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NCT03973047 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
A Phase 1 study, sponsored by AMAG Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 228
- Enrollment target
NCT03973047: Completed Phase 1 study, sponsored by AMAG Pharmaceuticals.
NCT03973047 is a Phase 1 study that has completed, run by AMAG Pharmaceuticals. The registered enrollment target is 228 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (280% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03973047, a Phase 1 study, has completed, sponsored by AMAG Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 228 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.
Primary Outcome
Incidence of treatment-emergent nausea following a single dose of BMT 1.75 mg SC with or without concomitant use of Zofran.
Interventions
- DRUG Placebo
- DRUG Bremelanotide
- DRUG Zofran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2019-07-20 |
| Phase | Phase 1 |
What the finished NCT03973047 record still lists
NCT03973047 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (280% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03973047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03973047 about?
NCT03973047 is a clinical study titled "Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran". This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.
What is the current status of trial NCT03973047?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 228 participants. The study started on 2019-06-17. Estimated completion is 2019-07-20.
What interventions are being tested in trial NCT03973047?
The interventions under investigation include: Placebo (DRUG), Bremelanotide (DRUG), Zofran (DRUG).
Who is sponsoring clinical trial NCT03973047?
This trial is sponsored by AMAG Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03973047's enrollment target sits among peer trials
228 221st of 2000 higher than 1,780 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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