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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

Page last updated: August 23, 2015

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