Trials / Completed
CompletedNCT04978688
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
A Randomized Open Label Study to Evaluate the Safety, PK, and PD of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy for 6 Weeks in Healthy Premenopausal Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Myovant Sciences GmbH · Industry
- Sex
- Female
- Age
- 18 Years – 48 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Relugolix | Administered as an oral tablet once daily. |
| DRUG | E2/NETA | Administered as an oral tablet once daily. |
Timeline
- Start date
- 2016-06-16
- Primary completion
- 2016-09-21
- Completion
- 2016-09-21
- First posted
- 2021-07-27
- Last updated
- 2021-07-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04978688. Inclusion in this directory is not an endorsement.