The trial assesses the efficacy and safety of a vaginalgel for dryness

Phase 1

• Conditions: MedDRA version: 21.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophySystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-001801-56-AT
• Lead Sponsor: Gynial GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-30
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 90

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

•Pregnancy
•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified