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

13. juni 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

3597

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 40 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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 navn:
  • levonorgestrel/etinylestradiol
  • Quartette®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Teva Women's Health

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2009

Primær fullføring (Faktiske)

1. september 2011

Studiet fullført (Faktiske)

1. september 2011

Datoer for studieregistrering

Først innsendt

15. oktober 2009

Først innsendt som oppfylte QC-kriteriene

15. oktober 2009

Først lagt ut (Anslag)

16. oktober 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. juni 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juni 2013

Sist bekreftet

1. juni 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DR-103-301

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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