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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05263102
Eligibility Criteria:
1. Subjects who have the relevant syndromes of vulvovaginal atrophy, and who are
1. In the status of menopause (≥12 months after the last menstrual cycle); or
2. FSH \> 40 mIU/ml and estradiol level \< 20 pg/ml; or
3. bilateral ovary resection; or
4. the patients, i.e. breast cancer patients, who completed cancer therapy
2. Subjects have self-identified at least one of mild to moderate or severe symptoms listed below that are the most bothersome to her.
1. Vaginal dryness
2. Vaginal and/or vulvar irritation/itching
3. Dysuria
4. Vaginal pain associated with sexual activity
5. Vaginal bleeding associated with sexual activity
3. Subjects are willing to comply with all aspects of the study and have signed informed consent form.
Exclusion Criteria:
1. Subjects have been diagnosed with cervical or vaginal malignant neoplasms
2. Subjects with abnormal undiagnostic genital bleeding
3. Subject with active vaginal infection
4. Subjects with vaginal pH value \< 4.5
5. Subjects are under hormone replacement therapy within three months
6. Subjects are under phytoestrogen treatment within two month
7. Subjects use of vaginal douche, lubricant or moisturizer in one week
8. Subjects are hypersensitive to sodium hyaluronate, carrageenan
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT05263102
Study Brief:
Protocol Section:
NCT05263102