Treatment of vulvar vestibulitis by an antioxidant cream: a double-blind, placebo-controlled, parallel group multi-center study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004220-13-SE

Enrollment

Registered

2005-05-23

Start date

2005-06-08

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar vestibulitis, a recently discovered disease, which mainly affects young women. The symptoms are severe vaginal pain. Level: PT Classification code 10047780

Interventions

Product Name: Antioxidant cream Pharmaceutical Form: Cream Other descriptive name: Vitamin A (Retinol palmitate), 100 g cream Concentration unit: IU international unit(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy women as determined by medical history and actual health status. 2. Between the ages of 18 and 30 years, inclusive. 3. Fulfills Friedrich criteria for vestibulitis: -Symptoms of vestibulitis for at least 6 months. -Vestibular erythema -Tenderness to pressure with cotton tips -Penetration pain 4. Use of contraception. 5. Have been informed about the study and given written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Concomitant medication containing vitamin A. 2. Concomitant medication in vulva. 3. Other concomitant treatment specific for vestibulitis, except counselling 4. Fungal infection confirmed by a “wet smear test”. 5. Chlamydia infection confirmed by a urine test. 6. Never experienced penetrating intercourse. 7. Vulvar condyloma accuminatum. 8. Pregnancy confirmed by a urine pregnancy test. 9. Breast-feeding. 10. Participation in another clinical study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether the antioxidant cream has a significantly better effect than placebo in women suffering from vulvar vestibulitis based on the patient´s opinion.;Secondary Objective: To evaluate changes in the patient´s sense of pain by a scale graded 1-10. To evaluate changes in the patient´s opinion about sexual life by a questionnaire. To investigate the tolerance of an antioxidant cream.;Primary end point(s): Changes of the condition after 3 months of treatment, based on the patient´s personal opinion. The question "Have your symptoms decreased by using the cream?" will be answered by "Yes" or "No".	—

Measure

Time frame

Main Objective: To investigate whether the antioxidant cream has a significantly better effect than placebo in women suffering from vulvar vestibulitis based on the patient´s opinion.;Secondary Objective: To evaluate changes in the patient´s sense of pain by a scale graded 1-10. To evaluate changes in the patient´s opinion about sexual life by a questionnaire. To investigate the tolerance of an antioxidant cream.;Primary end point(s): Changes of the condition after 3 months of treatment, based on the patient´s personal opinion. The question "Have your symptoms decreased by using the cream?" will be answered by "Yes" or "No".

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026