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Trial record 72 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00335257
Recruitment Status : Completed
First Posted : June 9, 2006
Results First Posted : November 18, 2014
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

Tracking Information
First Submitted Date June 8, 2006
First Posted Date June 9, 2006
Results First Submitted Date November 6, 2014
Results First Posted Date November 18, 2014
Last Update Posted Date August 7, 2019
Study Start Date August 2005
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00335257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
Official Title International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women using oral contraceptives
Condition Contraception
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Users of OCs containing DRSP
  • 2
    Users of OCs containing other progestins
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 14, 2014)
85109
Original Enrollment
 (submitted: June 8, 2006)
50000
Actual Study Completion Date March 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00335257
Other Study ID Numbers ZEG 2005-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Study Sponsor Center for Epidemiology and Health Research, Germany
Collaborators Bayer
Investigators
Principal Investigator: Juergen C Dinger, MD, PhD Center for Epidemiology and Health Research, Berlin, Germany
PRS Account Center for Epidemiology and Health Research, Germany
Verification Date August 2019