Novel Topical Therapies for the Treatment of Genital Pain

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