Novel Topical Therapies for the Treatment of Genital Pain
Summary
This study is testing drugs not previously used topically for the treatment of vulvodynia, a common genital pain syndrome. It is hoped that one of these drugs will improve vaginal entryway pain with touch, daily pain scores and sexual functioning.
Timeline
- Start
- 2013-11
- Primary completion
- 2015-06
- Completion
- 2015-06
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Medications vs Placebo; p = 0.30; t-test, 2 sided NCT02099006 ↗
registry analysis (superiority or other test); Medications vs Placebo; p = 0.33; t-test, 2 sided NCT02099006 ↗
registry analysis (superiority or other test); Medications vs Placebo; p = 0.65; t-test, 2 sided NCT02099006 ↗
registry analysis (superiority or other test); Medications vs Placebo; p = 0.25; t-test, 2 sided NCT02099006 ↗
registry analysis (superiority or other test); Medications vs Placebo; p = 1.0; t-test, 2 sided NCT02099006 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amitriptyline | Small molecule | 2 % | Topical |
| Subject | Baclofen | Small molecule | 2 % | Topical |
| Subject | Gabapentin | Unknown | 6 % | Topical |
| Subject | Ketamine | Small molecule | 10 % | Topical |
| Subject | Ketoprofen | Small molecule | 10 % | Topical |
| Subject | Loperamide | Small molecule | 5 % | Topical |