VaginismusPhase 3NCT00638066
Botulinum Toxin Injection for Treatment of Vaginismus
A Phase 3 study testing botulinum toxin and botulinum toxin A in people with Vaginismus, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginismus
- What is being tested?
- botulinum toxin and botulinum toxin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Oct 2007to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unconsummated marriage
- Difficult mating
- No response to biofeedback
Who cannot join
- Patient unlikely to have toxin injection
- Not having mutual life with partner
- Non treated pelvic and vaginal infection
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center
Tehran, Tehran Province
About this study
Official title: Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus
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.
Read the detailed 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.
- Conditions
- Vaginismus
- Being tested
- botulinum toxin, botulinum toxin A
- Keywords
- vaginismus, botulinum toxin A, dyspareunia, unconsummated marriage
- Medical subject headings
- Vaginismus, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxinDrug
500 units of botulinum toxin for the second arm
botulinum toxin ADrug
250 units of botulinum toxin A once
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: botulinum toxin A |
| 2 | Active comparator | Not described Receives: Drug: botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
50 percent of patient satisfaction
Measured: first two month
Secondary outcomes (1)
total patient satisfaction
Measured: next four month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2008 (estimated)
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Abbas noroozi, PhD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638066
- Sponsor's protocol ID
- 130/6/6081
- Other IDs
- 130/6/6081
- Status last verified
- Mar 2008
- First submitted
- 10 Jan 2008
- Last updated
- 18 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus
- ClinicalTrials.gov ID
- NCT00638066
- Acronym / sponsor ID
- 130/6/6081
- Conditions
- Vaginismus
- Keywords
- vaginismus, botulinum toxin A, dyspareunia, unconsummated marriage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Apr 2008 (estimated)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: botulinum toxin A |
| 2 | Active comparator | Drug: botulinum toxin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unconsummated marriage
- Difficult mating
- No response to biofeedback
Key exclusion criteria (3 listed)
- Patient unlikely to have toxin injection
- Not having mutual life with partner
- Non treated pelvic and vaginal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin500 units of botulinum toxin for the second arm | Drug | 2 |
| botulinum toxin A250 units of botulinum toxin A once | Drug | 1 |
Primary outcome
50 percent of patient satisfaction
Time frame: first two month
1 secondary outcome
total patient satisfaction
Time frame: next four month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2008.
Related trials for Vaginismus
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Implementing Virtual Reality Exposure Therapy for Vaginismus: From Efficacy to Clinical Integration (VIVID 3)
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Virtual Reality Exposure for Vaginismus: A Replicated Single-Case Design
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Measuring Pelvic Floor Muscle Fitness Before and After Treatment
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Early Psychological Intervention After Rape
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbas noroozi, PhD principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing botulinum toxin and botulinum toxin A in people with Vaginismus, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50 percent of patient satisfaction (time frame: first two month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2008.