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...
Date First Received: September 12, 2005
Last Updated: February 29, 2008
Verified by: Duramed Research, February 2008
Clinical Trial Phase: Phase 3 | Start Date: May 2003
Overall Status: Completed
Estimated Enrollment: 320
Brief Summary
Official Title: “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.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Study Primary Completion Date: November 2006
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
- 1 tablet daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- Patient and Investigator reports of adverse events
- Time Frame: Duration of Study
Safety Issue?: Yes
- Time Frame: Duration of Study
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Participant in the earlier Phase 3 Seasonique clinical trial
Exclusion Criteria:
- Any contraindication to the use of oral contraceptives
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Duramed Research
Overall Clinical Trial Officials and Contacts
Duramed Protocol Chair Study Chair Duramed Research, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00196352
Study ID Number: PSE-304
ClinicalTrials.gov Identifier: NCT00196352
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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