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 range
18 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.