No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
APC-resistance.
Secondary outcome
Other coagulation factors.
Background summary
The 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.
Study objective
The 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.
Study design
N/A
Intervention
Skin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive.
P.O. Box 9600
Bea Hiemstra
Leiden 2300 RC
The Netherlands
+31 (0)71 5262871
B.Hiemstra@lumc.nl
P.O. Box 9600
Bea Hiemstra
Leiden 2300 RC
The Netherlands
+31 (0)71 5262871
B.Hiemstra@lumc.nl
Inclusion criteria
Healthy female volunteers from 18-45 years.
Exclusion criteria
1. 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.
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 | NL368 |
| NTR-old | NTR408 |
| Other | : N/A |
| ISRCTN | ISRCTN54277211 |