A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier:
NCT00996580
First received: October 15, 2009
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Pregnancy Prevention
Drug: DR-103
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight [ Time Frame: Day 1 up to year 1 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 up to year 1 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 up to year 1 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 up to year 1 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 up to year 1 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 up to year 1 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 up to 13 months ] [ Designated as safety issue: Yes ]

    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:
  • All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight [ Time Frame: Day 1 up to year 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 up to year 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 3597
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

Other Names:
  • levonorgestrel/ethinyl estradiol
  • Quartette®

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sexually active at risk for pregnancy
  • Agreement to use study OC therapy as their only method of birth control during the study
  • history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
  • Others as dictated by FDA-approved protocol

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  • Pregnancy or plans to become pregnant in the next 14 months
  • Smoker and age ≥ 35 years
  • Others as dictated by FDA-approved protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996580

  Show 94 Study Locations
Sponsors and Collaborators
Teva Women's Health
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier: NCT00996580     History of Changes
Other Study ID Numbers: DR-103-301
Study First Received: October 15, 2009
Results First Received: April 26, 2013
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Contraception
Oral contraceptives

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Estradiol
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on July 20, 2014