative to the parent study baseline)
Secondary Change in impact on quality of life: UFS-QOL Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL) from Baseline up to Week 52 (Week 104 relative to the parent study baseline)
Secondary Change in Patient Global Assessment (PGA) for symptoms The PGA for symptoms is a 1-item questionnaire designed to assess participants impression of the severity of their symptoms related to uterine fibroids. from Baseline up to Week 52 (Week 104 relative to the parent study baseline)
Secondary Change in PGA for function The PGA for function is a 1-item questionnaire designed to assess participants impression of how their symptoms related to uterine fibroids affected their usual activities. from Baseline up to Week 52 (Week 104 relative to the parent study baseline)
Secondary Bone Mineral Density (BMD) Assessed by dual-energy X-ray absorptiometry (DXA) scan. from parent study Baseline up to Week 104
Secondary Percentage of participants with adverse events (AEs) as a measure of safety and tolerability Assessed by percentage of participants with AEs and serious AEs. up to 52 weeks
Secondary Serum estradiol concentrations Blood samples will be collected from participants for estradiol measurements. up to 52 weeks
See also
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