Back to resultsThe Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device
Primary Purpose
Dyspareunia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mollie device
Sponsored by
About this trial
This is an interventional treatment trial for Dyspareunia
Eligibility Criteria
Inclusion Criteria: Females 18 years of age and older with a diagnosis of collision dyspareunia -
Exclusion Criteria:
-
Sites / Locations
- Vero ClinicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Sham
Arm Description
Actual treatment device
Sham/placebo device
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05445115
Brief Title
The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device
Official Title
DAT: Dyspareunia Alleviation Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JSP Innovations
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to evaluate the use of a medical device in relieving collision dyspareunia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment arm and sham arm
Masking
Participant
Masking Description
Subjects are blinded as to which arm they are participating in
Allocation
Randomized
Enrollment
111 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Actual treatment device
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham/placebo device
Intervention Type
Device
Intervention Name(s)
Mollie device
Other Intervention Name(s)
Sham
Intervention Description
medical device
Primary Outcome Measure Information:
Title
Dyspareunia Alleviation
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females 18 years of age and older with a diagnosis of collision dyspareunia -
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leigh Ann Grossman
Phone
217-615-1144
Email
leighann176@yahoo.com
Facility Information:
Facility Name
Vero Clinics
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh Ann Grossman
Phone
217-615-1144
Email
leighann176@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device
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