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CC-10004 For The Treatment Of Vulvodynia
NCT00814632 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG CC-10004
Study Locations (1)
Michigan
- William Beaumont Hospital — Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00814632
The ClinicalTrials.gov registry entry for NCT00814632 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kenneth Peters, MD, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Vulvodynia appearing as the primary indexed condition, and to 1 intervention — of which CC-10004 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00814632 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00814632 about?
NCT00814632 is a clinical study titled "CC-10004 For The Treatment Of Vulvodynia". 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 a...
What is the current status of trial NCT00814632?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2008-12. Estimated completion is 2011-02.
What conditions does trial NCT00814632 study?
This clinical trial studies the following conditions: Vulvodynia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00814632?
The interventions under investigation include: CC-10004 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00814632?
This trial is sponsored by Kenneth Peters, MD, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00814632 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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