NCT02570282

Study to Evaluate the Efficacy and Safety of SST-6007, a Topical Sildenafil Cream, Compared to Placebo in Women With Female Sexual Arousal Disorder

A Phase 2A, Single-Dose, Double-Blind Placebo-Controlled, 2-Way Crossover Study to Evaluate the Efficacy and Safety of SST-6007, a Topical Sildenafil Cream, Compared to Placebo in Women With Female Sexual Arousal Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Strategic Science & Technologies, LLC · Industry
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A sufficient number of participants will be enrolled to yield 30 (approximately 15 pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3).

Detailed description

Participants will first complete a telephone screen (\< 28 days prior to Visit 1, Medical Screening) and will be scheduled for Visit 1 if eligible. After consent is obtained, study participants will undergo Visit 1 at a local gynecology clinic to determine their eligibility for continued study participation. If the participant meets all of the inclusion criteria and none of the exclusion criteria, they will be scheduled for Visit 2 and Visit 3 of the SST-6007/Placebo Double-Blind, Dosing Phase to be conducted at the Sexual Psychophysiology Laboratory at the University of Texas at Austin. Visit 2 must be within 5 (±2) days of Visit 1. One visit will evaluate the participant's response to SST-6007 and the other will evaluate the participant's response to placebo cream, using the VPP, the Arousometer, and neutral-erotic film presentations. The sequence of dosing will be randomly assigned (i.e., placebo cream then SST-6007 or SST-6007 then placebo cream) according to a computer-generated, randomization. There will be a 4-8 day washout period between Visits 2 and 3. During each experimental session, physiological and subjective sexual arousal will be assessed simultaneously and continuously using the VPP and the Arousometer. Electrical activity of the heart will be assessed with an ECG. ECG data will be used to process the VPA data. Immediately following completion of each erotic film, subjective sexual arousal, subjective perception of genital arousal, and positive and negative affect will be evaluated using a self-report 7-point Likert Scale (Film Scale) and the Positive and Negative Affect Schedule (PANAS).

Conditions

• Sexual Arousal Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Approximately 50% of the cream is to be applied externally to the clitoris and labia minora and approximately 50% is to be applied intravaginally.
DRUG	SST-6007	SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-05-01
• Completion: 2017-07-01
• First posted: 2015-10-07
• Last updated: 2017-10-03

Locations

1 site across 1 country: United States