EUCTR2021-001801-56-ATActive, not recruitingPhase 1
Efficacy and Safety of a hyaluronic and lactic acid containing vaginal gel HydroSanta® Vaginalgel” for the treatment of vaginal dryness symptoms – a multicenter randomized two-arm study
Gynial GmbH0 sites90 target enrollmentStarted: August 30, 2021Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Informed consent
- •Biological sex: female (women only)
- •Women with moderate or severe vaginal dryness
- •Age > 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Currently under vaginal atrophy treatment
- •Vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV)
- •Patients with breast cancer, uterine cancer or estrogen hormone-dependent tumors, and genital bleeding of unknown origin
- •Known allergy against ingredients of the study intervention (e.g. estriol)
Investigators
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