Trial Outcomes & Findings for European Active Surveillance Study (EURAS) (NCT NCT00302848)
NCT ID: NCT00302848
Last Updated: 2009-11-20
Results Overview
Recruitment status
COMPLETED
Target enrollment
59510 participants
Primary outcome timeframe
1.5 to 5 years
Results posted on
2009-11-20
Participant Flow
A total of 59510 women were enrolled. Thereof 836 were excluded as they did not sign the informed consent form, were enrolled two or more times, continued their old OC or did not start OC use. In addition 371 used non oral hormonal contraception at study entry. These women were only used for the comparison of baseline risks.
Participant milestones
| Measure |
Users of Drospirenone (DRSP)
Women who use oral contraceptives (OCs) containing DRSP as progestin
|
Users of Levonorgestrel (LNG)
Women who use oral contraceptives (OCs) containing LNG as progestin
|
Users of Other Oral Contraceptives (OCs)
Women who use oral contraceptives (OCs) containing other progestins
|
|---|---|---|---|
|
Overall Study
STARTED
|
16534
|
15428
|
26341
|
|
Overall Study
COMPLETED
|
16133
|
15009
|
25762
|
|
Overall Study
NOT COMPLETED
|
401
|
419
|
579
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
European Active Surveillance Study (EURAS)
Baseline characteristics by cohort
| Measure |
Users of Drospirenone (DRSP)
n=16534 Participants
Women who use oral contraceptives (OCs) containing DRSP as progestin
|
Users of Levonorgestrel (LNG)
n=15428 Participants
Women who use oral contraceptives (OCs) containing LNG as progestin
|
Users of Other Oral Contraceptives (OCs)
n=26341 Participants
Women who use oral contraceptives (OCs) containing other progestins
|
Total
n=58303 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Categorical
<=18 years
|
3,454 participants
n=5 Participants
|
4,215 participants
n=7 Participants
|
6,307 participants
n=5 Participants
|
13976 participants
n=4 Participants
|
|
Age Categorical
Between 18 and 65 years
|
13,080 participants
n=5 Participants
|
11,213 participants
n=7 Participants
|
20,034 participants
n=5 Participants
|
44327 participants
n=4 Participants
|
|
Age Categorical
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Age Continuous
|
25.9 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
25.1 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
24.8 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
25.2 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Gender
Female
|
16,534 participants
n=5 Participants
|
15,428 participants
n=7 Participants
|
26,341 participants
n=5 Participants
|
58303 participants
n=4 Participants
|
|
Gender
Male
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
16,534 participants
n=5 Participants
|
15,428 participants
n=7 Participants
|
26,341 participants
n=5 Participants
|
58303 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1.5 to 5 yearsPopulation: The primary analysis compares the users of DRSP and LNG. Its results are presented below. The comparison of users of DRSP and OCs containing other progestins was only conducted for exploratory reasons. This secondary analysis showed similar results and is described in more detail in the publication of study results, see "citations".
Outcome measures
| Measure |
Users of DRSP
n=16534 Participants
Women who use authorized oral contraceptives containing DRSP prescribed by their gynecologist
|
Users of LNG
n=15428 Participants
Women who use authorized oral contraceptives containing LNG prescribed by their gynecologist
|
|---|---|---|
|
Number of Participants With Venous Thromboembolism (VTE)
|
26 Participants
|
25 Participants
|
Adverse Events
Users of Drospirenone (DRSP)
Serious events: 965 serious events
Other events: 0 other events
Deaths: 0 deaths
Users of Levonorgestrel (LNG)
Serious events: 1059 serious events
Other events: 0 other events
Deaths: 0 deaths
Users of Other Oral Contraceptives (OCs)
Serious events: 1815 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Users of Drospirenone (DRSP)
n=16534 participants at risk
Women who use oral contraceptives (OCs) containing DRSP as progestin
|
Users of Levonorgestrel (LNG)
n=15428 participants at risk
Women who use oral contraceptives (OCs) containing LNG as progestin
|
Users of Other Oral Contraceptives (OCs)
n=26341 participants at risk
Women who use oral contraceptives (OCs) containing other progestins
|
|---|---|---|---|
|
Infections and infestations
Infectious diseases
|
0.31%
51/16534 • Between 1.5 and 5 years
|
0.31%
48/15428 • Between 1.5 and 5 years
|
0.31%
82/26341 • Between 1.5 and 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasms
|
0.06%
10/16534 • Between 1.5 and 5 years
|
0.08%
12/15428 • Between 1.5 and 5 years
|
0.09%
25/26341 • Between 1.5 and 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasms
|
0.37%
61/16534 • Between 1.5 and 5 years
|
0.41%
64/15428 • Between 1.5 and 5 years
|
0.44%
117/26341 • Between 1.5 and 5 years
|
|
Blood and lymphatic system disorders
Diseases of the blood and blood-forming organs
|
0.02%
3/16534 • Between 1.5 and 5 years
|
0.02%
3/15428 • Between 1.5 and 5 years
|
0.05%
12/26341 • Between 1.5 and 5 years
|
|
Endocrine disorders
Endocrine diseases
|
0.21%
34/16534 • Between 1.5 and 5 years
|
0.30%
47/15428 • Between 1.5 and 5 years
|
0.21%
55/26341 • Between 1.5 and 5 years
|
|
Psychiatric disorders
Psychiatric and neurological diseases
|
0.26%
43/16534 • Between 1.5 and 5 years
|
0.38%
58/15428 • Between 1.5 and 5 years
|
0.41%
109/26341 • Between 1.5 and 5 years
|
|
Eye disorders
Eye diseases
|
0.06%
10/16534 • Between 1.5 and 5 years
|
0.11%
17/15428 • Between 1.5 and 5 years
|
0.10%
27/26341 • Between 1.5 and 5 years
|
|
Cardiac disorders
Cardiovascular diseases
|
0.55%
91/16534 • Between 1.5 and 5 years
|
0.64%
99/15428 • Between 1.5 and 5 years
|
0.65%
171/26341 • Between 1.5 and 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory diseases
|
0.13%
21/16534 • Between 1.5 and 5 years
|
0.18%
27/15428 • Between 1.5 and 5 years
|
0.16%
41/26341 • Between 1.5 and 5 years
|
|
Gastrointestinal disorders
Digestive diseases
|
0.73%
121/16534 • Between 1.5 and 5 years
|
0.80%
124/15428 • Between 1.5 and 5 years
|
0.74%
195/26341 • Between 1.5 and 5 years
|
|
Skin and subcutaneous tissue disorders
Skin diseases
|
0.36%
59/16534 • Between 1.5 and 5 years
|
0.38%
59/15428 • Between 1.5 and 5 years
|
0.46%
120/26341 • Between 1.5 and 5 years
|
|
Musculoskeletal and connective tissue disorders
Diseases of the musculoskeletal system
|
0.91%
151/16534 • Between 1.5 and 5 years
|
1.1%
162/15428 • Between 1.5 and 5 years
|
0.99%
261/26341 • Between 1.5 and 5 years
|
|
Renal and urinary disorders
Genitourinary diseases
|
0.55%
91/16534 • Between 1.5 and 5 years
|
0.61%
94/15428 • Between 1.5 and 5 years
|
0.68%
178/26341 • Between 1.5 and 5 years
|
|
Injury, poisoning and procedural complications
Injuries
|
1.2%
192/16534 • Between 1.5 and 5 years
|
1.3%
207/15428 • Between 1.5 and 5 years
|
1.4%
372/26341 • Between 1.5 and 5 years
|
|
General disorders
Other
|
0.16%
27/16534 • Between 1.5 and 5 years
|
0.25%
38/15428 • Between 1.5 and 5 years
|
0.19%
50/26341 • Between 1.5 and 5 years
|
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
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place