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NCT02364882 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by Strategic Science & Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02364882: Completed Phase 1 study, sponsored by Strategic Science & Technologies.
NCT02364882 is a Phase 1 study that has completed, run by Strategic Science & Technologies. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02364882, a Phase 1 study, has completed, sponsored by Strategic Science & Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
• Occurrence of vulvar-vaginal reactions documented on the vaginal safety questionnaire By Berger Bowman rating and AEs
Interventions
- DRUG Sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT02364882 record still lists
NCT02364882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Sildenafil is the first listed.
NCT02364882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02364882 about?
NCT02364882 is a clinical study titled "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". 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 (...
What is the current status of trial NCT02364882?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2015-01. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02364882?
The interventions under investigation include: Sildenafil (DRUG).
Who is sponsoring clinical trial NCT02364882?
This trial is sponsored by Strategic Science & Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02364882's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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