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

April 7, 2014 updated by: Duramed Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Duramed Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Duramed Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Duramed Investigational Site
    • New York
      • Rochester, New York, United States, 14609
        • Duramed Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Duramed Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Duramed Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Duramed Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Duramed Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Duramed Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22203
        • Duramed Investigational Site
      • Norfolk, Virginia, United States, 23507
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
1 tablet daily
Other Names:
  • Seasonique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient and Investigator reports of adverse events
Time Frame: Duration of Study
Duration of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSE-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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