NCT04948151

Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female Sexual Arousal Disorder

A Phase 2b, Multi-Center, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sildenafil Cream, 3.6% in Premenopausal Patients With Female Sexual Arousal Disorder (FSAD)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Strategic Science & Technologies, LLC · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study is looking to minimize side effects, while maintaining and potentially improving the therapeutic benefit to patients suffering from Female Sexual Arousal Disorder by providing a topical preparation of Sildenafil locally to the vulvar-vaginal tissue.

Conditions

• Female Sexual Arousal Disorder

Interventions

Type	Name	Description
DRUG	Sildenafil	Patients will apply 2-gram applications up to 9 times per month.
DRUG	Placebo	Patients will apply 2-gram applications up to 9 times per month

Timeline

• Start date: 2021-06-28
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2021-07-01
• Last updated: 2021-07-01

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study