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

Primary Purpose

Atrophic Vaginitis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Gynoflor
Sponsored by
Medinova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Vaginitis

Eligibility Criteria

52 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Leuven
  • Department of Obstetrics and Gynaecology, University of Regensburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gynoflor

Arm Description

This study consists only of this arm.

Outcomes

Primary Outcome Measures

Serum concentrations of estriol (E3), estradiol (E2), estrone (E1)
Calculation of pharmacokinetic parameters: AUC0-24, intraindividual mean, Cmax and tmax

Secondary Outcome Measures

Baseline / trough serum concentrations of estriol, estradiol, estrone, FSH, LH and SHBG
Vaginal pH
Clinical symptoms and signs
Vaginal maturation index
Lactobacillary grade
Bacterial vaginosis (BV) score
Aerobic vaginitis (AV) score
Presence of Candida hyphae or blastospores
Global assessment of efficacy

Full Information

First Posted
May 10, 2011
Last Updated
August 21, 2012
Sponsor
Medinova AG
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1. Study Identification

Unique Protocol Identification Number
NCT01370551
Brief Title
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Acronym
Gynoflor
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medinova AG

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gynoflor
Arm Type
Experimental
Arm Description
This study consists only of this arm.
Intervention Type
Drug
Intervention Name(s)
Gynoflor
Intervention Description
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 Measure Information:
Title
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
Title
Calculation of pharmacokinetic parameters: AUC0-24, intraindividual mean, Cmax and tmax
Time Frame
on days 1 and 28
Secondary Outcome Measure Information:
Title
Baseline / trough serum concentrations of estriol, estradiol, estrone, FSH, LH and SHBG
Time Frame
at all visits during 12 weeks
Title
Vaginal pH
Time Frame
at all visits during 12 weeks
Title
Clinical symptoms and signs
Time Frame
at all visits during 12 weeks
Title
Vaginal maturation index
Time Frame
at all visits during 12 weeks except screening
Title
Lactobacillary grade
Time Frame
at all visits during 12 weeks except screening
Title
Bacterial vaginosis (BV) score
Time Frame
at all visits during 12 weeks except screening
Title
Aerobic vaginitis (AV) score
Time Frame
at all visits during 12 weeks except screening
Title
Presence of Candida hyphae or blastospores
Time Frame
at all visits during 12 weeks except screening
Title
Global assessment of efficacy
Time Frame
visits C1 to C4 during 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 STDs (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 AIs Previous participation in this study Patient is a relative of, or staff directly reporting to the investigator Patient is an employee of the sponsor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Neven, Prof. Dr.
Organizational Affiliation
University Hospital Leuven, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Buchholz, PD Dr.
Organizational Affiliation
Department of Obstetrics and Gynaecology, University of Regensburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilbert Donders, Prof. Dr.
Organizational Affiliation
Femicare, University Hospital, Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Leuven
City
Leuven
Country
Belgium
Facility Name
Department of Obstetrics and Gynaecology, University of Regensburg
City
Regensburg
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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