NCT05445115

Brief Summary

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

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
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

June 24, 2022

Last Update Submit

June 30, 2022

Conditions

Dyspareunia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Treatment

EXPERIMENTAL

Actual treatment device

Device: Mollie device

Sham

SHAM COMPARATOR

Sham/placebo device

Device: Mollie device

Interventions

Mollie deviceDEVICE

medical device

Also known as: Sham
ShamTreatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vero Clinics

Decatur, Illinois, 62526, United States

RECRUITING

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Central Study Contacts

Leigh Ann Grossman

CONTACT

217-615-1144leighann176@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subjects are blinded as to which arm they are participating in
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treatment arm and sham arm
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2022

First Posted

July 6, 2022

Study Start

September 14, 2021

Primary Completion

December 31, 2022

Study Completion

April 30, 2023

Last Updated

July 6, 2022

Record last verified: 2022-06

Locations

US(1)