Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-22

Study Completion Date

2020-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

NCT04232813

Vulvovaginal Atrophy

COMPLETED PHASE3

To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.

NCT02668796

Vulvar and Vaginal Atrophy

COMPLETED PHASE3

Efficacy of Gynodian® Depot in Women With Impaired Well-being

NCT00463450

Hormone Replacement Therapy

COMPLETED PHASE3

Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy

NCT02967510

Vaginal Atrophy

COMPLETED PHASE2

Vaginal and Urinary Microbiome Trial

NCT02869165

Atrophic Vaginitis Menopause Recurrent Urinary Tract Infections

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrophy of Vagina Postmenopause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gynoflor

1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday) for 6 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No