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

DAT: Dyspareunia Alleviation Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05445115
Enrollment
111
Registered
2022-07-06
Start date
2021-09-14
Completion date
2023-04-30
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspareunia

Brief summary

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

Interventions

DEVICEMollie device

medical device

Sponsors

JSP Innovations
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Subjects are blinded as to which arm they are participating in

Intervention model description

Treatment arm and sham arm

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Females 18 years of age and older with a diagnosis of collision dyspareunia -

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Dyspareunia Alleviation12 weeksThe 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

Countries

United States

Contacts

Primary ContactLeigh Ann Grossman
leighann176@yahoo.com217-615-1144

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026