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

13. juni 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3597

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Andre navne:
  • levonorgestrel/ethinylestradiol
  • Quartette®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Teva Women's Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. september 2011

Datoer for studieregistrering

Først indsendt

15. oktober 2009

Først indsendt, der opfyldte QC-kriterier

15. oktober 2009

Først opslået (Skøn)

16. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DR-103-301

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner