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

This study has been completed.
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00196352
First received: September 12, 2005
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Contraception
 Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Patient and Investigator reports of adverse events [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]

Enrollment: 320
Study Start Date: May 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
1 tablet daily
Other Name: Seasonique

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196352

Locations
United States, Arizona
Duramed Investigational Site
Tucson, Arizona, United States, 85715
United States, District of Columbia
Duramed Investigational Site
Washington, District of Columbia, United States, 20006
United States, Nebraska
Duramed Investigational Site
Lincoln, Nebraska, United States, 68510
United States, New York
Duramed Investigational Site
Rochester, New York, United States, 14609
United States, North Carolina
Duramed Investigational Site
Charlotte, North Carolina, United States, 28209
Duramed Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Duramed Investigational Site
Columbus, Ohio, United States, 43213
United States, Oklahoma
Duramed Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Tennessee
Duramed Investigational Site
Nashville, Tennessee, United States, 37203
United States, Virginia
Duramed Investigational Site
Arlington, Virginia, United States, 22203
Duramed Investigational Site
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00196352     History of Changes
Other Study ID Numbers: PSE-304
Study First Received: September 12, 2005
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duramed Research:
oral contraceptives
birth control
ethinyl estradiol
pregnancy prevention

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on October 16, 2012