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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT05211505
Eligibility Criteria:
Inclusion Criteria:
1. Post-menopausal women with the subjective symptomatology of vulvovaginal atrophy with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a score of at least "2" (moderate) for the parameter dryness at screening and visit 1 (day 1)
* Thereof at least for 48 included patients: sexual activity with dyspareunia
* Thereof at least 32 included sexually active patients with at least moderate (score of "2") dyspareunia
2. Natural cessation of last menstruation more than 12 months before screening OR bilateral oophorectomy with or without hysterectomy more than 3 months before screening
3. Signed written informed consent before participation in the clinical investigation
Exclusion Criteria:
1. Vaginal inflammation which is not caused by vulvovaginal atrophy
2. Non-healed vaginal surgery
3. Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (selective estrogen receptor modulators) within 3 months before visit 1 (day 1) and / or during the conduct of this clinical investigation
4. Local hormonal therapy (vagina/vulva) within 3 months before Screening (also when used for the brightening/pretreatment of cytological smears)
5. Any use of products (including lubricants), other than the investigational medicinal device, applied intravaginally or on the vulva during the clinical investigation (except usual cleansing products)
6. Systemic corticosteroids within 21 days before visit 1 (day 1) and during the conduct of this clinical investigation (corticoid asthma sprays are allowed)
7. Use of antibiotics, antiseptics or antimycotics with expected or suspected systemic or vaginal/vulvar bioavailability within 21 days before visit 1 (day 1) and / or during this clinical investigation
8. Known hypersensitivity against any of the ingredients of the investigational medical device
9. Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05211505
Study Brief:
Protocol Section:
NCT05211505