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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 2, 2007 | ||||||||
| Last Updated Date | May 2, 2008 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Complete resolution of vestibulitis. [ Time Frame: Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire and the Q-tip applicator for detection of vestibular sensitivity. ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00496184 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Safety of the Nifedipine treatment. [ Time Frame: Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire. ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis | ||||||||
| Official Title ICMJE | Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome | ||||||||
| Brief Summary | To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia). |
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| Detailed Description | 30 women aged 18-45 diagnosed with Provoked localized Vulvodynia will be included. 10 women will use topical Nifedipine cream 0.2% 4 times a day for 6 weeks (except for menstrual period). 10 other women will use topical Nifedipine cream 0.4% 4 times a day for 6 weeks (except for menstrual period). 10 women will be a control group and will use a placebo cream. The study will be randomized and double blind. Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment. A special detailed questionnaire has been prepared in three languages and will be used to compare dyspareunia and associate variables between the groups. The Q-tip tests will be performed and findings will be drawn in each examination. Differences between the groups will be examined, and uni- and multi-variate analysis will be performed. |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Nifedipine cream topical application | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Completion Date | May 2008 | ||||||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00496184 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 20050989 | ||||||||
| Study Sponsor ICMJE | Western Galilee Hospital-Nahariya | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Western Galilee Hospital-Nahariya | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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