NCT02364882

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Strategic Science & Technologies, LLC · Industry
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Subject eligibility will be determined through Screening evaluations. Screening evaluations will include a review of inclusion and exclusion criteria, medical and Ob-Gyn history; full physical and gynecological examinations (including vulvar-vaginal examination); Pap smear; vital signs (supine); orthostatic blood pressure and heart rate; laboratory assessments (chemistry, hematology, prothrombin time, FSH and urinalysis); concomitant medication use; electrocardiogram (ECG); serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, sexually transmitted infection (syphilis, gonorrhea, chlamydia), Herpes (HSV-2) and human immunodeficiency virus (HIV) antibodies; and urine drug screen. The Screening visit will occur up to 28 days before Day 1. For each dose level, safety from the first 2 subjects dosed will be evaluated prior to dosing the remainder of subjects at that dose level. If results indicate safety issues (defined as a known occurrence of an event of orthostatic hypotension (up to 8 hours post dose) and/or any score above 0 using the 4 point Vulvar-vaginal Irritation Scale in the first 2 subjects, an additional 2 subjects will be dosed and safety data evaluated. If no additional safety problems are found, the remaining subjects will be dosed at that level. If safety issues are found in the second 2 subjects dosed, no further dosing will occur and the prior dose level will be considered the maximum tolerated dose. In addition, any subject who experiences orthostatic hypotension at any point in the study or has a vulvar-vaginal irritation score above a 0 using the 4 point Vulvar-vaginal Irritation Scale at any dosing level will be withdrawn from the study and not proceed to the next level. An additional review of the safety data upon completion of dosing at each level will be done to determine if dose escalation is warranted. Safety decisions will be made by the Principal Investigator (PI) and the Medical Monitor based on their clinical judgment. The first day of dosing will be considered Day 1. Subjects will be housed in the clinic for the duration of each Treatment Period to allow for collection of the PK samples up to 32 hours post-dose and the completion of all discharge procedures.

Conditions

• Female Sexual Health

Interventions

Type	Name	Description
DRUG	Sildenafil

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-02-18
• Last updated: 2015-06-22

Locations

1 site across 1 country: United States