Phase 3
N=9
Novel Topical Therapies for the Treatment of Genital Pain
Female Genital Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02099006 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Reduction in Daily Genital Pain. — 2.4; 2.92; 3.42; 2.77 units on a scale — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amitriptyline (Drug); Baclofen (Drug); Ketoprofen (Drug); Ketamine (Drug); Loperamide (Drug); Gabapentin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Daily Genital Pain. |
2.4; 2.92; 3.42; 2.77; 3.70; 3.41 | 0.30 |
| SECONDARY Reduction in Tampon Test Pain |
4.71; 5.29; 5.92; 5.92; 5.125; 4.875 | 0.31 |
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.
Eligibility Criteria
Inclusion Criteria
- Women between ages of 18 and 65 who complain of localized provoked vulvar pain and meet the criteria for the diagnosis of localized provoked vulvodynia. Patients who have failed or have been unable to tolerate previous attempts at systematic therapy or surgery will be specifically recruited.
Exclusion Criteria
- The presence of a dermatologic or neurologic condition which is determined by the investigator to be the primary cause of the patient's pain.
- Allergy to any of the medications or the base itself.
- Concurrent use of the following medications. . The patient may enroll in the study after a two week washout from these medications. Patients may need to receive approval from the prescribing physician before stopping these medications. Failure to obtain approval for medication cessation would be cause for exclusion.
Gabapentin (NeurontinTM) Amitriptyline (ElavilTM) Nortriptyline (PamelorTM) Desipramine (NorpraminTM) Tramadol (UltramTM, ConZipTM, RybixTM, RysoltTM, Ultram ERTM) Pregabalin (LyricaTM) Baclofen
Data sourced from ClinicalTrials.gov (NCT02099006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.