N/A
N=58,303
Long-term Active Surveillance Study for Oral Contraceptives (LASS)
Arterial Thromboembolism · Venous Thromboembolism · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00676065 ↗Enrolled (actual)
58,303
Serious AEs
13.7%
Results posted
Nov 2014
Primary outcome: Primary: Arterial Thromboembolism — 7; 22; 34 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Center for Epidemiology and Health Research, Germany
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arterial Thromboembolism |
7; 22; 34 | — |
| PRIMARY Venous Thromboembolism |
56; 53; 144 | — |
| PRIMARY Breast Cancer |
27; 31; 45 | — |
Summary
The objective of this study is to characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives.
Eligibility Criteria
Inclusion Criteria
- Women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation
Exclusion Criteria
- Women who do not consent to participate in the study
Data sourced from ClinicalTrials.gov (NCT00676065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.