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
Condition: Female Sexual Health
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)