MedDataX Logo

Trial Outcomes & Findings for Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism (NCT NCT00523614)

NCT ID: NCT00523614

Last Updated: 2010-03-23

Results Overview

The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy.

Recruitment status

COMPLETED

Target enrollment

3400 participants

Primary outcome timeframe

01/2002 - 01/2008

Results posted on

2010-03-23

Participant Flow

Identification started in spring 2007 and ended in January 2008. Cases (VTE=venous thromboembolism diagnosed in Germany between 01/2002 and 01/2008) were identified by primary care physicians. For each case 4 community-based controls (no VTE between 01/2002 and 01/2008) were selected.The controls were identified from randomly selected households.

Participant milestones

Participant milestones
Measure
Cases
Women with a venous thromboembolism who are between 15 and 49 years old
Controls
Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
Overall Study
STARTED
680
2720
Overall Study
COMPLETED
680
2720
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cases
n=680 Participants
Women with a venous thromboembolism who are between 15 and 49 years old
Controls
n=2720 Participants
Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
Total
n=3400 Participants
Total of all reporting groups
Age, Categorical
<=18 years
15 Participants
n=5 Participants
60 Participants
n=7 Participants
75 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
665 Participants
n=5 Participants
2660 Participants
n=7 Participants
3325 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
36.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
36.1 years
STANDARD_DEVIATION 9.0 • n=7 Participants
36.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male
Female
680 Participants
n=5 Participants
2720 Participants
n=7 Participants
3400 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
Germany
680 participants
n=5 Participants
2720 participants
n=7 Participants
3400 participants
n=5 Participants

PRIMARY outcome

Timeframe: 01/2002 - 01/2008

The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy.

Outcome measures

Outcome measures
Measure
Cases
n=680 Participants
Women with a venous thromboembolism who are between 15 and 49 years old
Controls
n=2720 Participants
Women without a venous thromboembolism who are between 15 and 49 years old
Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)
Exposed DNG/EE COC
35 Participants
106 Participants
Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)
Exposed low-dose COC
161 Participants
423 Participants

Adverse Events

Cases

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Controls

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Juergen Dinger, MD, PhD, Principal Investigator

Berlin Center for Epidemiology and Health Research, Germany

Phone: +49 30 94510145

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place