Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: DR-1021

Detailed Description

The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

• Study Type: Interventional
• Enrollment (Actual): 1347
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Duramed Investigational Site
    • Mobile, Alabama, United States, 36608
      • Duramed Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Duramed Investigational Site
    • Phoenix, Arizona, United States, 85031
      • Duramed Investigational Site
  • California
    • Carmichael, California, United States, 95608
      • Duramed Investigational Site
    • Irvine, California, United States, 92618
      • Duramed Investigational Site
    • San Diego, California, United States, 92108
      • Duramed Investigational Site
    • San Diego, California, United States, 92123
      • Duramed Investigational Site
    • San Ramon, California, United States, 94583
      • Duramed Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Duramed Investigational Site
    • Lakewood, Colorado, United States, 80228
      • Duramed Investigational Site
  • Delaware
    • Wilmington, Delaware, United States, 19805
      • Duramed Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • Duramed Investigational Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Duramed Investigational Site
    • Boynton Beach, Florida, United States, 33437
      • Duramed Investigational Site
    • Brooksville, Florida, United States, 33613
      • Duramed Investigational Site
    • Clearwater, Florida, United States, 33761
      • Duramed Investigational Site
    • Coral Gables, Florida, United States, 33134
      • Duramed Investigational Site
    • Fort Meyers, Florida, United States, 33918
      • Duramed Investigational Site
    • Leesburg, Florida, United States, 34748
      • Duramed Investigational Site
    • Longwood, Florida, United States, 32779
      • Duramed Investigational Site
    • Miami, Florida, United States, 33173
      • Duramed Investigational Site
    • Pinellas Park, Florida, United States, 33781
      • Duramed Investigational Site
    • Sarasota, Florida, United States, 34239
      • Duramed Investigational Site
    • St. Petersburg, Florida, United States, 33702
      • Duramed Investigational Site
    • St. Petersburg, Florida, United States, 33709
      • Duramed Investigational Site
    • Tampa, Florida, United States, 33613
      • Duramed Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • Duramed Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Duramed Investigational Site
    • Atlanta, Georgia, United States, 30328
      • Duramed Investigational Site
    • Decatur, Georgia, United States, 30034
      • Duramed Investigational Site
    • Roswell, Georgia, United States, 30075
      • Duramed Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83704
      • Duramed Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Duramed Investigational Site
    • Chicago, Illinois, United States, 60612
      • Duramed Investigational Site
    • Peoria, Illinois, United States, 61602
      • Duramed Investigational Site
  • Kansas
    • Shawnee Mission, Kansas, United States, 66216
      • Duramed Investigational Site
    • Topeka, Kansas, United States, 66614
      • Duramed Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Duramed Investigational Site
    • Louisville, Kentucky, United States, 40291
      • Duramed Investigational Site
    • Mt Sterling, Kentucky, United States, 40353
      • Duramed Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Duramed Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Duramed Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Duramed Investigational Site
  • New Jersey
    • Moorestown, New Jersey, United States, 08057
      • Duramed Investigational Site
    • New Brunswick, New Jersey, United States, 08901
      • Duramed Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Duramed Investigational Site
  • New York
    • Johnson City, New York, United States, 13790
      • Duramed Investigational Site
    • Rochester, New York, United States, 14609
      • Duramed Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Duramed Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • Duramed Investigational Site
    • Wilmington, North Carolina, United States, 28412
      • Duramed Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Duramed Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Duramed Investigational Site
    • Columbus, Ohio, United States, 43213
      • Duramed Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Duramed Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Duramed Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Duramed Investigational Site
    • Reading, Pennsylvania, United States, 19606
      • Duramed Investigational Site
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Duramed Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Duramed Investigational Site
    • Mt Pleasant, South Carolina, United States, 29464
      • Duramed Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Duramed Investigational Site
    • Chattanooga, Tennessee, United States, 37404
      • Duramed Investigational Site
    • Clarksville, Tennessee, United States, 37043
      • Duramed Investigational Site
    • Germantown, Tennessee, United States, 38138
      • Duramed Investigational Site
    • Knoxville, Tennessee, United States, 37920
      • Duramed Investigational Site
    • Nashville, Tennessee, United States, 37203
      • Duramed Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Duramed Investigational Site
    • Dallas, Texas, United States, 75234
      • Duramed Investigational Site
    • Houston, Texas, United States, 77030
      • Duramed Investigational Site
    • San Antonio, Texas, United States, 78229
      • Duramed Investigational Site
    • Waco, Texas, United States, 76712
      • Duramed Investigational Site
  • Utah
    • Magna, Utah, United States, 84044
      • Duramed Investigational Site
    • Pleasant Grove, Utah, United States, 84062
      • Duramed Investigational Site
    • Salt Lake City, Utah, United States, 84124
      • Duramed Investigational Site
    • Sandy, Utah, United States, 84070
      • Duramed Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22203
      • Duramed Investigational Site
    • Newport News, Virginia, United States, 23602
      • Duramed Investigational Site
    • Norfolk, Virginia, United States, 23507
      • Duramed Investigational Site
    • Richmond, Virginia, United States, 23233
      • Duramed Investigational Site
  • Washington
    • Lakewood, Washington, United States, 98499
      • Duramed Investigational Site
    • Seattle, Washington, United States, 98105
      • Duramed Investigational Site
    • Spokane, Washington, United States, 99207
      • Duramed Investigational Site
    • Tacoma, Washington, United States, 98405
      • Duramed Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: DR-1021; 1 tablet daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of pregnancy rates	Duration of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events reported by patients and investigators	Duration of study

Collaborators and Investigators

• Sponsor: Duramed Research
• Investigators: Principal Investigator: Duramed Medical Monitor, Duramed Research

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: August 9, 2006
• First Submitted That Met QC Criteria: August 9, 2006
• First Posted (Estimate): August 10, 2006

Study Record Updates

• Last Update Posted (Estimate): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: oral contraceptives; pregnancy prevention
• Other Study ID Numbers: DR-DSG-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No