Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western Galilee Hospital-Nahariya
• Treatments: Nifedipine

Criteria

Inclusion Criteria:

1. 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.

2. Non-pregnant women aged 18-45.

3. Women use effective contraception and are not interested in becoming pregnant during the study period.

4. No known Nifedipine allergy.

5. No medical diseases.

Exclusion Criteria:

1. Women who have undergone vestibulectomy.

2. Active vaginal or pelvic infection.

3. A medical disease uch as Diabetes, immune suppression.