NCT00814632

CC-10004 For The Treatment Of Vulvodynia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Kenneth Peters, MD · Academic / Other
• Sex: Female
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

CC-10004 is a well-tolerated, selective PDE4 inhibitor with a demonstrated inhibitory effect on inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions. This is an open-label, one arm, phase II study at William Beaumont Hospital. Twenty female subjects aged 18 or older meeting criteria for diagnosis of vulvodynia or vulvar vestibulitis (vestibulodynia) will be treated with CC-10004 at 20mg orally twice a day for 12 weeks.The patient will be seen for a total of ten visits by the study coordinator.

Conditions

• Vulvodynia

Interventions

Type	Name	Description
DRUG	CC-10004	CC-10004 20 mg. twice a day for 12 weeks

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2008-12-25
• Last updated: 2015-08-13
• Results posted: 2014-09-29

Locations

1 site across 1 country: United States