NCT00638066

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 18, 2008

Status Verified

March 1, 2008

Enrollment Period

6 months

First QC Date

January 10, 2008

Last Update Submit

March 17, 2008

Conditions

Vaginismus

Keywords

vaginismusbotulinum toxin Adyspareuniaunconsummated marriage

Outcome Measures

Primary Outcomes (1)

  • 50 percent of patient satisfaction

    first two month

Secondary Outcomes (1)

  • total patient satisfaction

    next four month

Study Arms (2)

1

EXPERIMENTAL
Drug: botulinum toxin A

2

ACTIVE COMPARATOR
Drug: botulinum toxin

Interventions

botulinum toxinDRUG

500 units of botulinum toxin for the second arm

2
botulinum toxin ADRUG

250 units of botulinum toxin A once

1

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Unconsummated marriage
  • Difficult mating
  • No response to biofeedback

You may not qualify if:

  • Patient unlikely to have toxin injection
  • Not having mutual life with partner
  • Non treated pelvic and vaginal infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

VaginismusDyspareunia

Interventions

Botulinum ToxinsBotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental DisordersGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Abbas noroozi, PhD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

March 18, 2008

Study Start

October 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

March 18, 2008

Record last verified: 2008-03

Locations

IR(1)