Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive - Full Text View

Sponsor:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00196326

Purpose

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Condition	Intervention	Phase
Contraception	Drug: DR-1011	Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:

Pregnancy Rate (Pearl Index) [ Time Frame: After the onset of treatment and within 14 days after the last combination pill (approx. 1 year of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events Reported by Patients and Investigators [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]

Enrollment:	2235
Study Start Date:	June 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Investigational Drug	Drug: DR-1011 1 tablet daily

Eligibility

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

Criteria

Inclusion Criteria:

Premenopausal
Not pregnant or breastfeeding
Sexually active at risk of pregnancy

Exclusion Criteria:

Any contraindication to the use of oral contraceptives
Pregnancy within the last 3 months
Smoking > 10 cigarettes per day

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196326

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Locations

United States, Alabama
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Duramed Investigational Site
Phoenix, Arizona, United States, 85031
Duramed Investigational Site
Tucson, Arizona, United States, 85712
Duramed Investigational Site
Phoenix, Arizona, United States, 85013
Duramed Investigational Site
Phoenix, Arizona, United States, 85032
United States, California
Duramed Investigational Site
San Diego, California, United States, 92103
Duramed Investigational Site
San Diego, California, United States, 92108
United States, Colorado
Duramed Investigational Site
Colorado Springs, Colorado, United States, 80909
Duramed Investigational Site
Colorado Springs, Colorado, United States, 80907
Duramed Investigational Site
Denver, Colorado, United States, 80202
United States, Connecticut
Duramed Investigational Site
New London, Connecticut, United States, 06320
United States, Florida
Duramed Investigational Site
Palm Springs, Florida, United States, 33437
Duramed Investigational Site
Miami, Florida, United States, 33143
Duramed Investigational Site
Hollywood, Florida, United States, 33024
Duramed Investigational Site
Jacksonville, Florida, United States, 32216
Duramed Investigational Site
Leesburg, Florida, United States, 34748
Duramed Investigational Site
Coral Cables, Florida, United States, 33134
Duramed Investigational Site
Sarasota, Florida, United States, 34239
Duramed Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Duramed Investigational Site
Douglasville, Georgia, United States, 30134
Duramed Investigational Site
Decatur, Georgia, United States, 30034
United States, Idaho
Duramed Investigational Site
Boise, Idaho, United States, 83704
United States, Illinois
Duramed Investigational Site
Chicago, Illinois, United States, 60611
United States, Kansas
Duramed Investigational Site
Shawnee Mission, Kansas, United States, 66216
Duramed Investigational Site
Topeka, Kansas, United States, 66614
United States, Kentucky
Duramed Investigational Site
Louisville, Kentucky, United States, 40291
United States, Missouri
Duramed Investigational Site
St. Louis, Missouri, United States, 63110
Duramed Investigational Site
Kansas City, Missouri, United States, 64106
United States, New Jersey
Duramed Investigational Site
New Brunswick, New Jersey, United States, 08901
Duramed Investigational Site
Lawrenceville, New Jersey, United States, 08648
Duramed Investigational Site
Moorestown, New Jersey, United States, 08057
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, 28222
Duramed Investigational Site
Wilmington, North Carolina, United States, 28412
Duramed Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Duramed Investigational Site
Columbus, Ohio, United States, 43205
Duramed Investigational Site
Columbus, Ohio, United States, 43213
United States, Oklahoma
Duramed Investigational Site
Oklahoma, Oklahoma, United States, 73112
United States, Oregon
Duramed Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Duramed Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
Duramed Investigational Site
Willow Grove, Pennsylvania, United States, 19090
Duramed Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Duramed Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Duramed Investigational Site
Dallas, Texas, United States, 75390
Duramed Investigational Site
San Antonio, Texas, United States, 78229
Duramed Investigational Site
Waco, Texas, United States, 76712
Duramed Investigational Site
Houston, Texas, United States, 77030
United States, Utah
Duramed Investigational Site
Salt Lake City, Utah, United States, 84124
United States, Virginia
Duramed Investigational Site
Norfolk, Virginia, United States, 23507
Duramed Investigational Site
Newport News, Virginia, United States, 23602
Duramed Investigational Site
Richmond, Virginia, United States, 23226
United States, Washington
Duramed Investigational Site
Seattle, Washington, United States, 98105
Duramed Investigational Site
Tacoma, Washington, United States, 98405
Duramed Investigational Site
Lakewood, Washington, United States, 98499
Duramed Investigational Site
Spokane, Washington, United States, 99207

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

More Information

No publications provided

Responsible Party:	Duramed Research, Inc. ( Druamed Protocol Chair )
Study ID Numbers:	DR-PSE-309
Study First Received:	September 12, 2005
Results First Received:	November 21, 2008
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00196326 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

pregnancy prevention
oral contraceptives

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists

Contraceptive Agents, Female
Ethinyl Estradiol
Reproductive Control Agents
Hormones
Pharmacologic Actions
Estradiol

ClinicalTrials.gov processed this record on November 27, 2009