Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women

Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women

Study Overview

• Status: Completed
• Conditions: Postmenopause; Atrophy of Vagina
• Intervention / Treatment: Drug: Gynoflor

Detailed Description

Within this trial 50 postmenopausal women receive a vaginal estrogen therapy as treatment for symptomatic vaginal atrophy. The sustainability of vaginal estrogen therapy after the end of therapy has not yet been investigated.

All participants will be asked to come for the following 7 visits.

• Visit 1: Standard Gynecological examination; Inclusion and exclusion criteria check
• Visit 2: Handing out of Gynoflor (estrogen) for a 6 weeks treatment.
• Visit 3 (Study Start): After using the vaginal estrogen for 6 weeks, a vaginal swap will be done to measure the vaginal maturation index (VMI). The participants will also receive a questionnaire to define some subjective parameters. The parameters measured at visit 1 will count as reference. The estrogen therapy will now be sustained.
• Visit 4-6: Measuring of the VMI and handing out the questionnaires to define subjective parameters.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

postmenopausal women

Description

Inclusion Criteria:

• Postmenopausal women (last menstrual period more than 12 months ago or having undergone bilateral ovariectomy)
• Age ≥ 18 years
• Diagnosis of moderate to severe vaginal atrophy at screening visit with VMI < 50% and vaginal pH > 4.5
• At least one subjective symptom of vaginal atrophy (dryness, pain/burning sensation, pruritus, discharge, dyspareunia) related to a score of ≥ 65 on the visual analogue scale (VAS)
• Indication for vaginal treatment with Gynoflor® (100 million viable L. acidophilus KS 400 and estriol 30 mcg per application) for 6 weeks because of symptomatic vaginal atrophy after menopause: 1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday).
• Informed consent as documented by signature

Exclusion Criteria:

• Administration of any form of oral/transdermal hormone therapy (HT) or selective estrogen receptor modulators (SERM) or phytoestrogens within 2 months prior to entry into or during the study.
• Any use of over-the-counter vaginal products within 1 week prior to and during entry the study.
• Known hypersensitivity or allergy to the investigational product
• Estrogen dependent malignancy
• Undiagnosed genital bleeding
• Active thromboembolism
• Active vulvovaginal Candidiasis, Trichomonas vaginitis or bacterial vaginitis based on light microscopy of vaginal secretions, vaginal pH, whiff test and KOH preparation
• Active sexually transmitted infections (STI) including herpes simplex viral infection, gonorrhoea and Chlamydia.
• Active urinary tract infection.
• Pessary-users
• Immunocompromised patients including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents
• Severe liver and/or kidney disease
• Diabetes mellitus
• Polyneuropathy
• Skin disease affecting vulva or vagina, e.g. lichen sclerosus
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in vaginal maturation index (VMI)	0 weeks, 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in VMI	0 weeks,1 week, 2 weeks, 6 weeks
Mean change in vaginal pH	0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Number of lactobacilli	0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Lactobacillary grade (LBG),	0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Mean change in the most bothersome moderate and severe symptom of vaginal atrophy (MBS) . The symptoms include dryness, pain/burning sensation, pruritus, discharge, and dyspareunia.	0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Mean change in health-related quality of life (EQ-5D-5L). Mean change in Female Sexual Function Index (FSFI).	0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Medinova AG
• Investigators: Principal Investigator: Petra Stute, Prof, University Hospital Berne

Publications and helpful links

General Publications

• Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
• McEndree B. Clinical application of the vaginal maturation index. Nurse Pract. 1999 Sep;24(9):48, 51-2, 55-6.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): April 10, 2020

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 2016-00380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No