Prospective on Market Patient-reported Outcomes for Milli (NCT06397885) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective on Market Patient-reported Outcomes for Milli
United States200 participantsStarted 2024-05-12
Plain-language summary
To assess the effectiveness of the Milli device in achieving vaginal intercourse
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is a female at birth aged ≥18 years of age
* Subject is able to read and understand the approved, informed consent form (ICF)
* Subject meets vaginismus and related painful sex/GPPPD criteria as defined in the DSM-5, as confirmed by having one or more of the following for greater than 6 months:
* Pelvic pain
* Vaginal pain
* Pain with vaginal intercourse
* Pain with vaginal penetration
* Fear or anxiety about vaginal or pelvic pain with vaginal penetration
* The inability to achieve vaginal penetration
* Subject currently has a sexual partner with a functional penis
* Subject is currently seeking vaginal penetration to achieve sexual intercourse
* Subject is currently unable to tolerate vaginal penetration to achieve sexual intercourse (Score of ≤1 on PEQ Question #1)
* Subject purchased Milli vaginal dilator
* Subject is not contraindicated for Milli vaginal dilator use
* Subject is able and willing to comply with study protocol
Exclusion Criteria:
* Subject has previously participated in any studies by the company in the past 12 months or has used Milli prior to enrollment
* Subject is pregnant
* Subject has an active pelvic infection (vagina or vulva)
* Subject has open wounds in the tissue inside or surrounding the vagina
* Subject has an untreated major mental health disorder (e.g., affective disorder, psychosis, PTSD)
* Subject has prior history of gender-confirming surgery, vaginal reconstruction surgery, pelvic radiation, and/or vagina…