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Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients

NCT01370551 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-10-15

Study results available
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Summary

The purpose of this study is to assess the long term 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.

Conditions

  • Atrophic Vaginitis

Interventions

DRUG

Estriol 0.03 mg, lyophylized lactobacillus

Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;

Sponsors & Collaborators

  • Medinova AG

    lead INDUSTRY

Principal Investigators

  • Patrick Neven, Prof. Dr. · University Hospital Leuven, Belgium

  • Stefan Buchholz, PD Dr. · Department of Obstetrics and Gynaecology, University of Regensburg, Germany

  • Gilbert Donders, Prof. Dr. · Femicare, University Hospital, Leuven, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
52 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Belgium
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01370551 on ClinicalTrials.gov