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


- candidate number5237
- NTR NumberNTR1648
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jan-2009
- Secondary IDs08-2-130 MEC Maastricht
- Public TitleWat zijn de effecten van het middel Duogestan® op de kwaliteit van leven?
- Scientific TitleWomen’s Hormonal Intervention Study in early Postmenopause of Estradiol-progesterone Replacement therapy - effects on quality of life.
- ACRONYMWHISPER-1
- hypothesisDuogestan® leidt in symptomatische, vroeg postmenopausale vrouwen tot een verbetering in kwaliteit van leven van 20%.
- Healt Condition(s) or Problem(s) studiedMenopause
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate30-jun-2012
- Target number of participants100
- InterventionsDuogestan® (hormone replacement therapy).
- Primary outcomeThe 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 outcomeSecondary objectives include the bleeding pattern, the menopausal symptoms and the evaluation of safety and tolerability of Duogestan ® treatment.
- TimepointsThere will be a total of 6 visits. The first visit being the screening and the following 5 visits being measuring moments.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES T. Ekhart
- CONTACT for SCIENTIFIC QUERIESdrs. C.A.H. Rijvers
- Sponsor/Initiator Besins Healthcare
- Funding
(Source(s) of Monetary or Material Support)
Besins Healthcare
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD30-jan-2009 - 14-sep-2009


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