International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)

NCT00335257 | Completed Results DMC

• 1 other identifier: ZEG 2005-2
• Study Type: observational
• Target: 85,109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Keywords

Drospirenone; Safety; INAS

Outcome Measures

Primary Outcomes (2)

• Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs

  Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.

  Within 60 months

• Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs

  Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.

  Within 60 months

Study Arms (2)

1

Users of OCs containing DRSP

2

Users of OCs containing other progestins

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women using oral contraceptives

You may qualify if:

• 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

You may not qualify if:

• Women who do not agree to participate
• Long-term users

Sponsors & Collaborators

• Center for Epidemiology and Health Research, Germany: lead
• Bayer: collaborator

Study Sites (1)

Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

Related Publications (2)

• Dinger J, Bardenheuer K, Heinemann K. Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives. Contraception. 2014 Apr;89(4):253-63. doi: 10.1016/j.contraception.2014.01.023. Epub 2014 Feb 4.

  PMID: 24576793 DERIVED

• Dinger J, Do Minh T, Buttmann N, Bardenheuer K. Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen. Obstet Gynecol. 2011 Jan;117(1):33-40. doi: 10.1097/AOG.0b013e31820095a2.

  PMID: 21213475 DERIVED

Limitations and Caveats

In non-experimental studies the possibility of bias and residual confounding can never be entirely eliminated. The findings may exclude large, but not small relative risks.

Results Point of Contact

• Title: Juergen Dinger, MD, PhD
• Organization: Center for Epidemiology and Health Research, Germany

dinger@zeg-berlin.de

0049(0)30 945 10120

Study Officials

• Juergen C Dinger, MD, PhD

  Center for Epidemiology and Health Research, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 9, 2006
• Study Start: August 1, 2005
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 7, 2019
• Results First Posted: November 18, 2014

Record last verified: 2019-08

Locations

DE (1)