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NCT04978688 · ClinicalTrials.gov registry record · Phase 1
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
A Phase 1 study of Healthy, sponsored by Myovant Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04978688 is a Phase 1 study of Healthy that has completed, run by Myovant Sciences. The registered enrollment target is 48 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04978688, a Phase 1 study of Healthy, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Relugolix
- DRUG E2/NETA
Study Locations (1)
Minnesota
- Clinical Study Site - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2016-06-16 |
| Est. Completion | 2016-09-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04978688
The ClinicalTrials.gov registry entry for NCT04978688 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The listed sponsor is Myovant Sciences, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Relugolix is the first listed.
NCT04978688 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT04978688 about?
NCT04978688 is a clinical study titled "Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants". 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) end...
What is the current status of trial NCT04978688?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2016-06-16. Estimated completion is 2016-09-21.
What conditions does trial NCT04978688 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04978688?
The interventions under investigation include: Relugolix (DRUG), E2/NETA (DRUG).
Who is sponsoring clinical trial NCT04978688?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04978688 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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