Contraception, Female Contraception
Conditions
Keywords
Pregnancy Prevention, Oral Contraceptives
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.
Interventions
DRUGDR-102
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
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 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year. | AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event. |
| Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal) | A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris. |
Countries
Israel, United States
Participant flow
Recruitment details
A total of 3691 women desiring pregnancy prevention were screened for enrollment into this study. Of the 3691 subjects screened, 2858 subjects at 53 centers in the US and 9 centers in Israel met entry criteria and were considered to be eligible for enrollment into the study.
Pre-assignment details
Of the 2858 enrolled, 93 participants withdrew from study before taking any investigational product, for the following reasons: lost to follow-up (n=34), consent withdrawn (n=17), sponsor request (n=13), withdrawn due to pregnancy (n=11), noncompliance (n=6), other (n=6), protocol violation (n=3), adverse event(n=2), investigator request (n=2).
Participants by arm
| Arm | Count |
|---|---|
| DR-102 desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days | 2,765 |
| Total | 2,765 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 244 |
| Overall Study | Investigator Decision | 5 |
| Overall Study | Lost to Follow-up | 397 |
| Overall Study | Noncompliance | 184 |
| Overall Study | Other Reason | 39 |
| Overall Study | Pregnancy | 55 |
| Overall Study | Protocol Violation | 17 |
| Overall Study | Sponsor Decision | 28 |
| Overall Study | Withdrawal by Subject | 209 |
Baseline characteristics
| Characteristic | DR-102 |
|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 5.44 |
| Body Mass Index (BMI) | 26.9 kg/m^2 STANDARD_DEVIATION 6.54 |
| Race/Ethnicity, Customized Asian | 72 participants |
| Race/Ethnicity, Customized Black | 428 participants |
| Race/Ethnicity, Customized Hispanic | 393 participants |
| Race/Ethnicity, Customized Other | 74 participants |
| Race/Ethnicity, Customized White | 1798 participants |
| Sex: Female, Male Female | 2765 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 72.4 kg STANDARD_DEVIATION 18.62 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,319 / 2,765 |
| serious Total, serious adverse events | 46 / 2,765 |
Outcome results
Primary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-102: Total | 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 | 2.43 pregnancies / 100 woman years exposure |
| DR-102: Baseline Body Weight <90 kg | 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 | 2.35 pregnancies / 100 woman years exposure |
| DR-102: Baseline Body Weight ≥90 kg | 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 | 2.90 pregnancies / 100 woman years exposure |
Primary
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.
Time frame: thirteen 28-day cycles
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used, and who were deemed to be compliant, per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-102: Total | 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 | 2.00 pregnancies / 100 woman years exposure |
| DR-102: Baseline Body Weight <90 kg | 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 | 1.79 pregnancies / 100 woman years exposure |
| DR-102: Baseline Body Weight ≥90 kg | 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 | 3.25 pregnancies / 100 woman years exposure |
Primary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-102: Total | 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 | 2.68 pregnancies / 100 woman years exposure |
| DR-102: Baseline Body Weight <90 kg | 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 | 2.59 pregnancies / 100 woman years exposure |
| DR-102: Baseline Body Weight ≥90 kg | 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 | 3.23 pregnancies / 100 woman years exposure |
Secondary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 9 | 0.0161 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0031 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 5 | 0.0078 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 12 | 0.0209 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0.0004 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 6 | 0.0088 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 10 | 0.0184 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 13 | 0.0247 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 7 | 0.0104 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 11 | 0.0190 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0073 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 8 | 0.0132 pregnancies / cumulative exposure |
| DR-102: Total | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0013 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 8 | 0.0120 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 9 | 0.0153 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 10 | 0.0174 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 11 | 0.0181 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0031 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 13 | 0.0240 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0070 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 12 | 0.0195 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 5 | 0.0070 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 6 | 0.0082 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0.0005 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 7 | 0.0094 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0010 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 13 | 0.0287 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 9 | 0.0202 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0028 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0028 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0091 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 5 | 0.0125 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 6 | 0.0125 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 7 | 0.0163 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 8 | 0.0202 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 10 | 0.0243 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 11 | 0.0243 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 12 | 0.0287 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0 pregnancies / cumulative exposure |
Secondary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other BCMs, including condoms, were used, and who were deemed to be compliant, per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 12 | 0.0174 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 9 | 0.0152 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 6 | 0.0063 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0038 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 8 | 0.0102 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 7 | 0.0072 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0015 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 11 | 0.0163 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0063 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 13 | 0.0208 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 10 | 0.0163 pregnancies / cumulative exposure |
| DR-102: Total | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 5 | 0.0063 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 7 | 0.0057 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0009 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0037 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0046 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 5 | 0.0046 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 6 | 0.0046 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 8 | 0.0080 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 9 | 0.0139 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 10 | 0.0139 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 11 | 0.0139 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 12 | 0.0152 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight <90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 13 | 0.0191 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 9 | 0.0224 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 4 | 0.0154 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 12 | 0.0298 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 10 | 0.0298 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 3 | 0.0047 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 1 | 0 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 11 | 0.0298 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 7 | 0.0154 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 6 | 0.0154 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 2 | 0.0047 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 8 | 0.0224 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 5 | 0.0154 pregnancies / cumulative exposure |
| DR-102: Baseline Body Weight ≥90 kg | Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight | Cycle 13 | 0.0298 pregnancies / cumulative exposure |
Secondary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in BMI decile group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | ≤20.1 kg/m^2 (n=243) | 1.65 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >20.1 to ≤21.5 kg/m^2 (n=238) | 1.68 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >21.5 to ≤22.7 kg/m^2 (n=240) | 1.67 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >22.7 to ≤23.8 kg/m^2 (n=241) | 0.83 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >23.8 to ≤25.2 kg/m^2 (n=240) | 1.25 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >25.2 to ≤26.6 kg/m^2 (n=242) | 2.07 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >26.6 to ≤28.7 kg/m^2 (n=237) | 2.11 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >28.7 to ≤31.4 kg/m^2 (n=240) | 3.33 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >31.4 to ≤35.6 kg/m^2 (n=241) | 2.49 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >35.6 to ≤68.0 kg/m^2 (n=239) | 2.09 percentage of pregnancies |
Secondary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in the body weight decile group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | ≤53.1 kg (n=249) | 0.40 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >53.1 to ≤57.1 kg (n=248) | 2.42 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >57.1 to ≤60.8 kg (n=249) | 1.61 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >60.8 to ≤64.0 kg (n=234) | 1.28 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >64.0 to ≤67.6 kg (n=222) | 4.05 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >67.6 to ≤72.1 kg (n=249) | 1.20 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >72.1 to ≤77.4 kg (n=230) | 2.17 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >77.4 to ≤85.3 kg (n=251) | 1.99 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >85.3 to ≤97.5 kg (n=236) | 2.12 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule | >97.5 to ≤181.4 kg (n=233) | 2.15 percentage of pregnancies |
Secondary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle and in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in BMI decile group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | ≤20.1 kg/m^2 (n=233) | 0.86 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >20.1 to ≤21.5 kg/m^2 (n=231) | 1.30 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >21.5 to ≤22.7 kg/m^2 (n=239) | 0.84 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >22.7 to ≤23.8 kg/m^2 (n=225) | 0.89 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >23.8 to ≤25.2 kg/m^2 (n=232) | 0.86 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >25.2 to ≤26.6 kg/m^2 (n=233) | 1.29 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >26.6 to ≤28.7 kg/m^2 (n=229) | 2.18 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >28.7 to ≤31.4 kg/m^2 (n=232) | 2.59 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >31.4 to ≤35.7 kg/m^2 (n=233) | 1.72 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >35.7 to ≤68.0 kg/m^2 (n=230) | 2.17 percentage of pregnancies |
Secondary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in body weight decile group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | ≤53.1 kg (n=238) | 0.42 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >53.1 to ≤57.1 kg (n=240) | 1.67 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >57.1 to ≤60.8 kg (n=244) | 1.23 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >60.8 to ≤64.0 kg (n=225) | 0.89 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >64.0 to ≤67.6 kg (n=215) | 2.79 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >67.6 to ≤72.1 kg (n=237) | 0.84 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >72.1 to ≤77.5 kg (n=223) | 2.24 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >77.5 to ≤85.3 kg (n=241) | 0.83 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >85.3 to ≤97.5 kg (n=228) | 1.75 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule | >97.5 to ≤181.4 kg (n=226) | 2.21 percentage of pregnancies |
Secondary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in BMI decile group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >23.8 to ≤25.2 kg/m^2 (n=232) | 1.29 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | ≤20.1 kg/m^2 (n=235) | 1.70 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >20.1 to ≤21.5 kg/m^2 (n=233) | 1.72 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >21.5 to ≤22.7 kg/m^2 (n=232) | 1.72 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >22.7 to ≤23.8 kg/m^2 (n=235) | 0.85 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >25.2 to ≤26.6 kg/m^2 (n=233) | 2.15 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >26.6 to ≤28.7 kg/m^2 (n=234) | 2.14 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >28.7 to ≤31.4 kg/m^2 (n=233) | 3.43 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >31.4 to ≤35.7 kg/m^2 (n=233) | 2.58 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule | >35.7 to ≤68.0 kg/m^2 (n=233) | 2.15 percentage of pregnancies |
Secondary
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
Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in body weight decile group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | ≤53.1 kg (n=240) | 0.42 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >53.1 to ≤57.1 kg (n=240) | 2.50 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >57.1 to ≤60.8 kg (n=245) | 1.63 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >60.8 to ≤64.0 kg (n=227) | 1.32 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >64.0 to ≤67.6 kg (n=217) | 4.15 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >67.6 to ≤72.1 kg (n=240) | 1.25 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >72.1 to ≤77.5 kg (n=226) | 2.21 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >77.5 to ≤85.3 kg (n=242) | 2.07 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >85.3 to ≤97.1 kg (n=223) | 2.24 percentage of pregnancies |
| DR-102: Total | Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule | >97.1 to ≤181.4 kg (n=233) | 2.15 percentage of pregnancies |
Other Pre-specified
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris.
Time frame: Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)
Population: Subset of participants with sufficient tissue at both Baseline and Endpoint biopsies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Atrophic | 10 participants |
| DR-102: Total | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Inactive | 13 participants |
| DR-102: Total | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Proliferative | 11 participants |
| DR-102: Total | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Secretory | 38 participants |
| DR-102: Total | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Hyperplasia | 0 participants |
| DR-102: Total | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Menstrual Endometrium | 0 participants |
| DR-102: Baseline Body Weight <90 kg | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Hyperplasia | 0 participants |
| DR-102: Baseline Body Weight <90 kg | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Atrophic | 47 participants |
| DR-102: Baseline Body Weight <90 kg | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Secretory | 10 participants |
| DR-102: Baseline Body Weight <90 kg | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Inactive | 6 participants |
| DR-102: Baseline Body Weight <90 kg | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Menstrual Endometrium | 0 participants |
| DR-102: Baseline Body Weight <90 kg | Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint | Proliferative | 9 participants |
Other Pre-specified
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event.
Time frame: Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
Population: Safety population (received at least 1 dose of DR-102)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-102: Total | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Any AE | 1778 participants |
| DR-102: Total | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Severe AEs | 173 participants |
| DR-102: Total | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Treatment-related AEs | 608 participants |
| DR-102: Total | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Deaths | 0 participants |
| DR-102: Total | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Other SAEs | 46 participants |
| DR-102: Total | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Withdrawn From Study Due to AEs | 234 participants |