A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
- Registration Number
- NCT00996580
- Lead Sponsor
- Teva Women's Health
- Brief Summary
This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3597
- Sexually active at risk for pregnancy
- Agreement to use study OC therapy as their only method of birth control during the study
- history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
- Others as dictated by FDA-approved protocol
- Any contraindication to the use of oral contraceptives
- Pregnancy or plans to become pregnant in the next 14 months
- Smoker and age ≥ 35 years
- Others as dictated by FDA-approved protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DR-103 DR-103 Four 91-day cycles of the DR-103 regimen: * 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; * 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; * 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; * 7 days of 10 mcg EE.
- Primary Outcome Measures
Name Time Method All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight Day 1 up to year 1 Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight Day 1 up to year 1 Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight Day 1 up to year 1 Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight Day 1 up to year 1 Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles)Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight Day 1 up to year 1 Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles)Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight Day 1 up to year 1 Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.
In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.
The PI is defined as number of contraceptive failures per 100 women-years of exposure:
(100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles)Summary of Participants With Treatment-emergent Adverse Events Day 1 up to 13 months The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date.
Relationship to study drug was assessed by the investigator.
Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention.
- Secondary Outcome Measures
Name Time Method All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight Day 1 up to year 1 A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight Day 1 up to year 1 A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.
Trial Locations
- Locations (1)
Teva Women's Health Research Investigational Site
🇺🇸Tacoma, Washington, United States