local botox administration on patients with vulvar vestbulitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004633-33-DK

Enrollment

Registered

2005-01-18

Start date

2005-02-15

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 vestibulits

Interventions

Trade Name: Botox Pharmaceutical Form: Powder for solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosed with vulvar vestibulitis - No use of local analgetics ex. Lidocaine - Safe birth control 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - treated with Botox before - infection in the vula g vagina - age < 18 - skindisease - pregnancy - neurological disease: Myasthenia gravis, ALS, Lambert-Eaton - diabetes - using following medicine: Calcium-antagonist, Aminoglycoside, Magnesium-sulfate, Steroid

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate the effect of Botox on vulvar vestibulitis by measuring the level of pain by VAS( Visual Analag Score);Secondary Objective: Investigate the effect of Botox on the patients suffering from vulvar vestibulitis by ivestigating sexual function, life-quality, spouse-relationship and depression. ;Primary end point(s): Botox relieves the women of pain	—

Countries

Denmark

Outcome results

None listed

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