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Bremelanotide Brain Activity Study in Women With HSDD
NCT04179734Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2019
- Primary completion
- Oct 2020
- Countries
- 1
- Sponsor
- Imperial College Healthcare NHS Trust
- Modality
- Peptides, Small Molecules
- Drugs
- bremelanotide
- Conditions
- hypoactive sexual desire disorder (HSDD)
01
Overview
Phase 4, randomised, double-blind trial in hypoactive sexual desire disorder (HSDD) comparing Bremelanotide with Placebo (2 arms). Primary endpoint: Changes in Blood Oxygen Level Dependent Signal Change on Functional MRI at 15 months. Started Oct 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Bremelanotide
Bremelanotide 1.75 mg subcutaneous injection
Placebo
Matching placebo subcutaneous injection
03
Who it enrols
Premenopausal women 18+ with HSDD, stable relationship, normal menstrual cycles, right-handed, BMI 18-35. Excludes CV disease, uncontrolled HTN, pregnancy, prior Bremelanotide, sexual trauma, other FSD, and certain medications.
04
Endpoints
Primary
Changes in Blood Oxygen Level Dependent Signal Change on Functional MRI
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