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.
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
APC-resistance.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Skin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive.
Publiek
P.O. Box 9600
Bea Hiemstra
Leiden 2300 RC
The Netherlands
+31 (0)71 5262871
B.Hiemstra@lumc.nl
Wetenschappelijk
P.O. Box 9600
Bea Hiemstra
Leiden 2300 RC
The Netherlands
+31 (0)71 5262871
B.Hiemstra@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Healthy female volunteers from 18-45 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
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 | NL368 |
NTR-old | NTR408 |
Ander register | : N/A |
ISRCTN | ISRCTN54277211 |