vaginal atrophy in postmenopausal women MedDRA version: 9.1 Level: LLT Classification code 10015504 Term: Estriol MedDRA version: 9.1 Level: LLT Classification code 10015499 Term: Estradiol
Conditions
Interventions
Product Name: Estradiol
Pharmaceutical Form: Tablet for vaginal solution
INN or Proposed INN: ESTRADIOL
CAS Number: 50282
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Medizinische Fakultät der Otto von Guericke Universität Magdeburg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed