Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medinova AG
ClinicalTrials.gov Identifier:
NCT01370551
First received: May 10, 2011
Last updated: August 21, 2012
Last verified: January 2011
  Purpose

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 Intervention Phase
Atrophic Vaginitis
Drug: Gynoflor
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medinova AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Calculation of pharmacokinetic parameters: AUC0-24, intraindividual mean, Cmax and tmax [ Time Frame: on days 1 and 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Baseline / trough serum concentrations of estriol, estradiol, estrone, FSH, LH and SHBG [ Time Frame: at all visits during 12 weeks ] [ Designated as safety issue: No ]
  • Vaginal pH [ Time Frame: at all visits during 12 weeks ] [ Designated as safety issue: No ]
  • Clinical symptoms and signs [ Time Frame: at all visits during 12 weeks ] [ Designated as safety issue: No ]
  • Vaginal maturation index [ Time Frame: at all visits during 12 weeks except screening ] [ Designated as safety issue: No ]
  • Lactobacillary grade [ Time Frame: at all visits during 12 weeks except screening ] [ Designated as safety issue: No ]
  • Bacterial vaginosis (BV) score [ Time Frame: at all visits during 12 weeks except screening ] [ Designated as safety issue: No ]
  • Aerobic vaginitis (AV) score [ Time Frame: at all visits during 12 weeks except screening ] [ Designated as safety issue: No ]
  • Presence of Candida hyphae or blastospores [ Time Frame: at all visits during 12 weeks except screening ] [ Designated as safety issue: No ]
  • Global assessment of efficacy [ Time Frame: visits C1 to C4 during 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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;

  Eligibility

Ages Eligible for Study:   52 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370551

Locations
Belgium
University Hospital Leuven
Leuven, Belgium
Germany
Department of Obstetrics and Gynaecology, University of Regensburg
Regensburg, Germany
Sponsors and Collaborators
Medinova AG
Investigators
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
  More Information

No publications provided

Responsible Party: Medinova AG
ClinicalTrials.gov Identifier: NCT01370551     History of Changes
Other Study ID Numbers: 806109
Study First Received: May 10, 2011
Last Updated: August 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrophic Vaginitis
Vaginitis
Atrophy
Breast Neoplasms
Breast Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Pathological Conditions, Anatomical
Skin Diseases
Vaginal Diseases

ClinicalTrials.gov processed this record on November 20, 2014