A Phase 3 interventional study of DR-103 in Pregnancy Prevention, sponsored by Teva Women's Health. Completed at 94 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by Teva Women's Health · Phase 3, Interventional, and Prevention
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.
Teva Women's Health is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: DR-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.
Also known as: levonorgestrel/ethinyl estradiol, Quartette®
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
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
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
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
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
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
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
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
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
| Milestone | DR-103 |
|---|---|
| Started | 3597 |
| Pregnancy intent-to-treat population | 3019 |
| Completed | 2144 |
| Not completed | 1453 |
| Withdrew: Adverse event | 466 |
| Withdrew: Lost to follow-up | 480 |
| Withdrew: Noncompliance with the protocol | 137 |
| Withdrew: Physician decision | 5 |
| Withdrew: Pregnancy | 68 |
| Withdrew: Protocol violation | 16 |
| Withdrew: Sponsor requested participant withdrawal | 35 |
| Withdrew: Withdrawal by subject | 217 |
| Withdrew: Other | 29 |
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)
| pregnancies / 100 woman years exposure | DR-103: Total | DR-103: <90 kg Subpopulation | 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 | 2.82 (2.1787 to 3.5920) | 2.46 (1.8111 to 3.2719) | 4.54 (2.6963 to 7.1601) |
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)
| pregnancies / 100 woman years exposure | DR-103: Total | DR-103: <90 kg Subpopulation | 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 | 3.25 (2.5101 to 4.1372) | 2.83 (2.0793 to 3.7556) | 5.32 (3.1636 to 8.3840) |
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)
| pregnancies / 100 woman years exposure | DR-103: Total | DR-103: <90 kg Subpopulation | 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 | 3.71 (2.8629 to 4.7173) | 3.23 (2.3742 to 4.2869) | 6.04 (3.5894 to 9.5044) |
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.
| pregnancies / cumulative exposure | DR-103: Total | DR-103: <90 kg Subpopulation | DR-103: >=90kg Subpopulation |
|---|---|---|---|
| Cycle 1 | 0.0074 (0.0048 to 0.0113) | 0.0060 (0.0035 to 0.0101) | 0.0139 (0.0066 to 0.0289) |
| Cycle 2 | 0.0134 (0.0097 to 0.0186) | 0.0114 (0.0077 to 0.0168) | 0.0231 (0.0129 to 0.0415) |
| Cycle 3 | 0.0212 (0.0162 to 0.0277) | 0.0185 (0.0135 to 0.0254) | 0.0339 (0.0205 to 0.0558) |
| Cycle 4 | 0.0272 (0.0213 to 0.0346) | 0.0239 (0.0179 to 0.0317) | 0.0429 (0.0270 to 0.0676) |
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)
| pregnancies / 100 woman years exposure | DR-103: Total | DR-103: <90 kg Subpopulation | 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 | 2.74 (2.1189 to 3.4975) | 2.40 (1.7618 to 3.1869) | 4.42 (2.6192 to 6.9735) |
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)
| pregnancies / 100 woman years exposure | DR-103: Total | DR-103: <90 kg Subpopulation | 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 | 2.92 (2.2558 to 3.7234) | 2.55 (1.8745 to 3.3905) | 4.72 (2.7973 to 7.4467) |
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)
| pregnancies / 100 woman years exposure | DR-103: Total | DR-103: <90 kg Subpopulation | 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 | 3.07 (2.3692 to 3.9105) | 2.68 (1.9696 to 3.5625) | 4.94 (2.9315 to 7.8034) |
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.
| participants | DR-103 |
|---|---|
| Treatment-emergent AEs (TEAEs) | 2605 |
| Treatment-related AEs | 1086 |
| Serious AEs | 58 |
| TEAEs leading to discontinuation | 463 |
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.
| pregnancies / cumulative exposure | DR-103: Total | DR-103: <90 kg Subpopulation | DR-103: >=90kg Subpopulation |
|---|---|---|---|
| Cycle 1 | 0.0080 (0.0044 to 0.0144) | 0.0062 (0.0030 to 0.0130) | 0.0164 (0.0062 to 0.0431) |
| Cycle 2 | 0.0134 (0.0083 to 0.0215) | 0.0116 (0.0066 to 0.0204) | 0.0215 (0.0090 to 0.0511) |
| Cycle 3 | 0.0236 (0.0162 to 0.0344) | 0.0203 (0.0129 to 0.0317) | 0.0392 (0.0196 to 0.0776) |
| Cycle 4 | 0.0291 (0.0206 to 0.0412) | 0.0256 (0.0170 to 0.0385) | 0.0457 (0.0238 to 0.0871) |
Collected over Day 1 - one year and three weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DR-103 | — | 58/3,597 (1.6%) | 1,567/3,597 (43.6%) |
| Event | DR-103 |
|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 5/3597 |
| Suicide attemptPsychiatric disorders | 5/3597 |
| Deep vein thrombosisVascular disorders | 3/3597 |
| Abdominal painGastrointestinal disorders | 3/3597 |
| PneumoniaInfections and infestations | 2/3597 |
| ConvulsionNervous system disorders | 2/3597 |
| CholecystitisHepatobiliary disorders | 2/3597 |
| CholelithiasisHepatobiliary disorders | 2/3597 |
| OverdoseInjury, poisoning and procedural complications | 2/3597 |
| AppendicitisInfections and infestations | 2/3597 |
| Event | DR-103 |
|---|---|
| HeadacheNervous system disorders | 420/3597 |
| NasopharyngitisInfections and infestations | 342/3597 |
| Upper respiratory tract infectionInfections and infestations | 323/3597 |
| SinusitisInfections and infestations | 246/3597 |
| NauseaGastrointestinal disorders | 241/3597 |
| MetrorrhagiaReproductive system and breast disorders | 216/3597 |
| Urinary tract infectionInfections and infestations | 214/3597 |
| AcneSkin and subcutaneous tissue disorders | 193/3597 |
| DysmenorrhoeaReproductive system and breast disorders | 188/3597 |
Safety population: participants who took at least one dose of intervention.
| Age Continuous(years) | DR-103 |
|---|---|
| Mean | 27.4 ± 7.0 |
| Sex: Female, Male(Participants) | DR-103 |
|---|---|
| Female | 3597 |
| Male | 0 |
| Race/Ethnicity, Customized(participants) | DR-103 |
|---|---|
| American Indian or Alaska Native | 14 |
| Asian | 78 |
| Native Hawaiian or Other Pacific Islander | 10 |
| Black or African American | 696 |
| White | 2324 |
| Hispanic or Latino | 404 |
| Other | 71 |
| Height(inches) | DR-103 |
|---|---|
| Mean | 64.6 ± 2.7 |
| Weight(pounds) | DR-103 |
|---|---|
| Mean | 162.5 ± 43.2 |
| Body Mass Index(kg/m^2) | DR-103 |
|---|---|
| Mean | 27.4 ± 7.0 |
| Systolic Blood Pressure(mmHg) | DR-103 |
|---|---|
| Mean | 113.1 ± 10.4 |
| Diastolic Blood Pressure(mmHg) | DR-103 |
|---|---|
| Mean | 72.3 ± 8.3 |
3 further baseline measures are reported on the registry.
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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