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

Atrophic Vaginitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370551
• Other study ID #: 806109
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2011
• Last updated: August 21, 2012
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2011
• Source: Medinova AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 52 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Atrophy
• Vaginitis

Intervention

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;

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven
Germany	Department of Obstetrics and Gynaecology, University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Medinova AG

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Calculation of pharmacokinetic parameters: AUC0-24, intraindividual mean, Cmax and tmax		on days 1 and 28	Yes
Secondary	Baseline / trough serum concentrations of estriol, estradiol, estrone, FSH, LH and SHBG		at all visits during 12 weeks	No
Secondary	Vaginal pH		at all visits during 12 weeks	No
Secondary	Clinical symptoms and signs		at all visits during 12 weeks	No
Secondary	Vaginal maturation index		at all visits during 12 weeks except screening	No
Secondary	Lactobacillary grade		at all visits during 12 weeks except screening	No
Secondary	Bacterial vaginosis (BV) score		at all visits during 12 weeks except screening	No
Secondary	Aerobic vaginitis (AV) score		at all visits during 12 weeks except screening	No
Secondary	Presence of Candida hyphae or blastospores		at all visits during 12 weeks except screening	No
Secondary	Global assessment of efficacy		visits C1 to C4 during 12 weeks	No