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The risk of venous thrombosis during use of Qlaira (R).


- candidate number8052
- NTR NumberNTR2354
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mei-2010
- Secondary IDsP10.041 CME LUMC
- Public TitleThe risk of venous thrombosis during use of Qlaira (R).
- Scientific TitleThe thrombogenicity of the dienogest/estradiolvalerate-containing oral contraceptive (Qlaira(R)).
- ACRONYM
- hypothesisThe dienogest/estradiolvalerate containing oral contraceptive is more thrombogenic than the levonorgestrel/ethinylestradiol containing oral contraceptive (microgynon-30).
- Healt Condition(s) or Problem(s) studiedVenous thrombosis, Contraception
- Inclusion criteriaCompetent women, 18-35 years with the wish to use an oral contraceptive (Qlaira or Microgynon-30).
- Exclusion criteria1. People who are legally incapable;
2. Contra-indications for the use of oral contraceptives as described by the WHO and Dutch Society of Gynaecologists;
3. Pregnancy in the three months before the trial;
4. Use of medication which can influence coagulation;
5. Chronic/acute illness.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-mei-2011
- Target number of participants80
- InterventionsUse of Qlaira or Microgynon-30 during 3 cycles.
- Primary outcomeSex-Hormone Binding Globulin (SHBG) and Activated Protein C-resistance (APC-resistance).
- Secondary outcomeN/A
- Timepoints1. Baseline;
2. 4x in the third cycle on day 2, 7, 24, 26 of the pill-cycle.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Raps
- CONTACT for SCIENTIFIC QUERIESProf.dr. F.M. Helmerhorst
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryTo determine the risk of venous thrombosis during use of the dienogest/estradiolvalerate oral contraceptive (Qlaira), APC-resistance and SHBG (as surrogate markers for venous thrombosis) will be measured at baseline and after three months of use of the oral contraceptive. We will compare dienogest/estradiolvalerate with levonorgestrel/ethinylestradiol (Microgynon-30). 80 healthy, competent, voluntarily, female persons will be randomized in two groups. The study is not blinded. The first group will use dienogest/estradiolvalerate (Qlaira®) and the second group will use levonorgestrel/ethinylestradiol (Microgynon-30®) during three months. Before the subjects start to use the contraceptives, they have to fill in a survey, and a blood sample will be taken. The contraceptives will be used for three months. In the third month, four blood samples will be taken at day 2, 7, 24 and 26 of the cycle. After these three months, the investigation ends for the subjects. We’ll measure APC-resistance and SHBG in the blood samples in one run, after completion of the blood collection.
- Main changes (audit trail)
- RECORD10-mei-2010 - 15-jun-2010


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