N/A
N=85,109
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00335257 ↗Enrolled (actual)
85,109
Serious AEs
6.9%
Results posted
Nov 2014
Primary outcome: Primary: Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs — 19; 16; 101; 7 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
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs |
19; 16; 101; 7; 19 | — |
| PRIMARY Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs |
4; 3; 30; 2; 7; 2 | — |
Summary
The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations.
Eligibility Criteria
Inclusion Criteria
- First-ever OC users ("starters")
- Women switching OC use without a pill intake break ("switchers")
- Recurrent users with a pill intake break ("recurrent users")
- Women willing to participate in the active surveillance
Exclusion Criteria
- Women who do not agree to participate
- Long-term users
Data sourced from ClinicalTrials.gov (NCT00335257). 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.