Novel Topical Therapies for the Treatment of Genital Pain

NCT02099006 | Completed Phase 2 Results

• 1 other identifier: 46905
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Genital Diseases

Outcome Measures

Primary Outcomes (1)

• Reduction in Daily Genital Pain.

  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.

  13 weeks

Secondary Outcomes (1)

• Reduction in Tampon Test Pain

  13 weeks

Study Arms (2)

Medications

EXPERIMENTAL

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; Drug: Baclofen; Drug: Ketoprofen; Drug: Ketamine; Drug: Loperamide; Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

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

Interventions

Amitriptyline DRUG

Topical application of the drug at a 2% concentration in combination with 2% Baclofen

Also known as: Elavil

Medications

Baclofen DRUG

Used topically at 2% concentration in combination with 2% amitriptyline

Also known as: Lioresal

Medications

Ketoprofen DRUG

To be applied topically at a 10% concentration

Also known as: Orudis, Oruvail, Nexcede, Orudis KT

Medications

Ketamine DRUG

To be applied topically at a 10% concentration

Also known as: Ketalar

Medications

Loperamide DRUG

To be applied topically at a 5% concentration

Also known as: Imodium, Imotil, Kaopectate

Medications

Gabapentin DRUG

To be applied topically at a 6% concentration

Also known as: Neurontin

Medications

placebo DRUG

Compounding base to be used alone as a placebo

Also known as: Cetaphil

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The presence of a dermatologic or neurologic condition which is determined by the investigator to be the primary cause of the patient's pain.
• Allergy to any of the medications or the base itself.
• Gabapentin (NeurontinTM) Amitriptyline (ElavilTM) Nortriptyline (PamelorTM) Desipramine (NorpraminTM) Tramadol (UltramTM, ConZipTM, RybixTM, RysoltTM, Ultram ERTM) Pregabalin (LyricaTM) Baclofen

Sponsors & Collaborators

• University of Rochester: lead
• Mae Stone Goode Foundation: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Amitriptyline; Baclofen; Ketoprofen; Ketamine; Loperamide; bismuth subsalicylate; Gabapentin; cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenylpropionates; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amines; Cyclohexanecarboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The small number of patients recruited left this study underpowered to uncover significant effects with the medications studied.

Results Point of Contact

• Title: Adrienne Bonham MD
• Organization: University of Rochester

adrienne_bonham@urmc.rochester.edu

(585) 273-3314

Study Officials

• Adrienne D Bonham, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 15, 2016
• Results First Posted: July 15, 2016

Record last verified: 2016-07

Locations

US (1)