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

13. Juni 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

3597

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: 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.

Andere Namen:
  • Levonorgestrel/Ethinylestradiol
  • Quartett®

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Teva Women's Health

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2009

Primärer Abschluss (Tatsächlich)

1. September 2011

Studienabschluss (Tatsächlich)

1. September 2011

Studienanmeldedaten

Zuerst eingereicht

15. Oktober 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Oktober 2009

Zuerst gepostet (Schätzen)

16. Oktober 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

24. Juni 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2013

Zuletzt verifiziert

1. Juni 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DR-103-301

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