NCT Number: NCT00496184
Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 3
Primary location
Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital, Nahariya, Israel
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Women diagnosed with vestibulitis according to Friedrich's criteria:
- Severe pain with vestibular touch or attempted vaginal entry.
- A positive Q-tip test: pain produced by touching the vestibule with a cotton tipped applicator.
- Physical findings limited to varying degree of vestibular erythema.
- 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
- Women who have undergone vestibulectomy.
- Active vaginal or pelvic infection.
- A medical disease uch as Diabetes, immune suppression.
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Western Galilee Hospital-Nahariya
Other Gov
Registry information
Official study title
Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2008
- First posted
- Jul 4, 2007
- Registry last updated
- May 8, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Effects of Flourish HEC on Localized Provoked Vulvodynia
NCT05478746
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Virginia Beach, Virginia, United States
View Trial DetailsE7 TCR T Cells for Human Papillomavirus-Associated Cancers
NCT02858310
Carcinoma, Carcinoma in Situ
Bethesda, Maryland, United States
View Trial DetailsPhase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
NCT00004316
Cystitis, Cystitis, Interstitial
Pittsburgh, Pennsylvania, United States
View Trial DetailsArtesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
NCT03792516
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Baltimore, Maryland, United States
View Trial Details