A Phase 1, Open-Label, Within-Subject Dose-Escalation Study to Evaluate the Clinical Vulvar-Vaginal Safety and Pharmacokinetic Profile of SST-6006, a Topical Sildenafil Cream (5% w/w), in Healthy Postmenopausal Women

NCT02364882 Phase 1 COMPLETED

This is a Phase 1, single center, open-label, within-subject dose-escalation study evaluating the safety and pharmacokinetics of SST-6006 in healthy postmenopausal women. Three dose levels of SST-6006 and a placebo regimen will be evaluated: 1 g (0 mg of sildenafil), 1 g (50 mg of sildenafil), 2 g (100 mg of sildenafil), and 4 g (200 mg of sildenafil). Doses will be administered sequentially and will be separated by a 14-16 day washout period. All 3 dose levels and the placebo will be applied both externally and internally.

Details

Lead sponsor	Strategic Science & Technologies, LLC
Phase	Phase 1
Status	COMPLETED
Enrolment	21
Start date	2015-01
Completion	2015-05

Conditions

• Female Sexual Health

Interventions

• Sildenafil

Primary outcomes

• Vaginal Irritation — 32 hours
  • Occurrence of vulvar-vaginal reactions documented on the vaginal safety questionnaire By Berger Bowman rating and AEs
• Orthostatic Hypotension — 32 Hours
  Vital sign measurement
• Incidence of AEs — 32 hours
  Adverse events, including occurrence of headache, orthostatic hypotension, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision (chromatopsia,increased sensitivity to light, blurred vision), diarrhea, dizziness, and rash

Countries

United States