check_circleStudy Completed

Contraception

Bayer Identifier:

13760

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • -

  • -

Trial summary

Enrollment Goal
85109
Trial Dates
August 2005 - February 2013
Phase
N/A
Could I Receive a placebo
N/A
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
N/A

Primary Outcome

  • Risks of short- and long-term use of DRSP24d
  • Risks of short- and long-term use of established OCs
  • DRSP24d comparison to levonorgestrel-containing OCs

Secondary Outcome

  • General safety, contraceptive effectiveness and the drug utilization pattern of DRSP24d, as well as the baseline risk for users of individual OC formulations

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
N/A

Additional Information

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