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Completed

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).

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Key information

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

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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

Nifedipine cream topical application

Drug

Primary outcomes

  1. 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

  1. 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.

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