Novel Topical Therapies for the Treatment of Genital Pain | RxWiki

Novel Topical Therapies for the Treatment of Genital Pain

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Female Genital Diseases
Intervention	Drug: Amitriptyline Drug: Baclofen Drug: Ketoprofen Drug: Ketamine Drug: Loperamide Drug: Gabapentin Drug: placebo
Phase	Phase 2/Phase 3
Sponsor	University of Rochester
Responsible Party	University of Rochester
ClinicalTrials.gov Identifier	NCT02099006
First Received	March 25, 2014
Last Updated	March 30, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	March 25, 2014
Last Updated Date	March 30, 2014
Start Date	November 2013
Estimated Primary Completion Date	December 2014
Current Primary Outcome Measures	Reduction of genital pain. [Time Frame: 13 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Novel Topical Therapies for the Treatment of Genital Pain
Official Title	Novel Topical Therapies for the Treatment of Genital Pain
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 13 week period in the first phase of the study. The drugs are compounded by the University of Rochester research pharmacy and dispensed in 13 vials, one vial to be used each week. Patients and study personnel are blinded as to which drug is being used. 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.
Study Type	Interventional
Study Phase	Phase 2/Phase 3
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Female Genital Diseases
Intervention	Drug: Amitriptyline Topical application of the drug at a 2% concentration in combination with 2% Baclofen Other Names: ElavilDrug: Baclofen Used topically at 2% concentration in combination with 2% amitriptyline Other Names: LioresalDrug: Ketoprofen To be applied topically at a 10% concentration Other Names: Orudis Oruvail Nexcede Orudis KT Drug: Ketamine To be applied topically at a 10% concentration Other Names: KetalarDrug: Loperamide To be applied topically at a 5% concentration Other Names: Imodium Imotil Kaopectate Drug: Gabapentin To be applied topically at a 6% concentration Other Names: NeurontinDrug: placebo Compounding base to be used alone as a placebo Other Names: Cetaphil
Study Arm (s)	Experimental: Medications 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. Placebo Comparator: Placebo The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	30
Estimated Completion Date	December 2014
Estimated Primary Completion Date	December 2014
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: 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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02099006
Other Study ID Numbers	46905
Has Data Monitoring Committee	No
Information Provided By	University of Rochester
Study Sponsor	University of Rochester
Collaborators	Mae Stone Goode Foundation Grant
Investigators	Principal Investigator: Adrienne D Bonham, MD University of Rochester
Verification Date	March 2014

Locations[ + expand ][ + ]