Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Myovant Sciences GmbH
Study ID
NCT04978688
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 48 Years
Healthy Volunteers
Accepted

Interventions

  • Relugolix — DRUG
    Administered as an oral tablet once daily.
  • E2/NETA — DRUG
    Administered as an oral tablet once daily.

Study Details

This was a randomized, open-label, repeat dose study of once daily relugolix alone or relugolix combined with hormonal add-back therapy (combination estradiol/norethindrone acetate) (E2/NETA) to assess safety, including markers of bone resorption, pharmacokinetics (PK), and pharmacodynamics (PD) endpoints.

Key Dates

Start date
Jun 16, 2016
Status verified
Jul 2021
Primary completion
Sep 21, 2016
Completion
Sep 21, 2016

Study Design

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

Arms

  • Experimental: Relugolix
    Participants received relugolix 40 milligrams (mg) alone for 6 weeks.
  • Experimental: Relugolix + E2/NETA
    Participants received relugolix 40 mg and E2/NETA at 1 mg/ 0.5 mg for 6 weeks.

Primary Outcome Measure

PK: Area Under The Concentration-Time Curve From Time Zero To Hour 24 (AUC0-24) Of Relugolix, E2, Estrone (El), Ethinylestradiol (EE), NETA [ Time Frame: Predose and up to 24 hours at Weeks 3 and 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Study SiteMinneapolisMinnesota55404-

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Clinical Study Site· Minneapolis, MN

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