The thrombogenicity of the dienogest/estradiol valerate containing oral contraceptive (Qlaira)
- Conditions
- We will investigate the thrombogenicity of two different oral contraceptives: dienogest/estradiol valerate (Qlaira) in comparison to levonorgestrel/ethinylestradiol (Microgynon-30) used by healthy adult women. To predict the thrombogenicity of the two pills we will measure thormbin generation-based Activated Protein C resistance (nAPCsr) and Sex Hormone Binding Globuline (SHBG) in women randomised to dienogest/estradiol valerate or levonorgestrel/ethinylestradiol oral contraceptive pills.MedDRA version: 12.1Level: LLTClassification code 10030971Term: Oral contraceptive
- Registration Number
- EUCTR2010-018590-38-NL
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
Women, age 18-35 years, the wish to use dienogest/estradiol valerate or levonorgestrel/ethinylestradiol as an oral contraceptive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 in the three months before the trial, use of medication which can influence coagulation, chronic/acute illness.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method