A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Duramed Research Official(s) and/or principal investigator(s): Duramed Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.
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.
Clinical Details
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.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Patient and Investigator reports of adverse events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Participant in the earlier Phase 3 Seasonique clinical trial
Exclusion Criteria:
- Any contraindication to the use of oral contraceptives
Locations and Contacts
Duramed Investigational Site, Tucson, Arizona 85715, United States
Duramed Investigational Site, Washington, District of Columbia 20006, United States
Duramed Investigational Site, Lincoln, Nebraska 68510, United States
Duramed Investigational Site, Rochester, New York 14609, United States
Duramed Investigational Site, Charlotte, North Carolina 28209, United States
Duramed Investigational Site, Winston-Salem, North Carolina 27103, United States
Duramed Investigational Site, Columbus, Ohio 43213, United States
Duramed Investigational Site, Oklahoma City, Oklahoma 73112, United States
Duramed Investigational Site, Nashville, Tennessee 37203, United States
Duramed Investigational Site, Arlington, Virginia 22203, United States
Duramed Investigational Site, Norfolk, Virginia 23507, United States
Additional Information
Starting date: May 2003
Last updated: April 7, 2014
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