Contraception
Conditions
Keywords
pregnancy prevention, oral contraceptives
Brief summary
This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. 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-1011
Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
Sponsors
Duramed Research
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
* Premenopausal * Not pregnant or breastfeeding * Sexually active at risk of pregnancy
Exclusion criteria
* Any contraindication to the use of oral contraceptives * Pregnancy within the last 3 months * Smoking \> 10 cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy | up to one year | Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication) |
| Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy | up to one year | Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Treatment-Emergent Adverse Events | Day 1 up to one year | Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values. |
Countries
United States
Participant flow
Pre-assignment details
A total of 2968 subjects were screened and 2235 subjects were enrolled in the study. Of those enrolled, 2185 took at least one dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| DR-1011 Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles. | 2,185 |
| Total | 2,185 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 253 |
| Overall Study | Did not meet protocol requirements | 64 |
| Overall Study | Lost to Follow-up | 304 |
| Overall Study | Non-compliance with the protocol | 81 |
| Overall Study | Other | 22 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Pregnancy | 34 |
| Overall Study | Withdrawal by Subject | 225 |
Baseline characteristics
| Characteristic | DR-1011 |
|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 5.8 |
| Body Mass Index | 26.7 kg/m^2 STANDARD_DEVIATION 6.65 |
| Race/Ethnicity, Customized African-American | 256 participants |
| Race/Ethnicity, Customized Asian | 36 participants |
| Race/Ethnicity, Customized Caucasian | 1627 participants |
| Race/Ethnicity, Customized Hispanic | 218 participants |
| Race/Ethnicity, Customized Other | 48 participants |
| Region of Enrollment United States | 2185 participants |
| Sex: Female, Male Female | 2185 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 158.7 pounds STANDARD_DEVIATION 41.26 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,333 / 2,185 |
| serious Total, serious adverse events | 34 / 2,185 |
Outcome results
Primary
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
Time frame: up to one year
Population: The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-1011 | Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy | Excluding other BCMs (n=1732) | 2.44 pregnancies per 100 woman years exposure |
| DR-1011 | Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy | All complete cycles (n=1735) | 2.42 pregnancies per 100 woman years exposure |
| DR-1011 | Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy | Compliant-Use (n=1685) | 1.77 pregnancies per 100 woman years exposure |
Primary
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
Time frame: up to one year
Population: The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DR-1011 | Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy | Excluding other BCMs (n=1732) | 2.15 pregnancies per 100 woman years exposure |
| DR-1011 | Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy | All complete cycles (n=1735) | 2.12 pregnancies per 100 woman years exposure |
| DR-1011 | Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy | Compliant-Use (n=1685) | 1.77 pregnancies per 100 woman years exposure |
Secondary
Participants With Treatment-Emergent Adverse Events
Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.
Time frame: Day 1 up to one year
Population: The safety cohort consisted of all patient who took at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DR-1011 | Participants With Treatment-Emergent Adverse Events | 1742 participants |