A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy (SERENE)

  • End date
    Apr 21, 2025
  • participants needed
  • sponsor
    Myovant Sciences GmbH
Updated on 21 October 2022
regular menstrual cycles


The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.


This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [mg], estradiol [E2] 1 mg, and norethindrone acetate [NETA] 0.5 mg).

Condition Contraception
Treatment Relugolix Combination Therapy
Clinical Study IdentifierNCT04756037
SponsorMyovant Sciences GmbH
Last Modified on21 October 2022


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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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