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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
Sponsor:
Collaborator:
Mae Stone Goode Foundation
Information provided by (Responsible Party):
Adrienne Bonham, University of Rochester

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Drug: Amitriptyline
Topical application of the drug at a 2% concentration in combination with 2% Baclofen
Other Name: Elavil

Drug: Baclofen
Used topically at 2% concentration in combination with 2% amitriptyline
Other Name: Lioresal

Drug: 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 Name: Ketalar

Drug: 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 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.
Drug: placebo
Compounding base to be used alone as a placebo
Other Name: Cetaphil




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Mae Stone Goode Foundation
Investigators
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Principal Investigator: Adrienne D Bonham, MD University of Rochester

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Responsible Party: Adrienne Bonham, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02099006     History of Changes
Other Study ID Numbers: 46905
First Posted: March 28, 2014    Key Record Dates
Results First Posted: July 15, 2016
Last Update Posted: July 15, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Genital Diseases, Female
Ketoprofen
Ketamine
Gabapentin
Amitriptyline
Amitriptyline, perphenazine drug combination
Loperamide
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Antimanic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors