Spots Global Cancer Trial Database for Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
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Trial Identification
Brief Title: Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Official Title: A Clinical Study of Pharmacokinetics, Efficacy and Safety of Vaginal Application of Lyophilised Lactobacilli and 0.03 mg Estriol (Gynoflor®) on Atrophic Vaginitis in Postmenopausal Breast Cancer Patients Treated With Aromatase Inhibitors
Study ID: NCT01370551
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to assess the longterm safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer patients who have been treated with aromatase inhibitors.
Detailed Description:
Keywords
Eligibility
Minimum Age: 52 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University Hospital Leuven, Leuven, , Belgium
Department of Obstetrics and Gynaecology, University of Regensburg, Regensburg, , Germany
Contact Details
Name: Patrick Neven, Prof. Dr.
Affiliation: University Hospital Leuven, Belgium
Role: PRINCIPAL_INVESTIGATOR
Name: Stefan Buchholz, PD Dr.
Affiliation: Department of Obstetrics and Gynaecology, University of Regensburg, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Gilbert Donders, Prof. Dr.
Affiliation: Femicare, University Hospital, Leuven, Belgium
Role: PRINCIPAL_INVESTIGATOR
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