A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

Sponsor
Takeda
Study ID
NCT02655237
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relugolix — DRUG
    Relugolix tablets
  • Relugolix Placebo — DRUG
    Relugolix placebo-matching tablets
  • Leuprorelin — DRUG
    Leuprorelin injection
  • Leuprorelin Placebo — DRUG
    Leuprorelin placebo-matching injections

Study Details

The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously \[SC\]/time) in patients with uterine fibroids.

Key Dates

Start date
Mar 5, 2016
Status verified
Dec 2018
Primary completion
May 17, 2017
Completion
Sep 25, 2017

Study Design

Enrollment
281 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Relugolix 40 mg
    Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 3 to 6 weeks in run-in period followed by relugolix 40 mg, tablets, orally, once daily and leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 24 weeks in treatment period.
  • Active Comparator: Leuprorelin 1.88 mg or 3.75 mg
    Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 3 to 6 weeks in run-in period followed by leuprorelin acetate 1.88 mg or 3.75 mg, injection, SC, once in 4 weeks and relugolix placebo matching tablets, orally, once daily for 24 weeks in treatment period.

Primary Outcome Measure

Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12 [ Time Frame: Week 6 to 12 ]

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