Phase 1CompletedAge-related condition
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
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
- Sponsor
- Medinova AG (Industry)
- Enrollment
- 16 enrolled
- Conditions
- Atrophic Vaginitis
- Interventions
- Estriol 0.03 mg, lyophylized lactobacillus
- Ages
- adults, older adults
- Registry
- NCT01370551
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Serum Concentrations of Estriol (E3)
- Calculation of Pharmacokinetic Parameters Estriol: Cmax
- Calculation of Pharmacokinetic Parameters Estriol: Tmax
- Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)
History
Results first posted
Last registry update
Primary completion
Registered
Started