Menopause, menopauze, overgang
Conditions
Interventions
Duogestan® (hormone replacement therapy).
Sponsors
Besins Healthcare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women: last menstrual period between 6 months and maximum 5 years ago, FSH levels > 35 IU/L and estradiol levels < 20 picograms/mL (cut offs defined by central laboratory: “Klinisch Chemisch Laboratorium” at MUMC); 2. Positive progesterone challenge test; 3. Endometrium thickness less than 5 mm; 4. Age between 45-55 years; 5. Menopausal discomfort, more specifically hot flushes (2 or more hot flushes per day since at least three months); 6. Intact uterus.
Exclusion criteria
Exclusion criteria: 1. Previous use of any hormone replacement therapy for a duration of more than 3 years; 2. 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): A. Ritonavir and nelfinavir; B. Herbal preparations containing St. John’s Wort (Hypericum perforatum); 3. Known contra-indications for Duogestan®: A. Known, past or suspected breast cancer; B. Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer); C. Undiagnosed genital bleeding; D. Untreated endometrial hyperplasia; E. Previous idiopathic or current venous trhomboembolism (deep vein thrombosis, pulmonary embolism); F. Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction); G. Acute liver disease or a history of liver disease, until liver function tests have returned to normal; H. Known hypersensitivity to the active substances or to any of the excipients; I. Porphyria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to assess if Duogestan ® can lead to a 20% improvement of the health related quality of life compared to baseline. We will explore the overall quality of life, as well as the individual components of the quality of life questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include the bleeding pattern, the menopausal symptoms and the evaluation of safety and tolerability of Duogestan ® treatment. | — |
Contacts
Public ContactT. Ekhart
Academisch Ziekenhuis Maastricht Secr. Obstetrie/gynaecologie Postbus 5800
Outcome results
None listed