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Completed Phase 1 Interventional Accepts healthy volunteers Results available

Botox Injection for Treatment of Vaginismus

ClinicalTrials.gov ID: NCT01352546

Public ClinicalTrials.gov record NCT01352546. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 1:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open Label, Single Center, Pilot Study of the Use of BOTOX Injections, Sensorcaine Injections and Progressive Dilation Under Anesthesia for the Treatment of Primary Vaginismus

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The use of Botox injections intravaginally and progressive dilation under anesthesia has been shown to cure vaginismus. This study expands the use of Botox injections to include progressive dilation, post procedure supervised dilation and sex counseling to help women transition from dilators to intercourse. Since 2005 patients continue to experience a cure rate in excess of 90%. As of December 2012 more than 200 vaginismus patients have been treated this way. In this completed study of 30 patients with a minimum of one year follow-up 29 vaginismus patients were able to advance to pain free intercourse (97%) and one patient failed to achieve her goals presumably due to uncontrolled anxiety relating to vaginal penetration.

Study identification

NCT ID
NCT01352546
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
31 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
20 Years to 40 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2010
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012
Last update posted
Aug 6, 2017

2010 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Plastic Surgery Professional Association Manchester New Hampshire 03104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01352546, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 6, 2017 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01352546 live on ClinicalTrials.gov.

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