Novel Topical Therapies for the Treatment of Genital Pain
Condition: Female Genital Diseases
MeSH terms: Genital Diseases; Genital Diseases, Female
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Amitriptyline; Baclofen; Ketoprofen; Ketamine; Loperamide; Gabapentin; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Topical application of the drug at a 2% concentration in combination with 2% Baclofen; Used topically at 2% concentration in combination with 2% amitriptyline; To be applied topically at a 10% concentration; To be applied topically at a 10% concentration; To be applied topically at a 5% concentration; To be applied topically at a 6% concentration; Compounding base to be used alone as a placebo
Other intervention name(s): Elavil; Lioresal; Orudis; Oruvail; Nexcede; Orudis KT; Ketalar; Imodium; Imotil; Kaopectate; Neurontin; Cetaphil
Intervention MeSH terms: Ketoprofen; Ketamine; Gabapentin; Amitriptyline; Baclofen; Loperamide; Antidiarrheals
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment