Prospective on Market Patient-reported Outcomes for Milli

Running, not enrolling

Conditions studied: Vaginismus, Dyspareunia

In brief

To assess the effectiveness of the Milli device in achieving vaginal intercourse

Key facts

Study ID

NCT06397885

Run by

Materna Medical

People needed

200

Starts

2024-05-12

Expected to finish

2025-12-30

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 vaginal procedures that result in extensive scarring (with the exception of hysterectomy procedures)
• Subject or subject's partner experiences other conditions preventing intercourse (e.g., erectile dysfunction, lack of libido)

Where it is running

• Materna Clinic — Mountain View, California, United States

Full record on ClinicalTrials.gov

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