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

2013年6月13日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

3597

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：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.

其他名称：
  • 左炔诺孕酮/炔雌醇
  • 四重奏®

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Teva Women's Health

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年10月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2009年10月15日

首先提交符合 QC 标准的

2009年10月15日

首次发布 (估计)

2009年10月16日

研究记录更新

最后更新发布 (估计)

2013年6月24日

上次提交的符合 QC 标准的更新

2013年6月13日

最后验证

2013年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • DR-103-301

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

DR-103的临床试验

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赞助者和合作者

医疗条件

药物干预

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CROs in Ireland

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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