Working… Menu

Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004316
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 9, 2008
University of Pittsburgh
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:

OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis.

II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis.

III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin.

IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Vulvar Diseases Drug: capsaicin Phase 1 Phase 2

Detailed Description:

PROTOCOL OUTLINE: This is a randomized study. Patients with interstitial cystitis are randomly assigned to 1 of 3 pain control therapies.

The first group is treated with capsaicin. A second group is given individually titrated doses of capsaicin: the dose is increased as tolerated or until symptomatic response is acceptable. A control group receives a placebo. Therapy for all groups is administered intravesically every week for 5 weeks.

Patients with vulvar vestibulitis are randomly assigned to 1 of 2 pain control therapies. One group applies topical capsaicin cream to the painful area 4 times a day for 6 weeks. The dose is individually titrated if burning discomfort persists and the patient is compliant with the application schedule. The control group applies a placebo.

Patients with vulvar vestibulitis may continue or cross to capsaicin for 6 additional weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 139 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : June 1995
Actual Primary Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


--Disease Characteristics-- Women with interstitial cystitis by National Institute of Diabetes and Digestive and Kidney Diseases criteria Vulvar vestibulitis by International Society for the Study of Vulvar Disease, i.e.: Severe pain on touch or attempted entry of vagina Tenderness to pressure within the vulvar vestibule Vulvar erythema Duration of symptoms at least 6 months Absence of vulvovaginal infection, i.e.: No fungus No trichomonas No chlamydia No gonorrhea No "clue cells" in vaginal discharge

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 identifier (NCT number): NCT00004316

Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh
Layout table for investigator information
Study Chair: Hugh Flood University of Pittsburgh

Layout table for additonal information Identifier: NCT00004316     History of Changes
Other Study ID Numbers: 199/11835
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: September 9, 2008
Last Verified: September 2008
Keywords provided by Office of Rare Diseases (ORD):
interstitial cystitis
rare disease
renal and genitourinary disorders
vulvar vestibulitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystitis, Interstitial
Vulvar Vestibulitis
Vulvar Diseases
Urinary Bladder Diseases
Urologic Diseases
Genital Diseases, Female
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs