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

Pregnancy Prevention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996580
• Other study ID #: DR-103-301
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2009
• Last updated: June 13, 2013
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3597
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pregnancy Prevention

Intervention

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.

Locations

Country	Name	City	State
United States	Teva Women's Health Research Investigational Site	Albuquerque	New Mexico
United States	Teva Women's Health Research Investigational Site	Anaheim	California
United States	Teva Women's Health Research Investigational Site	Arlington	Virginia
United States	Teva Women's Health Research Investigational Site	Atlanta	Georgia
United States	Teva Women's Health Research Investigational Site	Austin	Texas
United States	Teva Women's Health Research Investigational Site	Baltimore	Maryland
United States	Teva Women's Health Research Investigational Site	Baton Rouge	Louisiana
United States	Teva Women's Health Research Investigational Site	Berlin	New Jersey
United States	Teva Women's Health Research Investigational Site	Bristol	Tennessee
United States	Teva Women's Health Research Investigational Site	Cary	North Carolina
United States	Teva Women's Health Research Investigational Site	Champaign	Illinois
United States	Teva Women's Health Research Investigational Site	Charleston	South Carolina
United States	Teva Women's Health Research Investigational Site	Charlotte	North Carolina
United States	Teva Women's Health Research Investigational Site	Clearwater	Florida
United States	Teva Women's Health Research Investigational Site	Colorado Springs	Colorado
United States	Teva Women's Health Research Investigational Site	Columbia	South Carolina
United States	Teva Women's Health Research Investigational Site	Columbus	Ohio
United States	Teva Women's Health Research Investigational Site	Columbus	Ohio
United States	Teva Women's Health Research Investigational Site	Dallas	Texas
United States	Teva Women's Health Research Investigational Site	Dallas	Texas
United States	Teva Women's Health Research Investigational Site	Decatur	Georgia
United States	Teva Women's Health Research Investigational Site	Edmond	Oklahoma
United States	Teva Women's Health Research Investigational Site	Eugene	Oregon
United States	Teva Women's Health Research Investigational Site	Ft. Worth	Texas
United States	Teva Women's Health Research Investigational Site	Goose Creek	South Carolina
United States	Teva Women's Health Research Investigational Site	Greenville	South Carolina
United States	Teva Women's Health Research Investigational Site	Greer	South Carolina
United States	Teva Women's Health Research Investigational Site	Hilton Head Island	South Carolina
United States	Teva Women's Health Research Investigational Site	Houston	Texas
United States	Teva Women's Health Research Investigational Site	Irvine	California
United States	Teva Women's Health Research Investigational Site	Jackson	Tennessee
United States	Teva Women's Health Research Investigational Site	Jacksonville	Florida
United States	Teva Women's Health Research Investigational Site	Kansas City	Missouri
United States	Teva Women's Health Research Investigational Site	Knoxville	Tennessee
United States	Teva Women's Health Research Investigational Site	Las Vegas	Nevada
United States	Teva Women's Health Research Investigational Site	Lawrenceville	New Jersey
United States	Teva Women's Health Research Investigational Site	Leesburg	Florida
United States	Teva Women's Health Research Investigational Site	Lexington	Kentucky
United States	Teva Women's Health Research Investigational Site	Lincoln	Nebraska
United States	Teva Women's Health Research Investigational Site	Little Rock	Arkansas
United States	Teva Women's Health Research Investigational Site	Los Angeles	California
United States	Teva Women's Health Research Investigational Site	Louisville	Kentucky
United States	Teva Women's Health Research Investigational Site	Medford	Oregon
United States	Teva Women's Health Research Investigational Site	Memphis	Tennessee
United States	Teva Women's Health Research Investigational Site	Meridian	Idaho
United States	Teva Women's Health Research Investigational Site	Metairie	Louisiana
United States	Teva Women's Health Research Investigational Site	Miami	Florida
United States	Teva Women's Health Research Investigational Site	Miami	Florida
United States	Teva Women's Health Research Investigational Site	Montgomery	Alabama
United States	Teva Women's Health Research Investigational Site	Moorestown	New Jersey
United States	Teva Women's Health Research Investigational Site	Mt Sterling	Kentucky
United States	Teva Women's Health Research Investigational Site	Nashville	Tennessee
United States	Teva Women's Health Research Investigational Site	National City	California
United States	Teva Women's Health Research Investigational Site	New Bern	North Carolina
United States	Teva Women's Health Research Investigational Site	New Brunswick	New Jersey
United States	Teva Women's Health Research Investigational Site	New Port Richey	Florida
United States	Teva Women's Health Research Investigational Site	Newport News	Virginia
United States	Teva Women's Health Research Investigational Site	Norfolk	Virginia
United States	Teva Women's Health Research Investigational Site	Norfolk	Virginia
United States	Teva Women's Health Research Investigational Site	Oklahoma City	Oklahoma
United States	Teva Women's Health Research Investigational Site	Palm Beach	Florida
United States	Teva Women's Health Research Investigational Site	Philadelphia	Pennsylvania
United States	Teva Women's Health Research Investigational Site	Phoenix	Arizona
United States	Teva Women's Health Research Investigational Site	Phoenix	Arizona
United States	Teva Women's Health Research Investigational Site	Pittsburgh	Pennsylvania
United States	Teva Women's Health Research Investigational Site	Port Jefferson	New York
United States	Teva Women's Health Research Investigational Site	Pueblo	Colorado
United States	Teva Women's Health Research Investigational Site	Raleigh	North Carolina
United States	Teva Women's Health Research Investigational Site	Raleigh	North Carolina
United States	Teva Women's Health Research Investigational Site	Richmond	Virginia
United States	Teva Women's Health Research Investigational Site	Rochester	New York
United States	Teva Women's Health Research Investigational Site	Roswell	Georgia
United States	Teva Women's Health Research Investigational Site	Salisbury	North Carolina
United States	Teva Women's Health Research Investigational Site	Salt Lake City	Utah
United States	Teva Women's Health Research Investigational Site	San Antonio	Texas
United States	Teva Women's Health Research Investigational Site	San Diego	California
United States	Teva Women's Health Research Investigational Site	San Diego	California
United States	Teva Women's Health Research Investigational Site	San Diego	California
United States	Teva Women's Health Research Investigational Site	San Francisco	California
United States	Teva Women's Health Research Investigational Site	Sandy Springs	Georgia
United States	Teva Women's Health Research Investigational Site	Savannah	Georgia
United States	Teva Women's Health Research Investigational Site	Seattle	Washington
United States	Teva Women's Health Research Investigational Site	St. Louis	Missouri
United States	Teva Women's Health Research Investigational Site	St. Petersburg	Florida
United States	Teva Women's Health Research Investigational Site	Tacoma	Washington
United States	Teva Women's Health Research Investigational Site	Tampa	Florida
United States	Teva Women's Health Research Investigational Site	Torrance	California
United States	Teva Women's Health Research Investigational Site	Tucson	Arizona
United States	Teva Women's Health Research Investigational Site	Waco	Texas
United States	Teva Women's Health Research Investigational Site	Washington	District of Columbia
United States	Teva Women's Health Research Investigational Site	West Palm Beach	Florida
United States	Teva Women's Health Research Investigational Site	Wichita	Kansas
United States	Teva Women's Health Research Investigational Site	Wilmington	North Carolina
United States	Teva Women's Health Research Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teva Women's Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	Yes
Secondary	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	No
Secondary	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	No