Trial · Interventional
CompletedPhase 1Registry dataStudy to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 228 participants (actual)
- Sponsor
- AMAG Pharmaceuticals, Inc. · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 17 Jun 2019
- Primary completion
- 19 Jul 2019
- Completion
- 20 Jul 2019
- First posted
- 4 Jun 2019
- Last update posted
- 4 Apr 2022
- Conditions
- Nausea
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
NCT0397304717 Jun 2019 to 20 Jul 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- BremelanotideDrug
- ZofranDrug
- PlaceboDrug
Arms2
Placebo comparator
Group 1: BMT plus placebo
1 dose of BMT 1.75 mg via autoinjector plus placebo (dosed 30±5 minutes prior to BMT dosing) on Day 1.
Active comparator
Group 2: BMT plus Zofran
1 dose of BMT 1.75 mg via autoinjector plus Zofran 8 mg (dosed 30±5 minutes prior to BMT dosing) on Day 1.
Primary outcomes1
Outcomes the sponsor listed as primary.
Incidence of treatment-emergent nausea following BMT with or without concomitant use of Zofran.
Time frame · 2 Days
Registry description
Incidence of treatment-emergent nausea following a single dose of BMT 1.75 mg SC with or without concomitant use of Zofran.
Secondary outcomes(3)
Severity of nausea using a Visual Analog Scale
Time frame · 2 Days
Registry description
"Severity of Nausea Visual Analog Scale", where the range is 0 to 100 and a lower value represents a better outcome
Time to onset of nausea
Time frame · 2 Days
Registry description
The time to onset of nausea
Duration of nausea
Time frame · 2 Days
Registry description
The duration of nausea
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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