Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07402395
Eligibility Criteria:
Inclusion Criteria:
* Adult women (≥18 years).
* Women with mild or moderate vulvar atrophy, including deflation or vulvar ptosis, or with visible signs of genital aging, or women seeking aesthetic improvement of the vulvovaginal area, including peri-menopausal or women with genitourinary syndrome of menopause (GSM).
* Ability and willingness to comply with all study visits and procedures.
* Sufficient predisposition and capacity, in the investigator's judgment, to complete study questionnaires.
* For women of childbearing potential: negative pregnancy test and agreement to use reliable contraception during the study (hormonal contraception, IUD/IUS, condoms, diaphragm with spermicide, vasectomized partner, or true abstinence).
Exclusion Criteria:
* Allergy or hypersensitivity to any component of BtH Intimate 2.0%.
* Pregnancy or planned pregnancy, or breastfeeding.
* Active infection or pathology in the area to be treated.
* Presence of bacterial, fungal, or viral infection in or near the vulvovaginal region, or current treatment for such conditions.
* Known tendency to develop hypertrophic scars or keloids.
* Signs of inflammation in or near the treatment area, or receiving treatment for inflammation.
* History of any vulvovaginal rejuvenation procedure within the last 6 months or during the study (e.g., laser, radiofrequency, electrotherapy, dermal fillers, PRP, etc.).
* Unrealistic or disproportionate expectations regarding treatment outcomes.
* Incorrectly selected participants (those found retrospectively to fail inclusion or meet exclusion criteria) will be replaced.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07402395
Study Brief:
Protocol Section:
NCT07402395