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Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

28. september 2016 opdateret af: Duramed Research

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. 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)

2235

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
      • Huntsville, Alabama, Forenede Stater, 35801
        • Duramed Investigational Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Duramed Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85031
        • Duramed Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85032
        • Duramed Investigational Site
      • Tucson, Arizona, Forenede Stater, 85712
        • Duramed Investigational Site
    • California
      • San Diego, California, Forenede Stater, 92108
        • Duramed Investigational Site
      • San Diego, California, Forenede Stater, 92103
        • Duramed Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Duramed Investigational Site
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Duramed Investigational Site
      • Denver, Colorado, Forenede Stater, 80202
        • Duramed Investigational Site
    • Connecticut
      • New London, Connecticut, Forenede Stater, 06320
        • Duramed Investigational Site
    • Florida
      • Coral Cables, Florida, Forenede Stater, 33134
        • Duramed Investigational Site
      • Hollywood, Florida, Forenede Stater, 33024
        • Duramed Investigational Site
      • Jacksonville, Florida, Forenede Stater, 32216
        • Duramed Investigational Site
      • Leesburg, Florida, Forenede Stater, 34748
        • Duramed Investigational Site
      • Miami, Florida, Forenede Stater, 33143
        • Duramed Investigational Site
      • Palm Springs, Florida, Forenede Stater, 33437
        • Duramed Investigational Site
      • Sarasota, Florida, Forenede Stater, 34239
        • Duramed Investigational Site
      • Tampa, Florida, Forenede Stater, 33607
        • Duramed Investigational Site
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30034
        • Duramed Investigational Site
      • Douglasville, Georgia, Forenede Stater, 30134
        • Duramed Investigational Site
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
        • Duramed Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Duramed Investigational Site
    • Kansas
      • Shawnee Mission, Kansas, Forenede Stater, 66216
        • Duramed Investigational Site
      • Topeka, Kansas, Forenede Stater, 66614
        • Duramed Investigational Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40291
        • Duramed Investigational Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64106
        • Duramed Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63110
        • Duramed Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, Forenede Stater, 08648
        • Duramed Investigational Site
      • Moorestown, New Jersey, Forenede Stater, 08057
        • Duramed Investigational Site
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Duramed Investigational Site
    • New York
      • Rochester, New York, Forenede Stater, 14609
        • Duramed Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28222
        • Duramed Investigational Site
      • Wilmington, North Carolina, Forenede Stater, 28412
        • Duramed Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Duramed Investigational Site
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43213
        • Duramed Investigational Site
      • Columbus, Ohio, Forenede Stater, 43205
        • Duramed Investigational Site
    • Oklahoma
      • Oklahoma, Oklahoma, Forenede Stater, 73112
        • Duramed Investigational Site
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Duramed Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Duramed Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15206
        • Duramed Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Duramed Investigational Site
      • Willow Grove, Pennsylvania, Forenede Stater, 19090
        • Duramed Investigational Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • Duramed Investigational Site
      • Houston, Texas, Forenede Stater, 77030
        • Duramed Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Duramed Investigational Site
      • Waco, Texas, Forenede Stater, 76712
        • Duramed Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Duramed Investigational Site
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23602
        • Duramed Investigational Site
      • Norfolk, Virginia, Forenede Stater, 23507
        • Duramed Investigational Site
      • Richmond, Virginia, Forenede Stater, 23226
        • Duramed Investigational Site
    • Washington
      • Lakewood, Washington, Forenede Stater, 98499
        • Duramed Investigational Site
      • Seattle, Washington, Forenede Stater, 98105
        • Duramed Investigational Site
      • Spokane, Washington, Forenede Stater, 99207
        • Duramed Investigational Site
      • Tacoma, Washington, Forenede Stater, 98405
        • Duramed 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

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Premenopausal
  • Not pregnant or breastfeeding
  • Sexually active at risk of pregnancy

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  • Pregnancy within the last 3 months
  • Smoking > 10 cigarettes per day

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-1011
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
Medicin: DR-1011
Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
Andre navne:
  • levonorgestrel/ethinylestradiol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Tidsramme: up to one year

Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.

The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication.

Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication.

Three denominators are reported;

  • excluding cycles where other birth control methods (BCMs) was used
  • all complete cycles
  • compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
up to one year
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Tidsramme: up to one year

Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.

The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication.

Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication.

Three denominators are reported;

  • excluding cycles where other birth control methods (BCMs) was used
  • all complete cycles
  • compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
up to one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participants With Treatment-Emergent Adverse Events
Tidsramme: Day 1 up to one year
Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.
Day 1 up to one year

Samarbejdspartnere og efterforskere

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

Sponsor

Duramed Research

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. juni 2005

Primær færdiggørelse (Faktiske)

1. juni 2007

Studieafslutning (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først indsendt

12. september 2005

Først indsendt, der opfyldte QC-kriterier

14. september 2005

Først opslået (Skøn)

20. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DR-PSE-309

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 .

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