At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Estriol 0.03 mg, lyophylized lactobacillusdrug
Likely dose
Estriol 0.03 mg, lyophylized lactobacillusfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Estriol 0.03 mg, lyophylized lactobacillus for Atrophic Vaginitis. Completed, enrolled 16 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophic Vaginitis
CountriesBelgium, Germany
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedJun 2011
Primary CompletionJul 2012
TodayJul 2026
First PostedJun 10, 2011
Enrollment StartApr 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.1 years ago
Interventions
Estriol 0.03 mg, lyophylized lactobacillusdrug
Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;