Menopause
Conditions
Interventions
Each patient will receive 13 cycles of 28 days Duogestan® (1mg micronized 17 *-
E2, 200mg micronized progesterone (P4)) or 6 cycles placebo followed by 7
cycles Duogestan®, each cycle consisting of 2
Sponsors
Obstetrie & Gynaecologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women: last menstrual period between 6 months and maximum 2 years ago, FSH levels > 35 IU/L and estradiol levels
Exclusion criteria
Exclusion criteria: 1. Previous use of any hormone replacement therapy; except the use of estriol or phyto-estrogens 2. BMI > 35 3. Use of oral contraceptives during the last 2 months 4. Use of hormonal intra uterine device or implant during the last 2 months 5. Known contra-indications for Duogestan®: - Known, past or suspected breast cancer; - Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer); - Undiagnosed genital bleeding; - Untreated endometrial hyperplasia; - Previous idiopathic or current venous trhomboembolism (deep vein thrombosis, pulmonary embolism); - Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction); - Acute liver disease or a history of liver disease, until liver function tests have returned to normal; - Known hypersensitivity to the active substances or to any of the excipients; - Porphyria 6. Use of medication known to interact with 17 ß-estradiol or micronized progesterone; - Substances known to induce drug-metabolising enzymes, particularly anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, fifabutin, nevirapine, efavirenz) - Ritonavir and nelfinavir - Herbal preparations containing St. John*s Wort (Hypericum perforatum) 7. Participation in an investigational study within 30 days prior to administration of the study medication
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Bleeding patterns will be assessed by a bleeding-diary. | — |
Primary
| Measure | Time frame |
|---|---|
| Health related QoL will be assessed by the Dutch validated versions of the Women*s Health Questionnaire (WHQ) and the European Quality of life instrument (EuroQol). | — |
Countries
Netherlands
Outcome results
None listed