Novel Topical Therapies for the Treatment of Genital Pain (Topicals)
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|ClinicalTrials.gov Identifier: NCT02099006|
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : July 15, 2016
Last Update Posted : July 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Female Genital Diseases||Drug: Amitriptyline Drug: Baclofen Drug: Ketoprofen Drug: Ketamine Drug: Loperamide Drug: Gabapentin Drug: placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Novel Topical Therapies for the Treatment of Genital Pain|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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.
Topical application of the drug at a 2% concentration in combination with 2% Baclofen
Other Name: Elavil
Used topically at 2% concentration in combination with 2% amitriptyline
Other Name: Lioresal
To be applied topically at a 10% concentration
To be applied topically at a 10% concentration
Other Name: Ketalar
To be applied topically at a 5% concentration
To be applied topically at a 6% concentration
Other Name: Neurontin
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.
Compounding base to be used alone as a placebo
Other Name: Cetaphil
- Reduction in Daily Genital Pain. [ Time Frame: 13 weeks ]Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of "0" was defined as no pain and a score of "10" was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated.
- Reduction in Tampon Test Pain [ Time Frame: 13 weeks ]Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of "0" was defined as no pain, and a score of "10" was defined as worst imaginable pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099006
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Adrienne D Bonham, MD||University of Rochester|