Phase 2
N=9
CC-10004 For The Treatment Of Vulvodynia
Vulvodynia
Bottom Line
View on ClinicalTrials.gov: NCT00814632 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Global Response Assessment — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CC-10004 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kenneth Peters, MD
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Response Assessment |
5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participant must understand and voluntarily sign and date the appropriate Informed Consent document.
- Female who is ≥ 18 years of age and 9 g/dL
- Hematocrit ≥ 27%
- White blood cell (WBC) count ≥ 3000 /mL (≥ 3.0 X 109/L) and 3 years prior to entry must have been effectively treated.
- Positive TB skin test (Mantoux test)
- History of incompletely treated latent Mycobacterium tuberculosis infection as indicated by a positive positive Purified Protein Derivative [PPD] skin test or in vitro test [T-SPOT®. TB, QuantiFERON Gold®] or chest x-ray.
- Clinically significant abnormality on the chest x-ray (CXR) at screening.
- Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
- Any clinically significant abnormality on 12-lead ECG at screening
- Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening.
- History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
- History of a vestibulectomy
Data sourced from ClinicalTrials.gov (NCT00814632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.