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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Medinova AG

Current Primary Outcome:

  • Serum concentrations of estriol (E3), estradiol (E2), estrone (E1) [ Time Frame: -0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 1 and 28 ]
  • Calculation of pharmacokinetic parameters: AUC0-24, intraindividual mean, Cmax and tmax [ Time Frame: on days 1 and 28 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Baseline / trough serum concentrations of estriol, estradiol, estrone, FSH, LH and SHBG [ Time Frame: at all visits during 12 weeks ]
  • Vaginal pH [ Time Frame: at all visits during 12 weeks ]
  • Clinical symptoms and signs [ Time Frame: at all visits during 12 weeks ]
  • Vaginal maturation index [ Time Frame: at all visits during 12 weeks except screening ]
  • Lactobacillary grade [ Time Frame: at all visits during 12 weeks except screening ]
  • Bacterial vaginosis (BV) score [ Time Frame: at all visits during 12 weeks except screening ]
  • Aerobic vaginitis (AV) score [ Time Frame: at all visits during 12 weeks except screening ]
  • Presence of Candida hyphae or blastospores [ Time Frame: at all visits during 12 weeks except screening ]
  • Global assessment of efficacy [ Time Frame: visits C1 to C4 during 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Medinova AG

Dates:
Date Received: May 10, 2011
Date Started: April 2011
Date Completion:
Last Updated: August 21, 2012
Last Verified: January 2011