Vaginismus Clinical Trial
Official title:
Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus
Verified date | March 2008 |
Source | Tehran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
According to high rate of vaginismus (about 10 percent) which leads to unconsummated
marriage (about 1 percent) and low efficacy for conventional treatments such as biofeedback
therapy, analgesic drugs and pain killers and surgical treatment, there`s necessity to find
more effective method.
In our previous study, injecting botulinum toxin in 23 patients cured 75% of them.Now we are
to make comparison between different doses of toxin injection and record the patient sexual
satisfaction.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Unconsummated marriage - Difficult mating - No response to biofeedback Exclusion Criteria: - Patient unlikely to have toxin injection - Not having mutual life with partner - Non treated pelvic and vaginal infection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center | Tehran |
Lead Sponsor | Collaborator |
---|---|
Tehran University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 50 percent of patient satisfaction | first two month | Yes | |
Secondary | total patient satisfaction | next four month | Yes |
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