Menopause and female climacteric states MedDRA version: 8.1 Level: LLT Classification code 10027308 Term: Menopause
Conditions
Interventions
Trade Name: Presomen® 0,6/5 mg compositum
Pharmaceutical Form: Coated tablet
INN or Proposed INN: conjugated equine estrogens 0.6 mg
Pharmaceutical form of the placebo: Coated tablet
Route of administ
Sponsors
Ludwig-Maximilians-Universitaet Muenchen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women aged 55 to 69: - who are on menopausal HT for at least three years - who are currently taking Presomen® 0.6mg/ 5mg compositum or Presomen® 28 compositum 0.3 mg/5 mg - who have good knowledge of German for filling in the questionnaires - who have had a mammography in the last year or will have one before starting intake of medication - who have signed the informed consent - who intend to continue on HT for at least 6 months 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: Women who: - have had hysterectomy - who have known, suspected, or history of breast cancer - who have history or existing venous thromboembolism - who have had previous acute heart disease or stroke - who have active or history of liver dysfunction or disease - who have known or suspected estrogen-dependent neoplasia (particularly cancer of the endometrium) - who have untreated endometrial hyperplasia - who have undiagnosed abnormal genital bleeding - who have porphyry - who have terminal renal insufficiency - or who are participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the withdrawal effect from long-term (>=3 years) postmenopausal HT. Measures on health-related QoL and psychological well-being among women aged 55 to 69 will be taken.;Secondary Objective: Evaluation of the withdrawal effects from HT in: vasomotor, somatic and psychological symptoms, libido, sleep quality, anxiety and depression symptoms and life satisfaction.;Primary end point(s): Mean scores of health-related quality of life questionnaire 6 months after baseline as measured with the Medical Outcomes Study 36-item Short Form General Health Survey (SF-36). | — |
Countries
Germany
Outcome results
None listed