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

Sponsor
Medinova AG (Industry)
Overall Status
Completed
CT.gov ID
NCT01370551
Collaborator
(none)
16
Enrollment
2
Locations
1
Arm
15
Duration (Months)
8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
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 :
Apr 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

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;

Outcome Measures

Primary Outcome Measures

  1. Serum concentrations of estriol (E3), estradiol (E2), estrone (E1) [-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 [on days 1 and 28]

Secondary Outcome Measures

  1. Baseline / trough serum concentrations of estriol, estradiol, estrone, FSH, LH and SHBG [at all visits during 12 weeks]

  2. Vaginal pH [at all visits during 12 weeks]

  3. Clinical symptoms and signs [at all visits during 12 weeks]

  4. Vaginal maturation index [at all visits during 12 weeks except screening]

  5. Lactobacillary grade [at all visits during 12 weeks except screening]

  6. Bacterial vaginosis (BV) score [at all visits during 12 weeks except screening]

  7. Aerobic vaginitis (AV) score [at all visits during 12 weeks except screening]

  8. Presence of Candida hyphae or blastospores [at all visits during 12 weeks except screening]

  9. Global assessment of efficacy [visits C1 to C4 during 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
52 Years to 75 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Leuven Leuven Belgium
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medinova AG
ClinicalTrials.gov Identifier:
NCT01370551
Other Study ID Numbers:
  • 806109
First Posted:
Jun 10, 2011
Last Update Posted:
Aug 22, 2012
Last Verified:
Jan 1, 2011
Additional relevant MeSH terms:
Vaginitis
Atrophic Vaginitis
Atrophy

Study Results

No Results Posted as of Aug 22, 2012