NCT05445115UnknownNot Applicable
DAT: Dyspareunia Alleviation Trial
JSP Innovations1 site in 1 country111 target enrollmentStarted: September 14, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Dyspareunia Alleviation
Study Overview
Brief Summary
Study to evaluate the use of a medical device in relieving collision dyspareunia
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Subjects are blinded as to which arm they are participating in
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Females 18 years of age and older with a diagnosis of collision dyspareunia -
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment
Experimental
Actual treatment device
Intervention: Mollie device (Device)
Sham
Sham Comparator
Sham/placebo device
Intervention: Mollie device (Device)
Outcomes
Primary Outcomes
Dyspareunia Alleviation
Time Frame: 12 weeks
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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