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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01370551
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : August 22, 2012
Information provided by (Responsible Party):
Medinova AG

Brief Summary:
The purpose of this study is to assess the longterm 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.

Condition or disease Intervention/treatment Phase
Atrophic Vaginitis Drug: Gynoflor Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Pharmacokinetics, Efficacy and Safety of Vaginal Application of Lyophilised Lactobacilli and 0.03 mg Estriol (Gynoflor®) on Atrophic Vaginitis in Postmenopausal Breast Cancer Patients Treated With Aromatase Inhibitors
Study Start Date : April 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arm Intervention/treatment
Experimental: Gynoflor
This study consists only of this arm.
Drug: Gynoflor
Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;

Primary Outcome Measures :
  1. Serum concentrations of estriol (E3), estradiol (E2), estrone (E1) [ Time Frame: -0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 1 and 28 ]
  2. Calculation of pharmacokinetic parameters: AUC0-24, intraindividual mean, Cmax and tmax [ Time Frame: on days 1 and 28 ]

Secondary Outcome Measures :
  1. Baseline / trough serum concentrations of estriol, estradiol, estrone, FSH, LH and SHBG [ Time Frame: at all visits during 12 weeks ]
  2. Vaginal pH [ Time Frame: at all visits during 12 weeks ]
  3. Clinical symptoms and signs [ Time Frame: at all visits during 12 weeks ]
  4. Vaginal maturation index [ Time Frame: at all visits during 12 weeks except screening ]
  5. Lactobacillary grade [ Time Frame: at all visits during 12 weeks except screening ]
  6. Bacterial vaginosis (BV) score [ Time Frame: at all visits during 12 weeks except screening ]
  7. Aerobic vaginitis (AV) score [ Time Frame: at all visits during 12 weeks except screening ]
  8. Presence of Candida hyphae or blastospores [ Time Frame: at all visits during 12 weeks except screening ]
  9. Global assessment of efficacy [ Time Frame: visits C1 to C4 during 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   52 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 STDs (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 AIs
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01370551

University Hospital Leuven
Leuven, Belgium
Department of Obstetrics and Gynaecology, University of Regensburg
Regensburg, Germany
Sponsors and Collaborators
Medinova AG
Principal Investigator: Patrick Neven, Prof. Dr. University Hospital Leuven, Belgium
Principal Investigator: Stefan Buchholz, PD Dr. Department of Obstetrics and Gynaecology, University of Regensburg, Germany
Principal Investigator: Gilbert Donders, Prof. Dr. Femicare, University Hospital, Leuven, Belgium

Responsible Party: Medinova AG Identifier: NCT01370551     History of Changes
Other Study ID Numbers: 806109
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: January 2011

Additional relevant MeSH terms:
Atrophic Vaginitis
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female