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

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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

September 12, 2005
September 20, 2005
April 8, 2014
May 2003
November 2006   (Final data collection date for primary outcome measure)
Patient and Investigator reports of adverse events [ Time Frame: Duration of Study ]
Patient and Investigator reports of adverse events
Complete list of historical versions of study NCT00196352 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
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.
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.
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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Contraception
Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
1 tablet daily
Other Name: Seasonique
Experimental: 1
Intervention: Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
400
November 2006
November 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00196352
PSE-304
No
Not Provided
Not Provided
Duramed Protocol Chair, Duramed Research, Inc.
Duramed Research
Not Provided
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
Teva Pharmaceutical Industries
April 2014

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