This is an open-label, single treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
2,858
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). 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-102 or \> 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.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). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Time frame: thirteen 28-day cycles
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). 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-102 or \> 7 days after stopping the combination DSG/EE or EE treatment of DR-102.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). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Time frame: thirteen 28-day cycles
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). 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-102 or \> 7 days after stopping the combination DSG/EE or EE treatment of DR-102.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). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
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Teva Investigational Site 10007
Montgomery, Alabama, United States
Teva Investigational Site 10013
Phoenix, Arizona, United States
Teva Investigational Site 10017
Phoenix, Arizona, United States
Teva Investigational Site 10032
Little Rock, Arkansas, United States
Teva Investigational Site 10026
San Diego, California, United States
Teva Investigational Site 10056
San Diego, California, United States
Teva Investigational Site 10002
Colorado Springs, Colorado, United States
Teva Investigational Site 10033
Colorado Springs, Colorado, United States
Teva Investigational Site 10057
Washington D.C., District of Columbia, United States
Teva Investigational Site 10052
Clearwater, Florida, United States
...and 52 more locations
Time frame: thirteen 28-day cycles
All Users Life-Table Estimates of Pregnancy Rates Based on 28-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 thirteen 28-day treatment cycles.
Time frame: thirteen 28-day cycles
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-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 thirteen 28-day treatment cycles. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
Time frame: thirteen 28-day cycles
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Time frame: thirteen 28-day cycles
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Time frame: thirteen 28-day cycles
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
Time frame: thirteen 28-day cycles
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m\^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Time frame: thirteen 28-day cycles
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m\^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Time frame: thirteen 28-day cycles
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m\^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
Time frame: thirteen 28-day cycles