Wat zijn de effecten van het middel Duogestan® op de kwaliteit van leven?

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.

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.