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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 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.

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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.

Conditions Studied

Interventions

  • DRUG CC-10004

Study Locations (1)

Michigan

  • William Beaumont Hospital - Royal Oak

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2008-12
Est. Completion 2011-02
Phase Phase 2

Sponsor

Kenneth Peters, MD

14 total trials

What the Registry Record Tells You About NCT00814632

The ClinicalTrials.gov registry entry for NCT00814632 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 137-participant average among 9 other Vulvodynia trials with a reported enrollment target (93% lower). The listed sponsor is Kenneth Peters, MD, which has 14 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.