Botulinum Toxin Injection for Treatment of Vaginismus
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|ClinicalTrials.gov Identifier: NCT00638066|
Recruitment Status : Unknown
Verified March 2008 by Tehran University of Medical Sciences.
Recruitment status was: Active, not recruiting
First Posted : March 18, 2008
Last Update Posted : March 18, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Vaginismus||Drug: botulinum toxin Drug: botulinum toxin A||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||April 2008|
|Estimated Study Completion Date :||April 2008|
Drug: botulinum toxin A
250 units of botulinum toxin A once
|Active Comparator: 2||
Drug: botulinum toxin
500 units of botulinum toxin for the second arm
- 50 percent of patient satisfaction [ Time Frame: first two month ]
- total patient satisfaction [ Time Frame: next four month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638066
|Iran, Islamic Republic of|
|Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Abbas noroozi, PhD||Tehran University of Medical Sciences|