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BZ371A for Female Sexual Arousal Disorder
NCT06116045Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2024
- Primary completion
- Feb 2025
- Countries
- 1
- Sponsor
- Biozeus
- Modality
- Small Molecules, Modified Peptides, Native Peptides
- Drugs
- bz371a
- Conditions
- female sexual arousal disorder (FSAD)
01
Overview
Phase 2, randomised, double-blind trial of bz371a in female sexual arousal disorder (FSAD) (6 arms), sponsored by Biozeus. Primary endpoint: Efficacy in increasing sexual arousal at 8 weeks. Started Oct 2024; status: recruiting.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Group A - BZ371A 7.5mg then Placebo
BZ371A 7.5mg (Period 1) -> Placebo (Period 2)
Group B - Placebo then BZ371A 7.5mg
Placebo (Period 1) -> BZ371A 7.5mg (Period 2)
Group C - BZ371A 5.0mg then Placebo
BZ371A 5.0mg (Period 1) -> Placebo (Period 2)
Group D - Placebo then BZ371A 5.0mg
Placebo (Period 1) -> BZ371A 5.0mg (Period 2)
Group E - BZ371A 2.5mg then Placebo
BZ371A 2.5mg (Period 1) -> Placebo (Period 2)
Group F - Placebo then BZ371A 2.5mg
Placebo (Period 1) -> BZ371A 2.5mg (Period 2)
03
Who it enrols
Women aged 21-60 with FSAD, in a stable relationship, willing to attempt sexual activity twice a week. Excludes uncontrolled diabetes, history of sexual trauma, gynecological cancer, and use of certain medications.
04
Endpoints
Primary
Efficacy in increasing sexual arousal
Secondary
Efficacy in increasing desire, lubrification, orgasm and arousal
Evaluation of the quality of female sexual encounters
Efficacy in increasing genital blood flow
Female Sexual Function Index
Assessment of treatment satisfaction
Adverse effects report
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