A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive. - Full Text View

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00196352

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 III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate

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
1: Experimental	Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets 1 tablet daily

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
Winston-Salem, North Carolina, United States, 27103
Duramed Investigational Site
Charlotte, North Carolina, United States, 28209
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
Norfolk, Virginia, United States, 23507
Duramed Investigational Site
Arlington, Virginia, United States, 22203

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

More Information

No publications provided

Responsible Party:	Duramed Research, Inc. ( Duramed Protocol Chair )
Study ID Numbers:	PSE-304
Study First Received:	September 12, 2005
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00196352 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

oral contraceptives
birth control
ethinyl estradiol
pregnancy prevention

Study placed in the following topic categories:

Estrogens
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptives, Oral
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists

Ethinyl Estradiol
Estradiol 17 beta-cypionate
Hormones
Estradiol
Estradiol 3-benzoate
Levonorgestrel
Polyestradiol phosphate

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol

Reproductive Control Agents
Hormones
Pharmacologic Actions
Levonorgestrel
Therapeutic Uses
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 03, 2009