Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women

• Status: Recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Medinova AG
• Treatments: Estrogens

Criteria

Inclusion Criteria:

• Postmenopausal women (last menstrual period more than 12 months ago or having undergone bilateral ovariectomy)

• Age ≥ 18 years

• Diagnosis of moderate to severe vaginal atrophy at screening visit with VMI < 50% and vaginal pH > 4.5

• At least one subjective symptom of vaginal atrophy (dryness, pain/burning sensation, pruritus, discharge, dyspareunia) related to a score of ≥ 65 on the visual analogue scale (VAS)

• Indication for vaginal treatment with Gynoflor® (100 million viable L. acidophilus KS 400 and estriol 30 mcg per application) for 6 weeks because of symptomatic vaginal atrophy after menopause: 1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday).

• Informed consent as documented by signature

Exclusion Criteria:

• Administration of any form of oral/transdermal hormone therapy (HT) or selective estrogen receptor modulators (SERM) or phytoestrogens within 2 months prior to entry into or during the study.

• Any use of over-the-counter vaginal products within 1 week prior to and during entry the study.

• Known hypersensitivity or allergy to the investigational product

• Estrogen dependent malignancy

• Undiagnosed genital bleeding

• Active thromboembolism

• Active vulvovaginal Candidiasis, Trichomonas vaginitis or bacterial vaginitis based on light microscopy of vaginal secretions, vaginal pH, whiff test and KOH preparation

• Active sexually transmitted infections (STI) including herpes simplex viral infection, gonorrhoea and Chlamydia.

• Active urinary tract infection.

• Pessary-users

• Immunocompromised patients including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents

• Severe liver and/or kidney disease

• Diabetes mellitus

• Polyneuropathy

• Skin disease affecting vulva or vagina, e.g. lichen sclerosus

• Known or suspected non-compliance, drug or alcohol abuse

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

• Participation in another study with investigational drug within the 30 days preceding and during the present study.