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NCT00814632 · ClinicalTrials.gov registry record · Phase 2
CC-10004 For The Treatment Of Vulvodynia
A Phase 2 study of Vulvodynia, sponsored by Kenneth Peters, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00814632: Completed Phase 2 study of Vulvodynia, sponsored by Kenneth Peters, MD.
NCT00814632 is a Phase 2 study of Vulvodynia that has completed, run by Kenneth Peters, MD. The registered enrollment target is 10 participants, below the 137-participant average among 9 other Vulvodynia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00814632, a Phase 2 study of Vulvodynia, has completed, sponsored by Kenneth Peters, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: "As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1. The primary outcome showing response to trea
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 |
What the finished NCT00814632 record still lists
NCT00814632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 137-participant average among 9 other Vulvodynia trials with a reported enrollment target (93% lower).
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.
NCT00814632 reports a single indexed study location in Michigan.
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.
What interventions are being tested in trial NCT00814632?
The interventions under investigation include: CC-10004 (DRUG).
Who is sponsoring clinical trial NCT00814632?
This trial is sponsored by Kenneth Peters, MD, which has 14 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Vulvodynia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00814632's enrollment target sits among peer trials
10 9th of 9 higher than 1 of 9 other Vulvodynia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vulvodynia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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