A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
- Conditions
- Female ContraceptionContraception
- Interventions
- Drug: DR-102
- Registration Number
- NCT01178125
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2858
- Sexually active at risk for pregnancy
- Agreement to use study oral contraceptive 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 protocol
- Any contraindication to the use of oral contraceptives
- Pregnancy or plans to become pregnant in the next 14 months
- Smoker and age greater than or equal to 35 years
- Others as dictated by protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DR-102 DR-102 desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
- Primary Outcome Measures
Name Time Method 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 thirteen 28-day cycles 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.
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 thirteen 28-day cycles 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 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 thirteen 28-day cycles 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.
- Secondary Outcome Measures
Name Time Method All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight thirteen 28-day cycles 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 Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight thirteen 28-day cycles 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.
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule thirteen 28-day cycles 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.
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule thirteen 28-day cycles 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.
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule thirteen 28-day cycles 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.
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule thirteen 28-day cycles 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.
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule thirteen 28-day cycles 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.
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule thirteen 28-day cycles 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.
Trial Locations
- Locations (62)
Teva Investigational Site 80102
🇮🇱Tel-Aviv, Israel
Teva Investigational Site 80101
🇮🇱Modi'in, Israel
Teva Investigational Site 80106
🇮🇱Tel-Aviv, Israel
Teva Investigational Site 80107
🇮🇱Haifa, Israel
Teva Investigational Site 80103
🇮🇱Or-Yehuda, Israel
Teva Investigational Site 80100
🇮🇱Petach-Tikva, Israel
Teva Investigational Site 80105
🇮🇱RishonLe'zio, Israel
Teva Investigational Site 80109
🇮🇱Givataim, Israel
Teva Investigational Site 10003
🇺🇸Pittsburgh, Pennsylvania, United States
Teva Investigational Site 10040
🇺🇸Charlotte, North Carolina, United States
Teva Investigational Site 10028
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 10037
🇺🇸Columbia, South Carolina, United States
Teva Investigational Site 10047
🇺🇸Mount Pleasant, South Carolina, United States
Teva Investigational Site 10007
🇺🇸Montgomery, Alabama, United States
Teva Investigational Site 10013
🇺🇸Phoenix, Arizona, United States
Teva Investigational Site 10043
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 10017
🇺🇸Phoenix, Arizona, United States
Teva Investigational Site 10056
🇺🇸San Diego, California, United States
Teva Investigational Site 10026
🇺🇸San Diego, California, United States
Teva Investigational Site 10002
🇺🇸Colorado Springs, Colorado, United States
Teva Investigational Site 10052
🇺🇸Clearwater, Florida, United States
Teva Investigational Site 10057
🇺🇸Washington, District of Columbia, United States
Teva Investigational Site 10033
🇺🇸Colorado Springs, Colorado, United States
Teva Investigational Site 10036
🇺🇸Leesburg, Florida, United States
Teva Investigational Site 10015
🇺🇸Miami, Florida, United States
Teva Investigational Site 10055
🇺🇸Palm Beach Gardens, Florida, United States
Teva Investigational Site 10001
🇺🇸West Palm Beach, Florida, United States
Teva Investigational Site 10031
🇺🇸Decatur, Georgia, United States
Teva Investigational Site 10041
🇺🇸Roswell, Georgia, United States
Teva Investigational Site 10050
🇺🇸Savannah, Georgia, United States
Teva Investigational Site 10008
🇺🇸Louisville, Kentucky, United States
Teva Investigational Site 10023
🇺🇸Mount Sterling, Kentucky, United States
Teva Investigational Site 10048
🇺🇸Lawrenceville, New Jersey, United States
Teva Investigational Site 10030
🇺🇸Moorestown, New Jersey, United States
Teva Investigational Site 10014
🇺🇸Albuquerque, New Mexico, United States
Teva Investigational Site 10006
🇺🇸Rochester, New York, United States
Teva Investigational Site 10049
🇺🇸Bluffton, South Carolina, United States
Teva Investigational Site 10044
🇺🇸Cary, North Carolina, United States
Teva Investigational Site 10034
🇺🇸New Bern, North Carolina, United States
Teva Investigational Site 10018
🇺🇸Winston-Salem, North Carolina, United States
Teva Investigational Site 10046
🇺🇸Winston-Salem, North Carolina, United States
Teva Investigational Site 10022
🇺🇸Columbus, Ohio, United States
Teva Investigational Site 10039
🇺🇸Columbus, Ohio, United States
Teva Investigational Site 10016
🇺🇸Jackson, Tennessee, United States
Teva Investigational Site 10005
🇺🇸Memphis, Tennessee, United States
Teva Investigational Site 10042
🇺🇸Nashville, Tennessee, United States
Teva Investigational Site 10054
🇺🇸Dallas, Texas, United States
Teva Investigational Site 10019
🇺🇸Houston, Texas, United States
Teva Investigational Site 10020
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 10038
🇺🇸Arlington, Virginia, United States
Teva Investigational Site 10024
🇺🇸Norfolk, Virginia, United States
Teva Investigational Site 10051
🇺🇸Norfolk, Virginia, United States
Teva Investigational Site 10053
🇺🇸Richmond, Virginia, United States
Teva Investigational Site 10027
🇺🇸Seattle, Washington, United States
Teva Investigational Site 10029
🇺🇸Tacoma, Washington, United States
Teva Investigational Site 80108
🇮🇱Beer Sheva, Israel
Teva Investigational Site 80104
🇮🇱Haifa, Israel
Teva Investigational Site 10021
🇺🇸Jacksonville, Florida, United States
Teva Investigational Site 10012
🇺🇸Miami, Florida, United States
Teva Investigational Site 10035
🇺🇸Greenville, South Carolina, United States
Teva Investigational Site 10045
🇺🇸Knoxville, Tennessee, United States
Teva Investigational Site 10032
🇺🇸Little Rock, Arkansas, United States