Clinical Research Directory

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 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)