A Randomized Clinical Trial for Women With Vulvodynia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00607490 |
Recruitment Status
:
Completed
First Posted
: February 5, 2008
Last Update Posted
: May 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vulvodynia | Behavioral: Cognitive-Behavioral Therapy Behavioral: Supportive Psychotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial |
Study Start Date : | September 2000 |
Actual Primary Completion Date : | March 2005 |
Actual Study Completion Date : | March 2005 |
Arm | Intervention/treatment |
---|---|
Experimental: Cognitive-behavioral Therapy
10 weekly individual 60-minute sessions
|
Behavioral: Cognitive-Behavioral Therapy
Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
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Active Comparator: Supportive Psychotherapy
10 weekly individual 60-minute sessions
|
Behavioral: Supportive Psychotherapy
Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
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- Pain Severity [ Time Frame: Measured at 1-year follow-up ]
- Sexual Functioning [ Time Frame: Measured at 1-year follow-up ]
- Emotional Functioning [ Time Frame: Measured at 1-year follow-up ]

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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Independently diagnosed with vulvodynia by two study physicians
Exclusion Criteria:
- Any conditions known to better account for the vulvar pain
- Psychotic illness
- Actively suicidal
- Substance dependent
- Life-threatening illness
- Initiated psychotherapy, psychopharmacologic treatment or pain medication within one month prior to beginning the assessment phase of the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607490
Principal Investigator: | Robin M Masheb, Ph.D. | Yale University |
Responsible Party: | Robin Masheb, Yale University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00607490 History of Changes |
Other Study ID Numbers: |
R01HD038493 ( U.S. NIH Grant/Contract ) |
First Posted: | February 5, 2008 Key Record Dates |
Last Update Posted: | May 23, 2016 |
Last Verified: | January 2008 |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Vulvodynia Vulvar pain Dyspareunia Sexual dysfunction Vestibulitis |
Additional relevant MeSH terms:
Vulvodynia Vulvar Diseases Genital Diseases, Female |