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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Prevention
• Intervention / Treatment: Drug: DR-103

• Study Type: Interventional
• Enrollment (Actual): 3597
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36116
      • Teva Women's Health Research Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Teva Women's Health Research Investigational Site
    • Phoenix, Arizona, United States, 85037
      • Teva Women's Health Research Investigational Site
    • Tucson, Arizona, United States, 85741
      • Teva Women's Health Research Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Teva Women's Health Research Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Teva Women's Health Research Investigational Site
    • Irvine, California, United States, 92618
      • Teva Women's Health Research Investigational Site
    • Los Angeles, California, United States, 90033
      • Teva Women's Health Research Investigational Site
    • National City, California, United States, 91950
      • Teva Women's Health Research Investigational Site
    • San Diego, California, United States, 29103
      • Teva Women's Health Research Investigational Site
    • San Diego, California, United States, 92108
      • Teva Women's Health Research Investigational Site
    • San Diego, California, United States, 92123
      • Teva Women's Health Research Investigational Site
    • San Francisco, California, United States, 92103
      • Teva Women's Health Research Investigational Site
    • Torrance, California, United States, 90502
      • Teva Women's Health Research Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Teva Women's Health Research Investigational Site
    • Pueblo, Colorado, United States, 81001
      • Teva Women's Health Research Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Teva Women's Health Research Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33759
      • Teva Women's Health Research Investigational Site
    • Jacksonville, Florida, United States, 32207
      • Teva Women's Health Research Investigational Site
    • Leesburg, Florida, United States, 34748
      • Teva Women's Health Research Investigational Site
    • Miami, Florida, United States, 33143
      • Teva Women's Health Research Investigational Site
    • Miami, Florida, United States, 33186
      • Teva Women's Health Research Investigational Site
    • New Port Richey, Florida, United States, 34652
      • Teva Women's Health Research Investigational Site
    • Palm Beach, Florida, United States, 33409
      • Teva Women's Health Research Investigational Site
    • St. Petersburg, Florida, United States, 33709
      • Teva Women's Health Research Investigational Site
    • Tampa, Florida, United States, 33613
      • Teva Women's Health Research Investigational Site
    • West Palm Beach, Florida, United States, 33401
      • Teva Women's Health Research Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Teva Women's Health Research Investigational Site
    • Decatur, Georgia, United States, 30034
      • Teva Women's Health Research Investigational Site
    • Roswell, Georgia, United States, 30075
      • Teva Women's Health Research Investigational Site
    • Sandy Springs, Georgia, United States, 30328
      • Teva Women's Health Research Investigational Site
    • Savannah, Georgia, United States, 31406
      • Teva Women's Health Research Investigational Site
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Teva Women's Health Research Investigational Site
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Teva Women's Health Research Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Teva Women's Health Research Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Teva Women's Health Research Investigational Site
    • Louisville, Kentucky, United States, 40291
      • Teva Women's Health Research Investigational Site
    • Mt Sterling, Kentucky, United States, 40353
      • Teva Women's Health Research Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Teva Women's Health Research Investigational Site
    • Metairie, Louisiana, United States, 70006
      • Teva Women's Health Research Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Teva Women's Health Research Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Teva Women's Health Research Investigational Site
    • St. Louis, Missouri, United States, 63117
      • Teva Women's Health Research Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Teva Women's Health Research Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Teva Women's Health Research Investigational Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Teva Women's Health Research Investigational Site
    • Lawrenceville, New Jersey, United States, 08648
      • Teva Women's Health Research Investigational Site
    • Moorestown, New Jersey, United States, 08057
      • Teva Women's Health Research Investigational Site
    • New Brunswick, New Jersey, United States, 08901
      • Teva Women's Health Research Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Teva Women's Health Research Investigational Site
  • New York
    • Port Jefferson, New York, United States, 11777
      • Teva Women's Health Research Investigational Site
    • Rochester, New York, United States, 14609
      • Teva Women's Health Research Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Teva Women's Health Research Investigational Site
    • Charlotte, North Carolina, United States, 28209
      • Teva Women's Health Research Investigational Site
    • New Bern, North Carolina, United States, 28562
      • Teva Women's Health Research Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • Teva Women's Health Research Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • Teva Women's Health Research Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • Teva Women's Health Research Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • Teva Women's Health Research Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Teva Women's Health Research Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Teva Women's Health Research Investigational Site
    • Columbus, Ohio, United States, 43213
      • Teva Women's Health Research Investigational Site
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Teva Women's Health Research Investigational Site
    • Oklahoma City, Oklahoma, United States, 73112
      • Teva Women's Health Research Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Teva Women's Health Research Investigational Site
    • Medford, Oregon, United States, 97504
      • Teva Women's Health Research Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Teva Women's Health Research Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15206
      • Teva Women's Health Research Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Teva Women's Health Research Investigational Site
    • Columbia, South Carolina, United States, 29201
      • Teva Women's Health Research Investigational Site
    • Goose Creek, South Carolina, United States, 29445
      • Teva Women's Health Research Investigational Site
    • Greenville, South Carolina, United States, 29605
      • Teva Women's Health Research Investigational Site
    • Greer, South Carolina, United States, 29651
      • Teva Women's Health Research Investigational Site
    • Hilton Head Island, South Carolina, United States, 29926
      • Teva Women's Health Research Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Teva Women's Health Research Investigational Site
    • Jackson, Tennessee, United States, 38305
      • Teva Women's Health Research Investigational Site
    • Knoxville, Tennessee, United States, 37920
      • Teva Women's Health Research Investigational Site
    • Memphis, Tennessee, United States, 38120
      • Teva Women's Health Research Investigational Site
    • Nashville, Tennessee, United States, 37203
      • Teva Women's Health Research Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Teva Women's Health Research Investigational Site
    • Dallas, Texas, United States, 75234
      • Teva Women's Health Research Investigational Site
    • Dallas, Texas, United States, 75390
      • Teva Women's Health Research Investigational Site
    • Ft. Worth, Texas, United States, 76135
      • Teva Women's Health Research Investigational Site
    • Houston, Texas, United States, 77054
      • Teva Women's Health Research Investigational Site
    • San Antonio, Texas, United States, 78229
      • Teva Women's Health Research Investigational Site
    • Waco, Texas, United States, 76712
      • Teva Women's Health Research Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Teva Women's Health Research Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22203
      • Teva Women's Health Research Investigational Site
    • Newport News, Virginia, United States, 23602
      • Teva Women's Health Research Investigational Site
    • Norfolk, Virginia, United States, 23502
      • Teva Women's Health Research Investigational Site
    • Norfolk, Virginia, United States, 23507
      • Teva Women's Health Research Investigational Site
    • Richmond, Virginia, United States, 23233
      • Teva Women's Health Research Investigational Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Teva Women's Health Research Investigational Site
    • Tacoma, Washington, United States, 98405
      • Teva Women's Health Research Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DR-103; Four 91-day cycles of the DR-103 regimen: 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;; 7 days of 10 mcg EE.	Drug: DR-103; One tablet daily. Four 91-day cycles of the DR-103 regimen: 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.; Other Names: levonorgestrel/ethinyl estradiol; Quartette®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)	Day 1 up to year 1
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)	Day 1 up to year 1
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)	Day 1 up to year 1
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)	Day 1 up to year 1
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)	Day 1 up to year 1
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight	Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)	Day 1 up to year 1
Summary of Participants With Treatment-emergent Adverse Events	The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date. Relationship to study drug was assessed by the investigator. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention.	Day 1 up to 13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight	A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.	Day 1 up to year 1
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight	A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.	Day 1 up to year 1

Collaborators and Investigators

• Sponsor: Teva Women's Health

Publications and helpful links

General Publications

• Poindexter A, Reape KZ, Hait H. Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo. Contraception. 2008 Aug;78(2):113-9. doi: 10.1016/j.contraception.2008.04.001. Epub 2008 Jun 2.
• Portman DJ, Kaunitz AM, Howard B, Weiss H, Hsieh J, Ricciotti N. Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive. Contraception. 2014 Apr;89(4):299-306. doi: 10.1016/j.contraception.2014.01.013. Epub 2014 Jan 29.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: October 15, 2009
• First Posted (Estimate): October 16, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 13, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Contraception; Oral contraceptives
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Levonorgestrel; Estradiol; Ethinyl Estradiol
• Other Study ID Numbers: DR-103-301