Trial Condition(s):
Contraception
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) (INAS-OC)
Bayer Identifier:
13760
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Primary objective(s):
• To assess the risks of short- and long-term use of DRSP24d and of established OCs in a study population that is representative for the actual users of the individual preparations.
• In a sub-analysis DRSP24d is compared to levonorgestrel-containing OCs.
Secondary objective(s):
• General safety, contraceptive effectiveness and the drug utilization pattern of DRSP24d, as well as the baseline risk for users of individual OC formulations.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status |
|---|
Trial Design
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Risks of short- and long-term use of DRSP24dTimeframe:
- Risks of short- and long-term use of established OCsTimeframe:
- DRSP24d comparison to levonorgestrel-containing OCsTimeframe:
Secondary Outcome
- General safety, contraceptive effectiveness and the drug utilization pattern of DRSP24d, as well as the baseline risk for users of individual OC formulationsTimeframe:
Additional Information
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