This trial is active, not recruiting.

Condition vaginismus
Treatments botulinum toxin, botulinum toxin a
Phase phase 3
Sponsor Tehran University of Medical Sciences
Start date October 2007
End date April 2008
Trial size 40 participants
Trial identifier NCT00638066, 130/6/6081


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
botulinum toxin a
250 units of botulinum toxin A once
(Active Comparator)
botulinum toxin
500 units of botulinum toxin for the second arm

Primary Outcomes

50 percent of patient satisfaction
time frame: first two month

Secondary Outcomes

total patient satisfaction
time frame: next four month

Eligibility Criteria

Female participants from 20 years up to 45 years old.

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

Additional Information

Official title Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus
Principal investigator Abbas noroozi, PhD
Description Vaginismus is the recurrent or persistent involuntary contraction of the perineal muscles surrounding the outer third of the vagina when penile, finger, tampon, or speculum penetration is attempted . Vaginismus can be primary, in which the women has never been able to have intercourse, or secondary, which is often due to acquired dyspareunia. It is relatively rare, affecting about 1% of women . Treatment of vaginismus is directed toward extinguishing the conditioned involuntary vaginal spasm. This can be accomplished by teaching Kegel exercises to acquaint the patient with voluntary control of her levator muscles. Medications such as lubricants, anesthetic creams, propranolol, or alprazolam to reduce anxiety have been used effectively, but approximately 10% of patients do not respond. Botulinum toxin type A has been successfully used to treat a wide range of muscular disorders such as strabismus, blepharospasm, and cervical dystonia. It is also been used to reduce facial lines and wrinkles.The extent of paralysis depends on the amount of toxin to which there is exposure relative to muscle bulk.In our previous study, one week after injecting botulinum toxin in 23 patients (95.8%) had a vaginal exam, which showed no or little resistance; 18 (75%) achieved satisfactory intercourse after the first injection. Now we are to make comparison between different doses of toxin injection and record the patient sexual satisfaction.
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Tehran University of Medical Sciences.