- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00996580
A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
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
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Alabama
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Montgomery, Alabama, 미국, 36116
- Teva Women's Health Research Investigational Site
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Arizona
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Phoenix, Arizona, 미국, 85015
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Phoenix, Arizona, 미국, 85037
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Tucson, Arizona, 미국, 85741
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Arkansas
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Little Rock, Arkansas, 미국, 72205
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California
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Anaheim, California, 미국, 92801
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Irvine, California, 미국, 92618
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Los Angeles, California, 미국, 90033
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National City, California, 미국, 91950
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San Diego, California, 미국, 29103
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San Diego, California, 미국, 92108
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San Diego, California, 미국, 92123
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San Francisco, California, 미국, 92103
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Torrance, California, 미국, 90502
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Colorado
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Colorado Springs, Colorado, 미국, 80909
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Pueblo, Colorado, 미국, 81001
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District of Columbia
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Washington, District of Columbia, 미국, 20036
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Florida
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Clearwater, Florida, 미국, 33759
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Jacksonville, Florida, 미국, 32207
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Leesburg, Florida, 미국, 34748
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Miami, Florida, 미국, 33143
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Miami, Florida, 미국, 33186
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New Port Richey, Florida, 미국, 34652
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Palm Beach, Florida, 미국, 33409
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St. Petersburg, Florida, 미국, 33709
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Tampa, Florida, 미국, 33613
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West Palm Beach, Florida, 미국, 33401
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Georgia
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Atlanta, Georgia, 미국, 30303
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Decatur, Georgia, 미국, 30034
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Roswell, Georgia, 미국, 30075
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Sandy Springs, Georgia, 미국, 30328
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Savannah, Georgia, 미국, 31406
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Idaho
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Meridian, Idaho, 미국, 83642
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Illinois
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Champaign, Illinois, 미국, 61820
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Kansas
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Wichita, Kansas, 미국, 67207
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Kentucky
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Lexington, Kentucky, 미국, 40509
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Louisville, Kentucky, 미국, 40291
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Mt Sterling, Kentucky, 미국, 40353
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Louisiana
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Baton Rouge, Louisiana, 미국, 70808
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Metairie, Louisiana, 미국, 70006
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Maryland
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Baltimore, Maryland, 미국, 21201
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Missouri
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Kansas City, Missouri, 미국, 64108
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St. Louis, Missouri, 미국, 63117
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Nebraska
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Lincoln, Nebraska, 미국, 68510
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Nevada
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Las Vegas, Nevada, 미국, 89146
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New Jersey
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Berlin, New Jersey, 미국, 08009
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Lawrenceville, New Jersey, 미국, 08648
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Moorestown, New Jersey, 미국, 08057
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New Brunswick, New Jersey, 미국, 08901
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New Mexico
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Albuquerque, New Mexico, 미국, 87102
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New York
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Port Jefferson, New York, 미국, 11777
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Rochester, New York, 미국, 14609
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North Carolina
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Cary, North Carolina, 미국, 27518
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Charlotte, North Carolina, 미국, 28209
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New Bern, North Carolina, 미국, 28562
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Raleigh, North Carolina, 미국, 27609
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Raleigh, North Carolina, 미국, 27612
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Salisbury, North Carolina, 미국, 28144
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Wilmington, North Carolina, 미국, 28401
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Winston-Salem, North Carolina, 미국, 27103
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Ohio
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Columbus, Ohio, 미국, 43210
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Columbus, Ohio, 미국, 43213
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Oklahoma
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Edmond, Oklahoma, 미국, 73013
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Oklahoma City, Oklahoma, 미국, 73112
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Oregon
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Eugene, Oregon, 미국, 97401
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Medford, Oregon, 미국, 97504
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19114
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Pittsburgh, Pennsylvania, 미국, 15206
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South Carolina
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Charleston, South Carolina, 미국, 29425
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Columbia, South Carolina, 미국, 29201
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Goose Creek, South Carolina, 미국, 29445
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Greenville, South Carolina, 미국, 29605
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Greer, South Carolina, 미국, 29651
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Hilton Head Island, South Carolina, 미국, 29926
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Tennessee
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Bristol, Tennessee, 미국, 37620
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Jackson, Tennessee, 미국, 38305
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Knoxville, Tennessee, 미국, 37920
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Memphis, Tennessee, 미국, 38120
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Nashville, Tennessee, 미국, 37203
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Texas
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Austin, Texas, 미국, 78759
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Dallas, Texas, 미국, 75234
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Dallas, Texas, 미국, 75390
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Ft. Worth, Texas, 미국, 76135
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Houston, Texas, 미국, 77054
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San Antonio, Texas, 미국, 78229
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Waco, Texas, 미국, 76712
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Utah
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Salt Lake City, Utah, 미국, 84107
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Virginia
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Arlington, Virginia, 미국, 22203
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Newport News, Virginia, 미국, 23602
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Norfolk, Virginia, 미국, 23502
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Norfolk, Virginia, 미국, 23507
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Richmond, Virginia, 미국, 23233
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Washington
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Seattle, Washington, 미국, 98105
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Tacoma, Washington, 미국, 98405
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: DR-103
Four 91-day cycles of the DR-103 regimen:
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
기간: Day 1 up to year 1
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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) |
Day 1 up to year 1
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Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
기간: Day 1 up to year 1
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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) |
Day 1 up to year 1
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Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
기간: Day 1 up to year 1
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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) |
Day 1 up to year 1
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All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
기간: Day 1 up to year 1
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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) |
Day 1 up to year 1
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Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
기간: Day 1 up to year 1
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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) |
Day 1 up to year 1
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Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
기간: Day 1 up to year 1
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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) |
Day 1 up to year 1
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Summary of Participants With Treatment-emergent Adverse Events
기간: Day 1 up to 13 months
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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. |
Day 1 up to 13 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
기간: Day 1 up to year 1
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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.
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Day 1 up to year 1
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Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
기간: Day 1 up to year 1
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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.
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Day 1 up to year 1
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Poindexter A, Reape KZ, Hait H. Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo. Contraception. 2008 Aug;78(2):113-9. doi: 10.1016/j.contraception.2008.04.001. Epub 2008 Jun 2.
- Portman DJ, Kaunitz AM, Howard B, Weiss H, Hsieh J, Ricciotti N. Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive. Contraception. 2014 Apr;89(4):299-306. doi: 10.1016/j.contraception.2014.01.013. Epub 2014 Jan 29.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DR-103-301
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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