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NCT05445115 Clinical Trial

The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device

Dyspareunia Clinical Trial

Official title:
DAT: Dyspareunia Alleviation Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05445115
Other study ID # CIP-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 14, 2021
Est. completion date April 30, 2023

Study information
Verified date June 2022
Source JSP Innovations
Contact Leigh Ann Grossman
Phone 217-615-1144
Email leighann176@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to evaluate the use of a medical device in relieving collision dyspareunia

Recruitment information / eligibility
Status Recruiting
Enrollment 111
Est. completion date April 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: Females 18 years of age and older with a diagnosis of collision dyspareunia - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Mollie device
medical device

Locations
Country Name City State
United States Vero Clinics Decatur Illinois

Sponsors (1)
Lead Sponsor Collaborator
JSP Innovations

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dyspareunia Alleviation The Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v.4.0, Change from Baseline in Pain Scores on the Visual Analog Scale at 13 Weeks 12 weeks
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