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:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT03568604
Eligibility Criteria:
Inclusion Criteria:
* provides written informed consent and HIPAA authorization before any study procedures are conducted;
* has a body mass index (BMI) \< 37 kg/m2
* is menopausal either naturally (at least 12 months amenorrheic) or 6 weeks after a bilateral salpingo-oophorectomy prior to natural menopause; subjects with hysterectomy only must have a serum FSH \> 40 mIU/mL;
* has vulvovaginal atrophy with moderate to severe dyspareunia;
* has at least one score ≥ 2 on cotton-tipped swab test
* agrees to comply with the study procedures and visits.
Exclusion Criteria:
* has a hypersensitivity to DHEA;
* has used prasterone in the past 6 months;
* has documented or suspected breast cancer;
* has undiagnosed genital bleeding:
* has clinically significant findings on physical examination;
* has uncontrolled hypertension;
* has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
* is currently on local or systemic androgen therapy including local or systemic testosterone (washout 14 days for local or topical androgen or non-depot injection, 1 month for depot, 6 months for pellet;
* is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy);
* is currently using a selective estrogen receptor modulator (SERM) or products that have estrogenic or anti-estrogenic effects within last month;
* has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
* has received an investigational drug within 30 days prior to signing consent;
* has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT03568604
Study Brief:
Protocol Section:
NCT03568604