Pregnancy Prevention
Conditions
Keywords
Contraception, Oral contraceptives
Brief 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.
Interventions
DRUGDR-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.
Sponsors
Teva Women's Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Participants With Treatment-emergent Adverse Events | Day 1 up to 13 months | 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. |
| Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | Day 1 up to year 1 | 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) |
| Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | Day 1 up to year 1 | 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) |
| All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Day 1 up to year 1 | 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) |
| Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Day 1 up to year 1 | 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) |
| Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Day 1 up to year 1 | 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) |
| All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | Day 1 up to year 1 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Day 1 up to year 1 | 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. |
| All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Day 1 up to year 1 | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 4,962 subjects were screened for participation in this study, and 3,597 took at least one dose of investigational product (Safety population).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3,597 |
| Total | 3,597 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 466 |
| Overall Study | Lost to Follow-up | 480 |
| Overall Study | Noncompliance with the protocol | 137 |
| Overall Study | Other | 29 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Pregnancy | 68 |
| Overall Study | Protocol Violation | 16 |
| Overall Study | Sponsor requested participant withdrawal | 35 |
| Overall Study | Withdrawal by Subject | 217 |
Baseline characteristics
| Characteristic | DR-103 |
|---|---|
| Age Continuous | 27.4 years STANDARD_DEVIATION 7 |
| Body Mass Index | 27.4 kg/m^2 STANDARD_DEVIATION 7 |
| Diastolic Blood Pressure | 72.3 mmHg STANDARD_DEVIATION 8.3 |
| Heart Rate | 74.6 beats/minute STANDARD_DEVIATION 10 |
| Height | 64.6 inches STANDARD_DEVIATION 2.7 |
| Oral Contraceptive Use History Continuous user | 1570 participants |
| Oral Contraceptive Use History New Start | 619 participants |
| Oral Contraceptive Use History Prior User | 1408 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 14 participants |
| Race/Ethnicity, Customized Asian | 78 participants |
| Race/Ethnicity, Customized Black or African American | 696 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 404 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 10 participants |
| Race/Ethnicity, Customized Other | 71 participants |
| Race/Ethnicity, Customized White | 2324 participants |
| Sex: Female, Male Female | 3597 Participants |
| Sex: Female, Male Male | 0 Participants |
| Smoking Status Current Smoker | 602 participants |
| Smoking Status Former Smoker | 636 participants |
| Smoking Status Never Smoked | 2359 participants |
| Systolic Blood Pressure | 113.1 mmHg STANDARD_DEVIATION 10.4 |
| Weight | 162.5 pounds STANDARD_DEVIATION 43.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,567 / 3,597 |
| serious Total, serious adverse events | 58 / 3,597 |
Outcome results
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)
Time frame: Day 1 up to year 1
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 28-day cycle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-103: Total | All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 2.74 pregnancies / 100 woman years exposure |
| DR-103: <90 kg Subpopulation | All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 2.40 pregnancies / 100 woman years exposure |
| DR-103: >=90kg Subpopulation | All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 4.42 pregnancies / 100 woman years exposure |
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)
Time frame: Day 1 up to year 1
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-103: Total | All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 2.82 pregnancies / 100 woman years exposure |
| DR-103: <90 kg Subpopulation | All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 2.46 pregnancies / 100 woman years exposure |
| DR-103: >=90kg Subpopulation | All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 4.54 pregnancies / 100 woman years exposure |
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)
Time frame: Day 1 up to year 1
Population: 'Compliant-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-103: Total | Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 3.07 pregnancies / 100 woman years exposure |
| DR-103: <90 kg Subpopulation | Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 2.68 pregnancies / 100 woman years exposure |
| DR-103: >=90kg Subpopulation | Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 4.94 pregnancies / 100 woman years exposure |
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)
Time frame: Day 1 up to year 1
Population: 'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-103: Total | Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 3.71 pregnancies / 100 woman years exposure |
| DR-103: <90 kg Subpopulation | Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 3.23 pregnancies / 100 woman years exposure |
| DR-103: >=90kg Subpopulation | Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 6.04 pregnancies / 100 woman years exposure |
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.
Time frame: Day 1 up to 13 months
Population: Safety population of treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-103: Total | Summary of Participants With Treatment-emergent Adverse Events | Treatment-emergent AEs (TEAEs) | 2605 participants |
| DR-103: Total | Summary of Participants With Treatment-emergent Adverse Events | Treatment-related AEs | 1086 participants |
| DR-103: Total | Summary of Participants With Treatment-emergent Adverse Events | Serious AEs | 58 participants |
| DR-103: Total | Summary of Participants With Treatment-emergent Adverse Events | TEAEs leading to discontinuation | 463 participants |
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)
Time frame: Day 1 up to year 1
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods including condoms were used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-103: Total | Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 2.92 pregnancies / 100 woman years exposure |
| DR-103: <90 kg Subpopulation | Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 2.55 pregnancies / 100 woman years exposure |
| DR-103: >=90kg Subpopulation | Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight | 4.72 pregnancies / 100 woman years exposure |
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)
Time frame: Day 1 up to year 1
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods including condoms were used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-103: Total | Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 3.25 pregnancies / 100 woman years exposure |
| DR-103: <90 kg Subpopulation | Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 2.83 pregnancies / 100 woman years exposure |
| DR-103: >=90kg Subpopulation | Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | 5.32 pregnancies / 100 woman years exposure |
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.
Time frame: Day 1 up to year 1
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-103: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0212 pregnancies / cumulative exposure |
| DR-103: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0.0074 pregnancies / cumulative exposure |
| DR-103: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0272 pregnancies / cumulative exposure |
| DR-103: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0134 pregnancies / cumulative exposure |
| DR-103: <90 kg Subpopulation | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0185 pregnancies / cumulative exposure |
| DR-103: <90 kg Subpopulation | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0114 pregnancies / cumulative exposure |
| DR-103: <90 kg Subpopulation | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0.0060 pregnancies / cumulative exposure |
| DR-103: <90 kg Subpopulation | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0239 pregnancies / cumulative exposure |
| DR-103: >=90kg Subpopulation | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0231 pregnancies / cumulative exposure |
| DR-103: >=90kg Subpopulation | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0.0139 pregnancies / cumulative exposure |
| DR-103: >=90kg Subpopulation | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0429 pregnancies / cumulative exposure |
| DR-103: >=90kg Subpopulation | All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0339 pregnancies / cumulative exposure |
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.
Time frame: Day 1 up to year 1
Population: 'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-103: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0.0080 pregnancies / cumulative exposure |
| DR-103: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0134 pregnancies / cumulative exposure |
| DR-103: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0236 pregnancies / cumulative exposure |
| DR-103: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0291 pregnancies / cumulative exposure |
| DR-103: <90 kg Subpopulation | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0256 pregnancies / cumulative exposure |
| DR-103: <90 kg Subpopulation | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0.0062 pregnancies / cumulative exposure |
| DR-103: <90 kg Subpopulation | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0203 pregnancies / cumulative exposure |
| DR-103: <90 kg Subpopulation | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0116 pregnancies / cumulative exposure |
| DR-103: >=90kg Subpopulation | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0457 pregnancies / cumulative exposure |
| DR-103: >=90kg Subpopulation | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0215 pregnancies / cumulative exposure |
| DR-103: >=90kg Subpopulation | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0392 pregnancies / cumulative exposure |
| DR-103: >=90kg Subpopulation | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0.0164 pregnancies / cumulative exposure |