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MEN-Study: A randomized cross-over study on the effects of the skin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive on the anticoagulations pathways.


- candidate number1702
- NTR NumberNTR408
- ISRCTNISRCTN54277211
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR18-sep-2005
- Secondary IDsN/A 
- Public TitleMEN-Study: A randomized cross-over study on the effects of the skin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive on the anticoagulations pathways.
- Scientific TitleA randomized cross-over study on the effects of the skin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive on the anticoagulations pathways.
- ACRONYMMEN-Study (Microgynon 30-EVRA-Nuvaring Study)
- hypothesisThe effect on APC-resistance of the skin patch and the vaginal ring contraceptives, containing third generation gestagens, is significantly increased in comparison with oral contraceptives, containing second generation gestagens.
- Healt Condition(s) or Problem(s) studiedNo condition, healthy person
- Inclusion criteriaHealthy female volunteers from 18-45 years.
- Exclusion criteria1. Underage;
2. Contra-indication for use of the contraceptive ring, skin patch or oral contraceptives, as termed by WHO, NVOG and NHG;
3. Use of hormonal contraception or hormonal substitution therapy 2 months before inclusion;
4. Pregnancy 3 months before inclusion or during the study;
5. Use of medication with effect on the blood coagulation;
6. Chronical or acute diseases;
7. Lupus anticoagulans.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2005
- planned closingdate31-dec-2006
- Target number of participants20
- InterventionsSkin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive.
- Primary outcomeAPC-resistance.
- Secondary outcomeOther coagulation factors.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Bea Hiemstra
- CONTACT for SCIENTIFIC QUERIES Kathrin Fleischer
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Gynaecology
- PublicationsN/A
- Brief summaryThe aim of the study is to observe the differential effects of a second generation oral contraceptive versus the skin patch and the vaginal contraceptive ring, containing third generation gestagens, on activated protein C resistance, determined with a thrombin generation-based test, predicting for venous thrombosis. The study design is a randomised, open label, cross-over study.
- Main changes (audit trail)
- RECORD18-sep-2005 - 14-sep-2009


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