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

13 de junho de 2013 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

3597

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 40 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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.

Outros nomes:
  • levonorgestrel/etinilestradiol
  • Quartette®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Teva Women's Health

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2009

Conclusão Primária (Real)

1 de setembro de 2011

Conclusão do estudo (Real)

1 de setembro de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

15 de outubro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de outubro de 2009

Primeira postagem (Estimativa)

16 de outubro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

24 de junho de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de junho de 2013

Última verificação

1 de junho de 2013

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DR-103-301

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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