Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast C… (NCT01370551) | Clinical Trial Compass
CompletedPhase 1
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Belgium, Germany16 participantsStarted 2011-04
Plain-language 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.
Who can participate
Age range52 Years – 75 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Patients with breast cancer on non-steroidal AI therapy (AI therapy start at least 6 months ago, and are scheduled to receive them during the study)
✓. Postmenopausal and age ≥52 with cessation of menses for at least 12 months
âś“. Age 52 - 75 years
âś“. Clinical symptoms of vaginal atrophy
âś“. Vaginal pH \> 5.0
✓. Karnofsky score ≥80%
âś“. Signed Informed Consent Form together with contractual capability
Exclusion criteria
âś•. Local or systemic use of any other sexual hormones (estrogens, progestins, androgens), 6 months before and during study
âś•. Local or systemic use of phytoestrogens or products known for or taken to improve vaginal mucosal function, risk of vaginal infections, or vulvovaginal symptoms, 4 weeks before and during study
âś•. Local or systemic use of any other anti-infectives, 2 weeks before and during study
âś•. Use of any other vaginal medication, vaginal rinses and/or moisturizers, gels containing xylocain or other analgesic products to decrease pain during intercourse, 1 week before and during study
âś•. Known or suspected hypersensitivity or intolerance to the study medications, inclusive their excipients
What they're measuring
1
Serum Concentrations of Estriol (E3)
Timeframe: -0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28
2
Calculation of Pharmacokinetic Parameters Estriol: Cmax
Timeframe: Days 0 and 28
3
Calculation of Pharmacokinetic Parameters Estriol: Tmax
Timeframe: Days 0 and 28
4
Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)