Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine cream topical application | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Complete resolution of vestibulitis. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the Nifedipine treatment. | Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire. |
Not provided
Inclusion Criteria:
Women diagnosed with vestibulitis according to Friedrich's criteria:
Non-pregnant women aged 18-45.
Women use effective contraception and are not interested in becoming pregnant during the study period.
No known Nifedipine allergy.
No medical diseases.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacob Bornstein, MD | Western Galilee Hospital, Nahariya, Israel | Principal Investigator |
| Doron Zarfati, MD | Western Galilee Hospital, Nahariya, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital | Nahariya | Israel | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12192883 | Background | Walsh KE, Berman JR, Berman LA, Vierregger K. Safety and efficacy of topical nitroglycerin for treatment of vulvar pain in women with vulvodynia: a pilot study. J Gend Specif Med. 2002 Jul-Aug;5(4):21-7. | |
| 14583976 | Background | Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2003;(4):CD003431. doi: 10.1002/14651858.CD003431. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Department of Obstetrics and Gynecology |
| Nahariya |
| Israel |
| 10912437 | Background | Bornstein J, Zarfati D, Goldik Z, Abramovici H. Vulvar vestibulitis: physical or psychosexual problem? Obstet Gynecol. 1999 May;93(5 Pt 2):876-80. doi: 10.1016/s0029-7844(98)00535-3. |
| D000091662 | Genital Diseases |