Wat zijn de effecten van het middel Duogestan® op de kwaliteit van leven?
- Conditions
- Menopause, menopauze, overgang
- Registration Number
- NL-OMON22707
- Lead Sponsor
- Besins Healthcare
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
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;
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):
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary objectives include the bleeding pattern, the menopausal symptoms and the evaluation of safety and tolerability of Duogestan ® treatment.