The thrombogenicity of the dienogest/estradiol valerate containing oral contraceptive (Qlaira)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018590-38-NL

Enrollment

Registered

2010-02-17

Start date

2010-04-14

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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. MedDR

Interventions

Trade Name: Qlaira Product Name: Qlaira Product Code: RVG 101491 Pharmaceutical Form: Tablet INN or Proposed INN: DIENOGEST CAS Number: 65928-58-7 Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To predict the thrombogenicity of a new oral contraceptive composed of dienogest/ethinylestradiol in comparison to an oral contraceptive with a low thrombotic risk, composed of levonorgstrel/ethinylestradiol. ;Secondary Objective: There is no secondary objective.;Primary end point(s): Thrombin generation-based APC-resistance and SHBG as predictors for the risk of venous thromboembolism in women using dienogest/estradiol valerate oral contraceptives or levonorgestrel/ethinylestradiol.	—

Measure

Time frame

Main Objective: To predict the thrombogenicity of a new oral contraceptive composed of dienogest/ethinylestradiol in comparison to an oral contraceptive with a low thrombotic risk, composed of levonorgstrel/ethinylestradiol. ;Secondary Objective: There is no secondary objective.;Primary end point(s): Thrombin generation-based APC-resistance and SHBG as predictors for the risk of venous thromboembolism in women using dienogest/estradiol valerate oral contraceptives or levonorgestrel/ethinylestradiol.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026