Long-term Active Surveillance Study for Oral Contraceptives (LASS)

NCT00676065 | Completed Results DMC

• 1 other identifier: ZEG2006_03
• Study Type: observational
• Target: 58,303
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arterial Thromboembolism; Venous Thromboembolism; Breast Cancer

Keywords

Contraception; Thromboembolism; Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Arterial Thromboembolism

  Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

  Within 10 years

• Venous Thromboembolism

  Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

  Within 10 years

• Breast Cancer

  Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.

  Within 10 years

Study Arms (3)

1

Women who take oral contraceptives containing drospirenone

2

Women who take oral contraceptives containing levonorgestrel

3

Women who take oral contraceptives containing other progestogens

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 attending offices of oral contraceptives prescribing physicians

You may qualify if:

• Women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation

You may not qualify if:

• Women who do not consent to participate in the study

Sponsors & Collaborators

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

Study Sites (1)

Center for Epidemiology and Health Research

Berlin, Germany

Location

Related Publications (1)

• Dinger J, Mohner S, Heinemann K. Cardiovascular risks associated with the use of drospirenone-containing combined oral contraceptives. Contraception. 2016 May;93(5):378-85. doi: 10.1016/j.contraception.2016.01.012. Epub 2016 Jan 26.

  PMID: 26825258 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Breast Neoplasms; Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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

+49 30 945 101 20

Study Officials

• Juergen 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: May 8, 2008
• First Posted: May 12, 2008
• Study Start: February 1, 2001
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 19, 2014
• Results First Posted: November 19, 2014

Record last verified: 2014-11

Locations

DE (1)