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

Two center phase I pharmacokinetic study assessed circulating estrogens in breast cancer patients on a non-steroidal aromatase inhibitor (NSAI) with vaginal atrophy using vaginal ultra-low-dose 0.03 mg estriol (E3) and Lactobacillus combination vaginal tablets (Gynoflor). 16 women on nonsteroidal aromatase inhibitor with severe vaginal atrophy applied a daily vaginal tablet of Gynoflor for 28 days followed by a maintenance therapy of 3 tablets weekly for 8 weeks.

Inclusion criteria

• 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
• Age 52 - 75 years
• Clinical symptoms of vaginal atrophy
• Vaginal pH > 5.0
• Karnofsky score ≥80%
• Signed Informed Consent Form together with contractual capability

Exclusion criteria

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