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 Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
Intimmedicine Specialists
🇺🇸Washington, District of Columbia, United States
Southern Institute for Women's Sexual Health
🇺🇸Covington, Louisiana, United States
Clinical Neuroscience Solutions-Orlando
🇺🇸Jacksonville, Florida, United States
Suncoast Clinical Research - Pasco County
🇺🇸New Port Richey, Florida, United States
Healthcare Clinical Data, Inc.
🇺🇸North Miami, Florida, United States
CNS Healthcare
🇺🇸Orlando, Florida, United States
Clinical Neuroscience Solutions - Memphis
🇺🇸Memphis, Tennessee, United States
Women's OB-GYN, P.C. dba Saginaw Valley Medical
🇺🇸Saginaw, Michigan, United States
Women's Health Research Center
🇺🇸Lawrenceville, New Jersey, United States
The Center for Specialized Women's Health
🇺🇸Morristown, New Jersey, United States
Medical Research Center of Memphis
🇺🇸Memphis, Tennessee, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
AMR Fort Myers
🇺🇸Fort Myers, Florida, United States
Comprehensive Clinical Research, LLC
🇺🇸West Palm Beach, Florida, United States
Rosemark Women Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
New Age Medical Research Corporation
🇺🇸Miami, Florida, United States
Collaborative Neuroscience Network
🇺🇸Garden Grove, California, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Praetorian Pharmaceutical Research
🇺🇸Marrero, Louisiana, United States
Velocity Clinical Research, Providence
🇺🇸Warwick, Rhode Island, United States
TMC Life Research
🇺🇸Houston, Texas, United States
Medical Center for Clinical Research - San Diego
🇺🇸San Diego, California, United States
Precision Clinical Trials-Arizona
🇺🇸Phoenix, Arizona, United States
Essential Women's Health Associates
🇺🇸Las Vegas, Nevada, United States
Office of Doctor Rex G. Mabey Junior
🇺🇸Las Vegas, Nevada, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Rivus Wellness & Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Downtown Women's Healthcare
🇺🇸Denver, Colorado, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Omaha OB GYN Associates, P.C.
🇺🇸Omaha, Nebraska, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Coastal Clinical Research
🇺🇸Mobile, Alabama, United States
Visions Clinical Research -Tucson
🇺🇸Tucson, Arizona, United States
NRC Research Institute
🇺🇸Orange, California, United States
Cypress Medical Research Center
🇺🇸Wichita, Kansas, United States
AGILE Clinical Research Trials
🇺🇸Atlanta, Georgia, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Suffolk Obstetrics and Gynecology
🇺🇸Port Jefferson, New York, United States
Aventiv Research, inc.
🇺🇸Columbus, Ohio, United States
New Jersey Urology - Bloomfield
🇺🇸Millburn, New Jersey, United States
Velocity Clinical Research - Cleveland (Rapid Medical Research)
🇺🇸Cleveland, Ohio, United States
University Hospitals Landerbrook
🇺🇸Mayfield Heights, Ohio, United States
Urology Associates - Nashville
🇺🇸Nashville, Tennessee, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Seattle Women's Health Research - Gynecology
🇺🇸Seattle, Washington, United States
Tidewater Clinical Research
🇺🇸Norfolk, Virginia, United States
Maximos Obstetrics and Gynecology
🇺🇸League City, Texas, United States