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Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

NCT04179734 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-09

Study results available
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Summary

A randomised, double-blind, placebo-controlled, two-way crossover physiological study. Designed to evaluate the effects of melanocortin-4 receptor (MC4R) activation on brain activity patterns and behavioural psychometric measures of sexual arousal during visual erotic stimuli in approximately 40 right-handed, heterosexual, premenopausal women aged 18 years and over with Hypoactive Sexual Desire Disorder (HSDD) for at least a 6 month duration.

Conditions

  • Hypoactive Sexual Desire Disorder

Interventions

DRUG

Bremelanotide

Melanocortin-4 receptor agonist subcutaneous injection.

DRUG

Placebo

Placebo subcutaenous injection.

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Imperial College Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Waljit S Dhillo, MBBS PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2020-10-06
Completion
2020-10-06
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179734 on ClinicalTrials.gov