NCT01370551 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2024-10-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Serum Concentrations of Estriol (E3)

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outcome · POSTED

Calculation of Pharmacokinetic Parameters Estriol: Cmax

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outcome · POSTED

Baseline / Trough Serum Concentrations of Estriol

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outcome · POSTED

Vaginal pH

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outcome · POSTED

Calculation of Pharmacokinetic Parameters Estriol: Tmax

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outcome · POSTED

Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)

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outcome · POSTED

Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)

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outcome · POSTED

Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)

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outcome · POSTED

Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. 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) 2. Postmenopausal and age ≥52 with cessation of menses for at least 12 months 3. Age 52 - 75 years 4. Clinical symptoms of vaginal atrophy 5. Vaginal pH \> 5.0 6. Karnofsky score ≥80% 7. Signed Informed Consent Form together with contractual capability 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
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 52 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Gynoflor vaginal tablets 1/day x 4 weeks, then 3/week for 8 weeks
intervention Names
Drug: Estriol 0.03 mg, lyophylized lactobacillus
label
Gynoflor
type
EXPERIMENTAL

interventions

arm Group Labels
Gynoflor
description
Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;
name
Estriol 0.03 mg, lyophylized lactobacillus
other Names
Gynoflor
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 16
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/). The lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).
measure
Serum Concentrations of Estriol (E3)
time Frame
-0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28
description
Cmax is the highest measured concentration
measure
Calculation of Pharmacokinetic Parameters Estriol: Cmax
time Frame
Days 0 and 28
description
Tmax is the peak time at which the Cmax (maximum concentration) was measured
measure
Calculation of Pharmacokinetic Parameters Estriol: Tmax
time Frame
Days 0 and 28
description
Area under the curve from administration to the last measured concentration (AUC0-24)
measure
Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)
time Frame
Days 0 and 28

secondary Outcomes

measure
Baseline / Trough Serum Concentrations of Estriol
time Frame
Days 0, 14, 28, 56 and 84
description
The normal vaginal pH is 3.8-5.0 pH is a logarithmic scale used to specify the acidity or basicity of aqueous solutions. The scale has values ranging from zero (the most acidic) to 14 (the most basic). Pure water has a pH value of 7. This value is considered neutral-neither acidic or basic.
measure
Vaginal pH
time Frame
at all visits during 12 weeks
measure
Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)
time Frame
Days 0, 14, 28, 56 and 84
measure
Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)
time Frame
Days 0, 14, 28, 56 and 84
measure
Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)
time Frame
Days 0, 14, 28, 56 and 84

Full study description

brief 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.
detailed Description: 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.

Source references

references

citation
Donders G, Neven P, Moegele M, Lintermans A, Bellen G, Prasauskas V, Grob P, Ortmann O, Buchholz S. Ultra-low-dose estriol and Lactobacillus acidophilus vaginal tablets (Gynoflor((R))) for vaginal atrophy in postmenopausal breast cancer patients on aromatase inhibitors: pharmacokinetic, safety, and efficacy phase I clinical study. Breast Cancer Res Treat. 2014 Jun;145(2):371-9. doi: 10.1007/s10549-014-2930-x. Epub 2014 Apr 10.
pmid
24718774
type
RESULT
citation
Buchholz S, Mogele M, Lintermans A, Bellen G, Prasauskas V, Ortmann O, Grob P, Neven P, Donders G. Vaginal estriol-lactobacilli combination and quality of life in endocrine-treated breast cancer. Climacteric. 2015 Apr;18(2):252-9. doi: 10.3109/13697137.2014.991301. Epub 2015 Jan 20.
pmid
25427450
type
RESULT
citation
Donders G, Bellen G, Neven P, Grob P, Prasauskas V, Buchholz S, Ortmann O. Effect of ultra-low-dose estriol and lactobacilli vaginal tablets (Gynoflor(R)) on inflammatory and infectious markers of the vaginal ecosystem in postmenopausal women with breast cancer on aromatase inhibitors. Eur J Clin Microbiol Infect Dis. 2015 Oct;34(10):2023-8. doi: 10.1007/s10096-015-2447-1. Epub 2015 Jul 30.
pmid
26223323
type
RESULT