Phase 1
N=16
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Atrophic Vaginitis
Bottom Line
View on ClinicalTrials.gov: NCT01370551 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Serum Concentrations of Estriol (E3) — 0; 0.91; 3.83; 1.58 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Estriol 0.03 mg, lyophylized lactobacillus (Drug)
- Age
- Adult, Older Adult · 52+ yrs
- Sex
- Female
- Sponsor
- Medinova AG
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Concentrations of Estriol (E3) |
0; 0.91; 3.83; 1.58; 11.04; 1.55 | — |
| PRIMARY Calculation of Pharmacokinetic Parameters Estriol: Cmax |
104.5; 15.8 | — |
| PRIMARY Calculation of Pharmacokinetic Parameters Estriol: Tmax |
2.5; 7.2 | — |
| PRIMARY Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC) |
212; 130.7 | — |
| SECONDARY Baseline / Trough Serum Concentrations of Estriol |
0.00; 5.11; 0.91; 0.00; 0.00 | — |
| SECONDARY Vaginal pH |
6.0; 4.6; 4.4; 4.6; 4.5 | — |
| SECONDARY Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH) |
36.46; 34.52; 34.02; 34.2; 35.13 | — |
| SECONDARY Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG) |
73.04; 74.24; 71.29; 73.35; 72.43 | — |
| SECONDARY Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH) |
107.88; 103.71; 98.94; 103.55; 105.93 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01370551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.