이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2013년 6월 13일 업데이트: Teva Women's Health

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

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

3597

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Alabama
      • Montgomery, Alabama, 미국, 36116
        • Teva Women's Health Research Investigational Site
    • Arizona
      • Phoenix, Arizona, 미국, 85015
        • Teva Women's Health Research Investigational Site
      • Phoenix, Arizona, 미국, 85037
        • Teva Women's Health Research Investigational Site
      • Tucson, Arizona, 미국, 85741
        • Teva Women's Health Research Investigational Site
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • Teva Women's Health Research Investigational Site
    • California
      • Anaheim, California, 미국, 92801
        • Teva Women's Health Research Investigational Site
      • Irvine, California, 미국, 92618
        • Teva Women's Health Research Investigational Site
      • Los Angeles, California, 미국, 90033
        • Teva Women's Health Research Investigational Site
      • National City, California, 미국, 91950
        • Teva Women's Health Research Investigational Site
      • San Diego, California, 미국, 29103
        • Teva Women's Health Research Investigational Site
      • San Diego, California, 미국, 92108
        • Teva Women's Health Research Investigational Site
      • San Diego, California, 미국, 92123
        • Teva Women's Health Research Investigational Site
      • San Francisco, California, 미국, 92103
        • Teva Women's Health Research Investigational Site
      • Torrance, California, 미국, 90502
        • Teva Women's Health Research Investigational Site
    • Colorado
      • Colorado Springs, Colorado, 미국, 80909
        • Teva Women's Health Research Investigational Site
      • Pueblo, Colorado, 미국, 81001
        • Teva Women's Health Research Investigational Site
    • District of Columbia
      • Washington, District of Columbia, 미국, 20036
        • Teva Women's Health Research Investigational Site
    • Florida
      • Clearwater, Florida, 미국, 33759
        • Teva Women's Health Research Investigational Site
      • Jacksonville, Florida, 미국, 32207
        • Teva Women's Health Research Investigational Site
      • Leesburg, Florida, 미국, 34748
        • Teva Women's Health Research Investigational Site
      • Miami, Florida, 미국, 33143
        • Teva Women's Health Research Investigational Site
      • Miami, Florida, 미국, 33186
        • Teva Women's Health Research Investigational Site
      • New Port Richey, Florida, 미국, 34652
        • Teva Women's Health Research Investigational Site
      • Palm Beach, Florida, 미국, 33409
        • Teva Women's Health Research Investigational Site
      • St. Petersburg, Florida, 미국, 33709
        • Teva Women's Health Research Investigational Site
      • Tampa, Florida, 미국, 33613
        • Teva Women's Health Research Investigational Site
      • West Palm Beach, Florida, 미국, 33401
        • Teva Women's Health Research Investigational Site
    • Georgia
      • Atlanta, Georgia, 미국, 30303
        • Teva Women's Health Research Investigational Site
      • Decatur, Georgia, 미국, 30034
        • Teva Women's Health Research Investigational Site
      • Roswell, Georgia, 미국, 30075
        • Teva Women's Health Research Investigational Site
      • Sandy Springs, Georgia, 미국, 30328
        • Teva Women's Health Research Investigational Site
      • Savannah, Georgia, 미국, 31406
        • Teva Women's Health Research Investigational Site
    • Idaho
      • Meridian, Idaho, 미국, 83642
        • Teva Women's Health Research Investigational Site
    • Illinois
      • Champaign, Illinois, 미국, 61820
        • Teva Women's Health Research Investigational Site
    • Kansas
      • Wichita, Kansas, 미국, 67207
        • Teva Women's Health Research Investigational Site
    • Kentucky
      • Lexington, Kentucky, 미국, 40509
        • Teva Women's Health Research Investigational Site
      • Louisville, Kentucky, 미국, 40291
        • Teva Women's Health Research Investigational Site
      • Mt Sterling, Kentucky, 미국, 40353
        • Teva Women's Health Research Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70808
        • Teva Women's Health Research Investigational Site
      • Metairie, Louisiana, 미국, 70006
        • Teva Women's Health Research Investigational Site
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • Teva Women's Health Research Investigational Site
    • Missouri
      • Kansas City, Missouri, 미국, 64108
        • Teva Women's Health Research Investigational Site
      • St. Louis, Missouri, 미국, 63117
        • Teva Women's Health Research Investigational Site
    • Nebraska
      • Lincoln, Nebraska, 미국, 68510
        • Teva Women's Health Research Investigational Site
    • Nevada
      • Las Vegas, Nevada, 미국, 89146
        • Teva Women's Health Research Investigational Site
    • New Jersey
      • Berlin, New Jersey, 미국, 08009
        • Teva Women's Health Research Investigational Site
      • Lawrenceville, New Jersey, 미국, 08648
        • Teva Women's Health Research Investigational Site
      • Moorestown, New Jersey, 미국, 08057
        • Teva Women's Health Research Investigational Site
      • New Brunswick, New Jersey, 미국, 08901
        • Teva Women's Health Research Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87102
        • Teva Women's Health Research Investigational Site
    • New York
      • Port Jefferson, New York, 미국, 11777
        • Teva Women's Health Research Investigational Site
      • Rochester, New York, 미국, 14609
        • Teva Women's Health Research Investigational Site
    • North Carolina
      • Cary, North Carolina, 미국, 27518
        • Teva Women's Health Research Investigational Site
      • Charlotte, North Carolina, 미국, 28209
        • Teva Women's Health Research Investigational Site
      • New Bern, North Carolina, 미국, 28562
        • Teva Women's Health Research Investigational Site
      • Raleigh, North Carolina, 미국, 27609
        • Teva Women's Health Research Investigational Site
      • Raleigh, North Carolina, 미국, 27612
        • Teva Women's Health Research Investigational Site
      • Salisbury, North Carolina, 미국, 28144
        • Teva Women's Health Research Investigational Site
      • Wilmington, North Carolina, 미국, 28401
        • Teva Women's Health Research Investigational Site
      • Winston-Salem, North Carolina, 미국, 27103
        • Teva Women's Health Research Investigational Site
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • Teva Women's Health Research Investigational Site
      • Columbus, Ohio, 미국, 43213
        • Teva Women's Health Research Investigational Site
    • Oklahoma
      • Edmond, Oklahoma, 미국, 73013
        • Teva Women's Health Research Investigational Site
      • Oklahoma City, Oklahoma, 미국, 73112
        • Teva Women's Health Research Investigational Site
    • Oregon
      • Eugene, Oregon, 미국, 97401
        • Teva Women's Health Research Investigational Site
      • Medford, Oregon, 미국, 97504
        • Teva Women's Health Research Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19114
        • Teva Women's Health Research Investigational Site
      • Pittsburgh, Pennsylvania, 미국, 15206
        • Teva Women's Health Research Investigational Site
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Teva Women's Health Research Investigational Site
      • Columbia, South Carolina, 미국, 29201
        • Teva Women's Health Research Investigational Site
      • Goose Creek, South Carolina, 미국, 29445
        • Teva Women's Health Research Investigational Site
      • Greenville, South Carolina, 미국, 29605
        • Teva Women's Health Research Investigational Site
      • Greer, South Carolina, 미국, 29651
        • Teva Women's Health Research Investigational Site
      • Hilton Head Island, South Carolina, 미국, 29926
        • Teva Women's Health Research Investigational Site
    • Tennessee
      • Bristol, Tennessee, 미국, 37620
        • Teva Women's Health Research Investigational Site
      • Jackson, Tennessee, 미국, 38305
        • Teva Women's Health Research Investigational Site
      • Knoxville, Tennessee, 미국, 37920
        • Teva Women's Health Research Investigational Site
      • Memphis, Tennessee, 미국, 38120
        • Teva Women's Health Research Investigational Site
      • Nashville, Tennessee, 미국, 37203
        • Teva Women's Health Research Investigational Site
    • Texas
      • Austin, Texas, 미국, 78759
        • Teva Women's Health Research Investigational Site
      • Dallas, Texas, 미국, 75234
        • Teva Women's Health Research Investigational Site
      • Dallas, Texas, 미국, 75390
        • Teva Women's Health Research Investigational Site
      • Ft. Worth, Texas, 미국, 76135
        • Teva Women's Health Research Investigational Site
      • Houston, Texas, 미국, 77054
        • Teva Women's Health Research Investigational Site
      • San Antonio, Texas, 미국, 78229
        • Teva Women's Health Research Investigational Site
      • Waco, Texas, 미국, 76712
        • Teva Women's Health Research Investigational Site
    • Utah
      • Salt Lake City, Utah, 미국, 84107
        • Teva Women's Health Research Investigational Site
    • Virginia
      • Arlington, Virginia, 미국, 22203
        • Teva Women's Health Research Investigational Site
      • Newport News, Virginia, 미국, 23602
        • Teva Women's Health Research Investigational Site
      • Norfolk, Virginia, 미국, 23502
        • Teva Women's Health Research Investigational Site
      • Norfolk, Virginia, 미국, 23507
        • Teva Women's Health Research Investigational Site
      • Richmond, Virginia, 미국, 23233
        • Teva Women's Health Research Investigational Site
    • Washington
      • Seattle, Washington, 미국, 98105
        • Teva Women's Health Research Investigational Site
      • Tacoma, Washington, 미국, 98405
        • Teva Women's Health Research Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

여성

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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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
실험적: 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.

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:
  • 레보노르게스트렐/에티닐 에스트라디올
  • 사중주®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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

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
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

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
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

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
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

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
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

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
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

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
Summary of Participants With Treatment-emergent Adverse Events
기간: 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.

Day 1 up to 13 months

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
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.
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
기간: 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.
Day 1 up to year 1

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 10월 1일

기본 완료 (실제)

2011년 9월 1일

연구 완료 (실제)

2011년 9월 1일

연구 등록 날짜

최초 제출

2009년 10월 15일

QC 기준을 충족하는 최초 제출

2009년 10월 15일

처음 게시됨 (추정)

2009년 10월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 6월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 6월 13일

마지막으로 확인됨

2013년 6월 1일

추가 정보

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. .

임신 예방에 대한 임상 시험

DR-103에 대한 임상 시험

3
구독하다