Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female Sexual Arousal Disorder
- Registration Number
- NCT04948151
- Lead Sponsor
- Strategic Science & Technologies, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 440
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Cream Placebo - Sildenafil Cream, 3.6% Sildenafil -
- Primary Outcome Measures
Name Time Method SFQ28 (AS) - 28 Day Recall SFQ28 score at the end of the Single-Blind Placebo Run-In to the end of the 12-Week Double-blind Dosing period. Evaluating the efficacy of Sildenafil Cream, 3.6% measured by change from baseline to end of study in the Arousal-Sensation Domain of the SFQ28.
FSDS-DAO (Q14) - 28 Day Recall Q14 score at the end of the Single-Blind Placebo Run-In to the end of the 12-Week Double-blind Dosing period. Evaluating the efficacy of Sildenafil Cream, 3.6% measured by change from baseline to end of study in the score for feeling concerned by difficulties with sexual arousal - Item #14 only of the FSDS-DAO.
- Secondary Outcome Measures
Name Time Method Arousal Diary (SSE) measured by daily prompt within 24hrs after each sexual event during the Single-Blind Placebo Run-In compared to the last 4 weeks of the Double-Blind Dosing Period. Evaluating the efficacy of Sildenafil Cream, 3.6% measured by change from baseline to end of study in the number of Satisfactory Sexual Events, question #11 in teh ARousal Diary.
Trial Locations
- Locations (51)
Coastal Clinical Research
🇺🇸Mobile, Alabama, United States
Precision Clinical Trials-Arizona
🇺🇸Phoenix, Arizona, United States
Visions Clinical Research -Tucson
🇺🇸Tucson, Arizona, United States
Collaborative Neuroscience Network
🇺🇸Garden Grove, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Medical Center for Clinical Research - San Diego
🇺🇸San Diego, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Downtown Women's Healthcare
🇺🇸Denver, Colorado, United States
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
Intimmedicine Specialists
🇺🇸Washington, District of Columbia, United States
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