Investigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA

• Status: Completed
• Trial end date: 2020-08-11
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: Bremer Pharmacovigilance Service GmbH; proDERM Institut für Angewandte Dermatologische Forschung GmbH

Criteria

Inclusion Criteria:

• Post-menopausal women with subjective symptomatology of vulvovaginal atrophy

• Signed written informed consent before participation in the trial

Exclusion Criteria:

• Known hypersensitivity against any of the ingredients of the investigational product

• Systemic hormonal replacement therapy, or phytohormonal therapy or use of SERMs within 3 months before and / or during the conduct of the trial

• Local hormonal therapy (vagina/vulva) within 3 months before the trial

• If in the opinion of the investigator the patient should not participate in the study for any reason