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

13. června 2013 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

3597

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 40 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.

Ostatní jména:
  • levonorgestrel/ethinylestradiol
  • Quartette®

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Teva Women's Health

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. října 2009

Primární dokončení (Aktuální)

1. září 2011

Dokončení studie (Aktuální)

1. září 2011

Termíny zápisu do studia

První předloženo

15. října 2009

První předloženo, které splnilo kritéria kontroly kvality

15. října 2009

První zveřejněno (Odhad)

16. října 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

24. června 2013

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. června 2013

Naposledy ověřeno

1. června 2013

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • DR-103-301

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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