Clinical trial NCT02099006
Conditions: Female Genital Diseases
Sponsor: University of Rochester
Start date: 2013-11-01; Completion date: 2015-06-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Detailed description:
Vulvodynia is defined as burning pain, occurring in the absence of any visible finding or a clinically identifiable nervous disorder. Current treatments include vulvar care measure, topical medications, oral medications, biofeedback, physical therapy and surgery. The usual treatment is to have the patient take either tricyclic antidepressants or anti convulsants orally, however these methods seldom bring total relief. These drugs do have significant side effects limiting the patient's tolerance of the higher does sometimes needed. An effective topical medication would greatly benefit these women with fewer side effects and better tolerance. Topical amitriptyline and baclofen are often prescribed, but no studies have been done to support their use. Topical gabapentin has also been shown to have good effect, but no prospective clinical study as been done.

This study will test topical application of Cetaphil, Loperamide, Gabapentin, Ketoprofen, Ketamine and Amitriptyline over a 19 week period in the first phase of the study. The drugs are compounded by the University of Rochester research pharmacy and dispensed in 19 vials, one vial to be used each week. Patients and study personnel are blinded as to which drug is being used. Each study participant was given a week of placebo at the initiation of the study. Each study compound, which contains both the drug and the base (Cetaphil) will be used twice a day for two weeks in a row, followed by a one week washout of base alone. If a patient finds that one of the drugs is effective she may stop participation after the first 13 weeks and request that the most effective drug be prescribed for her. The unblinding officer would then work with the research pharmacy to identify the effective drug and provide the patient with a prescription for that drug. If the patient desires, she may enroll in the second phase of the study when she will test the last two drugs over a six week period with the washout as in the first segment of the study. The drugs would be administered in vials as in the first section of the study.

Every week on Sunday the patient will complete an electronic diary, recording her daily pain, any drug side effects, pain with the tampon test and overall health. Every three weeks she will complete the Female Sexual Function Index on the same electronic system. She would start her new drug on Monday each week. Additionally the coordinator of the study will call each patient on Wednesday to see if they are having any problems with the drug started on Monday.

All patients who could become pregnant are required to maintain effective contraception throughout the study.

Arms: arm 1: Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study. arm 2: The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.
Interventions: intervention 1: Amitriptyline intervention 2: Baclofen intervention 3: Ketoprofen intervention 4: Ketamine intervention 5: Loperamide intervention 6: Gabapentin intervention 7: placebo
Intervention descriptions: intervention 1: Topical application of the drug at a 2% concentration in combination with 2% Baclofen intervention 2: Used topically at 2% concentration in combination with 2% amitriptyline intervention 3: To be applied topically at a 10% concentration intervention 4: To be applied topically at a 10% concentration intervention 5: To be applied topically at a 5% concentration intervention 6: To be applied topically at a 6% concentration intervention 7: Compounding base to be used alone as a placebo

Protocol documents: