Novel Topical Therapies for the Treatment of Genital Pain
Novel Topical Therapies for the Treatment of Genital Pain
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.
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.
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:

 1. The presence of a dermatologic or neurologic condition which is determined by the
 investigator to be the primary cause of the patient's pain.

 2. Allergy to any of the medications or the base itself.

 3. 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