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Trial record 72 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

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

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ClinicalTrials.gov Identifier: NCT00335257
Recruitment Status : Completed
First Posted : June 9, 2006
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

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.

Condition or disease
Contraception

Detailed Description:

Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. This study investigates the risks of short and long-term use of a 24-day regimen of drospirenone/ethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations.

INAS-OC is a prospective, controlled, non-interventional cohort study with two study arms: OCs containing drospirenone and OCs containing any other progestogen. The study was started in the USA in April 2005 and was extended to several European countries in September 2008 based on the launch status of the 24-day regimen. New users of an OC (starters, switchers without a pill intake break and recurrent users with a pill intake break [same or different OC]) are accrued by a network of prescribing physicians. Baseline and follow-up information are collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts. All analyses will make allowance for confounding, using methods that will include multivariate techniques such as Cox regression.


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Study Type : Observational
Actual Enrollment : 85109 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)
Study Start Date : August 2005
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Group/Cohort
1
Users of OCs containing DRSP
2
Users of OCs containing other progestins



Primary Outcome Measures :
  1. Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs [ Time Frame: Within 60 months ]
    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.

  2. Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs [ Time Frame: Within 60 months ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women using oral contraceptives
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335257


Locations
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Germany
Center for Epidemiology and Health Research
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
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Principal Investigator: Juergen C Dinger, MD, PhD Center for Epidemiology and Health Research, Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00335257     History of Changes
Other Study ID Numbers: ZEG 2005-2
First Posted: June 9, 2006    Key Record Dates
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany:
Drospirenone
Safety
INAS

Additional relevant MeSH terms:
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Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female