The thrombogenicity of the dienogest/estradiol valerate-containing oral contraceptive (Qlaira®)
Completed
- Conditions
- blood clotVenous thrombosis10064477
- Registration Number
- NL-OMON35104
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Women, age 18-35 years, the wish to use dienogest/estradiol valerate or levonorgestrel/ethinylestradiol as oral contraceptive.
Exclusion Criteria
People who are legally incapable, contra-indications for the use of oral contraceptives as described by the WHO and Dutch Society of Gynaecologists, pregnancy during or in the three months before the trial, use of medication which can influence coagulation, chronic/acute illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Thrombin generation based-APC-resistance and SHBG.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Factor V Leiden and prothrombin mutation.</p><br>
Related Research Topics
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What molecular mechanisms of dienogest and estradiol valerate in Qlaira® influence thrombogenicity in venous thrombosis patients?
How does Qlaira® compare to standard-of-care COCs in terms of venous thromboembolism risk and efficacy profiles?
Are there specific biomarkers associated with Qlaira®'s effectiveness in reducing blood clot formation in reproductive-aged women?
What are the potential adverse events linked to dienogest/estradiol valerate COCs and how are they managed in clinical practice?
How do third-generation progestins like dienogest in Qlaira® compare to other HRT formulations in terms of thrombotic risk profiles?