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A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy Prevention

Intervention: DR-103 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Teva Women's Health

Summary

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Clinical Details

Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight

Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight

Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight

All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight

Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight

Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight

Summary of Participants With Treatment-emergent Adverse Events

Secondary outcome:

All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight

Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Sexually active at risk for pregnancy

- Agreement to use study OC therapy as their only method of birth control during the

study

- history of regular spontaneous menstrual cycles or withdrawal bleeding episodes

- Others as dictated by FDA-approved protocol

Exclusion Criteria:

- Any contraindication to the use of oral contraceptives

- Pregnancy or plans to become pregnant in the next 14 months

- Smoker and age ≥ 35 years

- Others as dictated by FDA-approved protocol

Locations and Contacts

Teva Women's Health Research Investigational Site, Montgomery, Alabama 36116, United States

Teva Women's Health Research Investigational Site, Phoenix, Arizona 85015, United States

Teva Women's Health Research Investigational Site, Phoenix, Arizona 85037, United States

Teva Women's Health Research Investigational Site, Tucson, Arizona 85741, United States

Teva Women's Health Research Investigational Site, Little Rock, Arkansas 72205, United States

Teva Women's Health Research Investigational Site, Anaheim, California 92801, United States

Teva Women's Health Research Investigational Site, Irvine, California 92618, United States

Teva Women's Health Research Investigational Site, Los Angeles, California 90033, United States

Teva Women's Health Research Investigational Site, National City, California 91950, United States

Teva Women's Health Research Investigational Site, San Diego, California 29103, United States

Teva Women's Health Research Investigational Site, San Diego, California 92108, United States

Teva Women's Health Research Investigational Site, San Diego, California 92123, United States

Teva Women's Health Research Investigational Site, San Francisco, California 92103, United States

Teva Women's Health Research Investigational Site, Torrance, California 90502, United States

Teva Women's Health Research Investigational Site, Colorado Springs, Colorado 80909, United States

Teva Women's Health Research Investigational Site, Pueblo, Colorado 81001, United States

Teva Women's Health Research Investigational Site, Washington, District of Columbia 20036, United States

Teva Women's Health Research Investigational Site, Clearwater, Florida 33759, United States

Teva Women's Health Research Investigational Site, Jacksonville, Florida 32207, United States

Teva Women's Health Research Investigational Site, Leesburg, Florida 34748, United States

Teva Women's Health Research Investigational Site, Miami, Florida 33143, United States

Teva Women's Health Research Investigational Site, Miami, Florida 33186, United States

Teva Women's Health Research Investigational Site, New Port Richey, Florida 34652, United States

Teva Women's Health Research Investigational Site, Palm Beach, Florida 33409, United States

Teva Women's Health Research Investigational Site, St. Petersburg, Florida 33709, United States

Teva Women's Health Research Investigational Site, Tampa, Florida 33613, United States

Teva Women's Health Research Investigational Site, West Palm Beach, Florida 33401, United States

Teva Women's Health Research Investigational Site, Atlanta, Georgia 30303, United States

Teva Women's Health Research Investigational Site, Decatur, Georgia 30034, United States

Teva Women's Health Research Investigational Site, Roswell, Georgia 30075, United States

Teva Women's Health Research Investigational Site, Sandy Springs, Georgia 30328, United States

Teva Women's Health Research Investigational Site, Savannah, Georgia 31406, United States

Teva Women's Health Research Investigational Site, Meridian, Idaho 83642, United States

Teva Women's Health Research Investigational Site, Champaign, Illinois 61820, United States

Teva Women's Health Research Investigational Site, Wichita, Kansas 67207, United States

Teva Women's Health Research Investigational Site, Lexington, Kentucky 40509, United States

Teva Women's Health Research Investigational Site, Louisville, Kentucky 40291, United States

Teva Women's Health Research Investigational Site, Mt Sterling, Kentucky 40353, United States

Teva Women's Health Research Investigational Site, Baton Rouge, Louisiana 70808, United States

Teva Women's Health Research Investigational Site, Metairie, Louisiana 70006, United States

Teva Women's Health Research Investigational Site, Baltimore, Maryland 21201, United States

Teva Women's Health Research Investigational Site, Kansas City, Missouri 64108, United States

Teva Women's Health Research Investigational Site, St. Louis, Missouri 63117, United States

Teva Women's Health Research Investigational Site, Lincoln, Nebraska 68510, United States

Teva Women's Health Research Investigational Site, Las Vegas, Nevada 89146, United States

Teva Women's Health Research Investigational Site, Berlin, New Jersey 08009, United States

Teva Women's Health Research Investigational Site, Lawrenceville, New Jersey 08648, United States

Teva Women's Health Research Investigational Site, Moorestown, New Jersey 08057, United States

Teva Women's Health Research Investigational Site, New Brunswick, New Jersey 08901, United States

Teva Women's Health Research Investigational Site, Albuquerque, New Mexico 87102, United States

Teva Women's Health Research Investigational Site, Port Jefferson, New York 11777, United States

Teva Women's Health Research Investigational Site, Rochester, New York 14609, United States

Teva Women's Health Research Investigational Site, Cary, North Carolina 27518, United States

Teva Women's Health Research Investigational Site, Charlotte, North Carolina 28209, United States

Teva Women's Health Research Investigational Site, New Bern, North Carolina 28562, United States

Teva Women's Health Research Investigational Site, Raleigh, North Carolina 27609, United States

Teva Women's Health Research Investigational Site, Raleigh, North Carolina 27612, United States

Teva Women's Health Research Investigational Site, Salisbury, North Carolina 28144, United States

Teva Women's Health Research Investigational Site, Wilmington, North Carolina 28401, United States

Teva Women's Health Research Investigational Site, Winston-Salem, North Carolina 27103, United States

Teva Women's Health Research Investigational Site, Columbus, Ohio 43210, United States

Teva Women's Health Research Investigational Site, Columbus, Ohio 43213, United States

Teva Women's Health Research Investigational Site, Edmond, Oklahoma 73013, United States

Teva Women's Health Research Investigational Site, Oklahoma City, Oklahoma 73112, United States

Teva Women's Health Research Investigational Site, Eugene, Oregon 97401, United States

Teva Women's Health Research Investigational Site, Medford, Oregon 97504, United States

Teva Women's Health Research Investigational Site, Philadelphia, Pennsylvania 19114, United States

Teva Women's Health Research Investigational Site, Pittsburgh, Pennsylvania 15206, United States

Teva Women's Health Research Investigational Site, Charleston, South Carolina 29425, United States

Teva Women's Health Research Investigational Site, Columbia, South Carolina 29201, United States

Teva Women's Health Research Investigational Site, Goose Creek, South Carolina 29445, United States

Teva Women's Health Research Investigational Site, Greenville, South Carolina 29605, United States

Teva Women's Health Research Investigational Site, Greer, South Carolina 29651, United States

Teva Women's Health Research Investigational Site, Hilton Head Island, South Carolina 29926, United States

Teva Women's Health Research Investigational Site, Bristol, Tennessee 37620, United States

Teva Women's Health Research Investigational Site, Jackson, Tennessee 38305, United States

Teva Women's Health Research Investigational Site, Knoxville, Tennessee 37920, United States

Teva Women's Health Research Investigational Site, Memphis, Tennessee 38120, United States

Teva Women's Health Research Investigational Site, Nashville, Tennessee 37203, United States

Teva Women's Health Research Investigational Site, Austin, Texas 78759, United States

Teva Women's Health Research Investigational Site, Dallas, Texas 75234, United States

Teva Women's Health Research Investigational Site, Dallas, Texas 75390, United States

Teva Women's Health Research Investigational Site, Ft. Worth, Texas 76135, United States

Teva Women's Health Research Investigational Site, Houston, Texas 77054, United States

Teva Women's Health Research Investigational Site, San Antonio, Texas 78229, United States

Teva Women's Health Research Investigational Site, Waco, Texas 76712, United States

Teva Women's Health Research Investigational Site, Salt Lake City, Utah 84107, United States

Teva Women's Health Research Investigational Site, Arlington, Virginia 22203, United States

Teva Women's Health Research Investigational Site, Newport News, Virginia 23602, United States

Teva Women's Health Research Investigational Site, Norfolk, Virginia 23502, United States

Teva Women's Health Research Investigational Site, Norfolk, Virginia 23507, United States

Teva Women's Health Research Investigational Site, Richmond, Virginia 23233, United States

Teva Women's Health Research Investigational Site, Seattle, Washington 98105, United States

Teva Women's Health Research Investigational Site, Tacoma, Washington 98405, United States

Additional Information

Starting date: October 2009
Last updated: June 13, 2013

Page last updated: August 23, 2015

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