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A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.

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: NCT00196352
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 8, 2014
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date April 8, 2014
Study Start Date  ICMJE May 2003
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
Patient and Investigator reports of adverse events [ Time Frame: Duration of Study ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Patient and Investigator reports of adverse events
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
Official Title  ICMJE A Prospective, Multiple Site Study to Evaluate the Safety of an Extended Cycle Combination Oral Contraceptive, Seasonique, Which Utilizes Ethinyl Estradiol During the Pill-free Interval.
Brief Summary This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.
Detailed Description This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
1 tablet daily
Other Name: Seasonique
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2008)
320
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
400
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00196352
Other Study ID Numbers  ICMJE PSE-304
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duramed Protocol Chair, Duramed Research, Inc.
Study Sponsor  ICMJE Duramed Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP