EV(E)A StudieEstriol versus Estradiol - Eine prospektive, randomisierte Multizenterstudie zur Evaluation der Wirkung einer lokalen Therapie auf urogenitale Beschwerden, Zytologie und Mammographiedichte

Phase 1

• Conditions: vaginal atrophy in postmenopausal women; MedDRA version: 9.1Level: LLTClassification code 10015504Term: Estriol; MedDRA version: 9.1Level: LLTClassification code 10015499Term: Estradiol

• Registration Number: EUCTR2008-003120-37-DE
• Lead Sponsor: Medizinische Fakultät der Otto von Guericke Universität Magdeburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-06
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

postmenopausal women
vaginal atrophy
mammogram without pathological findings
vaginal cytology without pathological findings
informed consent
age not older than 75 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

gynecological malignant tumor
systemic therapy with hormons (estrogens, androgens) (within the last 6 months)
lokale therapy with estrogens (within the last 6 weeks)
therapy with phytoestrogens (within the last 3 months; the use longer then 3 months is permitted but must be continued during the trail)
Lichen sclerosus et atrophicans
Dermatological disease (z.B. severe acne) or drug eruption
cerebrovasculare disease, thromboembolic disease, heart attac, angina pectoris or thrombophlebitis (within the last 5 years)
akute liver oder kidney disease or other severe disease (within the last 6 months)
postmenopausal bleeding
vaginale infection
breast surgery within the last 6 months
porphyria
endometrial hyperplasia
seizure
known allergy to the IMPs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The trial compares the effectiveness of estriol and estradiol for women who suffer from vaginal atrophy;Secondary Objective: Secondarily the trail investigates the influence of the local therapy with estriol and estradiol on the density of parenchyma of the breast by comparing mammograms before and after therapy.;Primary end point(s): improvement of vaginale symptoms like dryness, dyspareunia, bladder infections, incontinence, pruritus