No registrations found.
ID
Source
Health condition
Veneuze trombose, venous thrombosis.
Anticonceptie, contraception
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sex-Hormone Binding Globulin (SHBG) and Activated Protein C-resistance (APC-resistance).
Secondary outcome
N/A
Background summary
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.
Study objective
The dienogest/estradiolvalerate containing oral contraceptive is more thrombogenic than the levonorgestrel/ethinylestradiol containing oral contraceptive (microgynon-30).
Study design
1. Baseline;
2. 4x in the third cycle on day 2, 7, 24, 26 of the pill-cycle.
Intervention
Use of Qlaira or Microgynon-30 during 3 cycles.
Inclusion criteria
Competent women, 18-35 years with the wish to use an oral contraceptive (Qlaira or Microgynon-30).
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2228 |
| NTR-old | NTR2354 |
| Other | CME LUMC : P10.041 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |