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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004316
• Date of registration: 18/10/1999
• Prospective Registration: No
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
• Date of first enrolment: June 1995
• Target sample size: 139
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004316
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Contacts

• Name: Hugh Flood
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Interstitial Cystitis

Vulvar Diseases

Intervention(s)

Drug: capsaicin

Secondary ID(s)

199/11835

UPMC-950666

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Pittsburgh