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

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Interstitial Cystitis; Vulvar Diseases

Intervention: capsaicin (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
Hugh Flood, Study Chair, Affiliation: University of Pittsburgh


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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.



- -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

Locations and Contacts

Additional Information

Starting date: June 1995
Last updated: September 8, 2008

Page last updated: August 20, 2015

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