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

PHASE3CompletedINTERVENTIONAL
Enrollment

2,235

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

June 30, 2007

Study Completion Date

June 30, 2007

Conditions
Contraception
Interventions
DRUG

DR-1011

Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).

Trial Locations (55)

14609

Duramed Investigational Site, Rochester

15206

Duramed Investigational Site, Pittsburgh

15213

Duramed Investigational Site, Pittsburgh

19090

Duramed Investigational Site, Willow Grove

19114

Duramed Investigational Site, Philadelphia

23226

Duramed Investigational Site, Richmond

23507

Duramed Investigational Site, Norfolk

23602

Duramed Investigational Site, Newport News

27103

Duramed Investigational Site, Winston-Salem

28222

Duramed Investigational Site, Charlotte

28412

Duramed Investigational Site, Wilmington

30034

Duramed Investigational Site, Decatur

30134

Duramed Investigational Site, Douglasville

32216

Duramed Investigational Site, Jacksonville

33024

Duramed Investigational Site, Hollywood

33134

Duramed Investigational Site, Coral Cables

33143

Duramed Investigational Site, Miami

33437

Duramed Investigational Site, Palm Springs

33607

Duramed Investigational Site, Tampa

34239

Duramed Investigational Site, Sarasota

34748

Duramed Investigational Site, Leesburg

35801

Duramed Investigational Site, Huntsville

40291

Duramed Investigational Site, Louisville

43205

Duramed Investigational Site, Columbus

43213

Duramed Investigational Site, Columbus

60611

Duramed Investigational Site, Chicago

63110

Duramed Investigational Site, St Louis

64106

Duramed Investigational Site, Kansas City

66216

Duramed Investigational Site, Shawnee Mission

66614

Duramed Investigational Site, Topeka

73112

Duramed Investigational Site, Oklahoma City

75390

Duramed Investigational Site, Dallas

76712

Duramed Investigational Site, Waco

77030

Duramed Investigational Site, Houston

78229

Duramed Investigational Site, San Antonio

80202

Duramed Investigational Site, Denver

80907

Duramed Investigational Site, Colorado Springs

80909

Duramed Investigational Site, Colorado Springs

83704

Duramed Investigational Site, Boise

84124

Duramed Investigational Site, Salt Lake City

85013

Duramed Investigational Site, Phoenix

85031

Duramed Investigational Site, Phoenix

85032

Duramed Investigational Site, Phoenix

85712

Duramed Investigational Site, Tucson

92103

Duramed Investigational Site, San Diego

92108

Duramed Investigational Site, San Diego

97504

Duramed Investigational Site, Medford

98105

Duramed Investigational Site, Seattle

98405

Duramed Investigational Site, Tacoma

98499

Duramed Investigational Site, Lakewood

99207

Duramed Investigational Site, Spokane

06320

Duramed Investigational Site, New London

08648

Duramed Investigational Site, Lawrenceville

08057

Duramed Investigational Site, Moorestown

08901

Duramed Investigational Site, New Brunswick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duramed Research

INDUSTRY