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

Exclusion Criteria

• •1. Local or systemic use of any other sexual hormones (estrogens, progestins, androgens), 6 months before and during study
• •2. 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
• •3. Local or systemic use of any other anti-infectives, 2 weeks before and during study
• •4. 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
• •5. Known or suspected hypersensitivity or intolerance to the study medications, inclusive their excipients
• •6. Suspicion of or clinically manifest sexually transmitted infections (infections with Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, genital herpes, Trichomonas vaginalis, genital condylomata, HIV)
• •7. Clinical evidence of vaginal infections requiring extra treatment
• •8. Any infections of the upper genital tract
• •9. Hysterectomy
• •10. Genital haemorrhage of unknown origin
• •11. Malignant or pre-cancerous conditions of the uterus, vulva and/or vagina (PAP smear less than 3 years ago)
• •12. Acute thrombophlebitis, thromboembolic disorders or a history of these disorders in association with previous use of oestrogen preparations
• •13. Abuse of alcohol or drugs
• •14. All chronic illnesses which could influence the absorption, distribution, biotransformation or elimination of the test preparation
• •15. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient in significant risk, may confound the study result, or may interfere significantly with the patient's participation in the study
• •16. BMI lower than 18.5 or higher than 30
• •17. Patient on steroidal AIs (aromasin)
• •18. Vulvo-dermatological conditions (like Lichen sclerosus, Lichen rubrus, Psoriasis)
• •19. Genital prolapses
• •20. Endometriosis
• •21. Use of antibiotics or chemotherapeuticals which are harmful to lactobacilli
• •22. Participation of patient in another investigational drug study, with the exception of treatment optimisation studies with non-steroidal aromatase inhibitors (AI)s
• •23. Previous participation in this study
• •24. Patient is a relative of, or staff directly reporting to the investigator
• •25. Patient is an employee of the sponsor