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:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT03857893
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women suffering of Vulvo-Vaginal atrophy (VVA), included Breast Cancer survivors defined as having self-identified at least one mild to severe of the following symptoms:
1. Vaginal dryness (none, mild, moderate or severe),
2. Vaginal and/or vulvar irritation/itching (none, mild, moderate or severe),
3. Vaginal pain associated with sexual activity (none, mild, moderate or severe)
* Postmenopausal women with VVA confirmed by at least one of the following criteria:
1. A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
2. A vaginal pH \> 5
* Postmenopausal women between 40 and 75 years of age (non hysterectomized or hysterectomized). Menopause will be assessed either by amenorrhea of \> 1 year and / or by Follicle Stimulating Hormone (FSH) \> 30 UI/L and estradiol (E2) \< 20 pg/ml
* They must have either a contraindication to hormonal therapies, a failure of previous use of hormonal therapies (either systemic and/or local) or must have refused to take hormonal therapy.
* Willing to participate in the study and sign an informed consent.
Exclusion Criteria:
* Undiagnosed abnormal genital bleeding.
* The administration of any investigational drug within 30 days of screening visit.
* Endometrial hyperplasia at biopsy performed at screening or endometrial cancer.
* Use of estrogens/progestins products (vaginal, oral, pellet, transdermal....) in the 4 weeks to months (depending on the product used) prior study entry.
* Presence of severe medical disease or neurological disease or important co-morbidities.
* Other gynaecological malignancies.
* Recent vaginal surgery .
* A clinically relevant prolapse (Pelvic Organ Prolapse-Quantification System (POP-Q) ≤ 2)
* Current urinary tract or vaginal infection or recent sexually transmitted disease
* Anticoagulant treatment
* People with pacemakers and/or other implanted electrodes (Intra-Uterine Device (IUD) and surgical pelvic implants for sterilization are not considered as contraindication)
* Disabled people unable to communicate
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03857893
Study Brief:
Protocol Section:
NCT03857893