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Trial · Interventional

CompletedPhase 1Registry data

Study 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
20192020
  1. Ph 1

    Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran

    NCT03973047

    17 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.

  1. 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)
  1. 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

  2. Time to onset of nausea

    Time frame · 2 Days

    Registry description

    The time to onset of nausea

  3. 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
Key Inclusion Criteria: 1. Willing and able to provide written informed consent prior to participating in the study. 2. Female subjects ≥18 to 55 years of age (inclusive) and premenopausal as defined by the modified STRAW criteria (specifically, Stage -5 \[menses variable to regular\] through Stage 1 \[≥2 skipped cycles and an interval of amenorrhea ≥60 days\]). 3. Able to communicate clearly with the Principle Investigator (PI) and staff; able to read English, complete questionnaires, and understand study procedures. 4. Able to complete all screening period evaluations, stay in the clinic testing facility for minimum of 4 hours following dose of BMT. 5. In good general health, free from clinically significant medical or psychiatric illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG, and clinical laboratory tests). Key Exclusion Criteria: 1. Postmenopausal female, designated by having amenorrhea for ≥12 months. 2. Has current or recent (within 6 months) history of gastrointestinal disease, or any surgical or medical condition such as Crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drug. 3. Has any clinically significant medical condition, physical exam finding, or ECG abnormality, or clinically significant abnormal value for hematology, serology, clinical chemistry, or urinalysis at Screening, or at admission to the study center, as assessed by the PI. 4. Has any of the following: \- History or current diagnosis of uncontrolled hypertension defined as: Two (2) sequential assessments (at least 5 minutes apart and no more than 15 minutes apart) at levels \>140 mmHg SBP or 90 mmHg DBP and/or treatment for hypertension that has been changed at least once in the 4 weeks before Screening. \- Renal dysfunction (creatinine clearance \< 80 mL/min using Cockcroft Gault calculation). 5. History or presence of malignancy within the past 5 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.

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