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

JSP Innovations

Status: Enrolling

Conditions: Dyspareunia

Treatments: Device: Mollie device

Study type: Interventional

Funder types: Other

Identifiers

NCT05445115

CIP-01

Details and patient eligibility

About

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

Enrollment: 111 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 2 patient groups

Treatment

Experimental group

Description:

Actual treatment device

Treatment:

Device: Mollie device

Sham

Sham Comparator group

Description:

Sham/placebo device

Treatment:

Device: Mollie device