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NCT04714554 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men
A Phase 1 study, sponsored by Myovant Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT04714554 is a Phase 1 study that has completed, run by Myovant Sciences. The registered enrollment target is 43 participants.
The verdict
NCT04714554, a Phase 1 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a two-part, open-label, fixed-sequence, two-period crossover drug interaction study to assess the potential effects of erythromycin on the pharmacokinetics of relugolix, estradiol (E2), and norethindrone (NET) in healthy postmenopausal women (Part 1) and the pharmacokinetics of relugolix in healthy adult men (Part 2).
Interventions
- DRUG Relugolix
- DRUG Erythromycin
- DRUG Relugolix/E2/NETA FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2021-01-06 |
| Est. Completion | 2021-03-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04714554
The ClinicalTrials.gov registry entry for NCT04714554 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Myovant Sciences, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Relugolix is the first listed.
NCT04714554 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04714554 about?
NCT04714554 is a clinical study titled "A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men". This is a two-part, open-label, fixed-sequence, two-period crossover drug interaction study to assess the potential effects of erythromycin on the pharmacokinetics of relugolix, estradiol (E2), and norethindrone (NET) in healthy postmenopausal women (Part 1) and the pharmacokinetics of relugolix in ...
What is the current status of trial NCT04714554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2021-01-06. Estimated completion is 2021-03-29.
What interventions are being tested in trial NCT04714554?
The interventions under investigation include: Relugolix (DRUG), Erythromycin (DRUG), Relugolix/E2/NETA FDC (DRUG).
Who is sponsoring clinical trial NCT04714554?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
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