CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
CC-10004drug
Likely dose
CC-10004 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00814632
NCT00814632Phase 2Completed

A Clinical Trial Of CC-10004 For The Treatment Of Vulvodynia

Kenneth Peters, MD·interventional·Posted Dec 25, 2008·Updated Aug 13, 2015

In Brief

A Phase 2 clinical trial evaluating CC-10004 for Vulvodynia. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of these factors may include altered immune response, infections, altered vaginal acid-base balance, allergic reactions and psychosexual disorders. Women are generally treated with medications such as anti-histamines, anti-depressants and anti-inflammatories, or with physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is utilized as a last resort.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvodynia
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2008
Enrollment StartDec 1, 2008
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.5 years ago

Interventions

CC-10004drug

CC-10004 20 mg. twice a day for 12 weeks