The dienogest/estradiolvalerate containing oral contraceptive is more thrombogenic than the levonorgestrel/ethinylestradiol containing oral contraceptive (microgynon-30).
ID
Bron
Aandoening
Veneuze trombose, venous thrombosis.
Anticonceptie, contraception
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Sex-Hormone Binding Globulin (SHBG) and Activated Protein C-resistance (APC-resistance).
Achtergrond van het onderzoek
To 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.
Doel van het onderzoek
The dienogest/estradiolvalerate containing oral contraceptive is more thrombogenic than the levonorgestrel/ethinylestradiol containing oral contraceptive (microgynon-30).
Onderzoeksopzet
1. Baseline;
2. 4x in the third cycle on day 2, 7, 24, 26 of the pill-cycle.
Onderzoeksproduct en/of interventie
Use of Qlaira or Microgynon-30 during 3 cycles.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Competent women, 18-35 years with the wish to use an oral contraceptive (Qlaira or Microgynon-30).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2228 |
| NTR-old | NTR2354 |
| Ander register | CME LUMC : P10.041 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |