NCT06116045

Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder

Phase 2 Clinical Study to Evaluate the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Gel Form Applied to Women with Sexual Arousal Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Biozeus Biopharmaceutical S.A. · Industry
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.

Detailed description

FSAD is defined as the recurrent inability to attain or maintain sufficient genital arousal during sexual activity. Therefore, a healthy blood flow is central to the physiological processes related to sexual arousal, leading to genital lubrication, warmth, and clitoral protrusion. The vasculature and blood flow in vaginal tissue can be compromised due to natural aging and various risk factors, including cigarette smoking, alcohol abuse, lack of exercise, high-fat diets, hypertension, hypercholesterolemia, and diabetes mellitus. All these risk factors and conditions are highly prevalent among women and can lead to FSAD. BZ371A offers a potential solution by increasing blood flow in genital tissue through its unique mechanism of action, thereby restoring vascular homeostasis and the physiological processes related to sexual arousal in women.

Conditions

• Female Sexual Arousal Disorder
• Female Sexual Dysfunction

Interventions

Type	Name	Description
DRUG	BZ371A 7.5 mg (1.5 ml)	7.5 mg gel
DRUG	BZ371A 5.0 mg (1.0 ml)	5.0 mg gel
DRUG	BZ371A 2.5 mg (0.5 ml)	2.5 mg gel
DRUG	Placebo (1.5 ml)	BZ371A-matched placebo
DRUG	Placebo (1.0 ml)	BZ371A-matched placebo
DRUG	Placebo (0.5 ml)	BZ371A-matched placebo

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-02-01
• Completion: 2025-03-31
• First posted: 2023-11-03
• Last updated: 2024-10-22

Locations

1 site across 1 country: Brazil