Sexual Arousal Disorder Clinical Trial
Official title:
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
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).
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).
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