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

13 giugno 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

3597

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 40 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.

Altri nomi:
  • levonorgestrel/etinilestradiolo
  • Quartetto®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Teva Women's Health

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2009

Completamento primario (Effettivo)

1 settembre 2011

Completamento dello studio (Effettivo)

1 settembre 2011

Date di iscrizione allo studio

Primo inviato

15 ottobre 2009

Primo inviato che soddisfa i criteri di controllo qualità

15 ottobre 2009

Primo Inserito (Stima)

16 ottobre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 giugno 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 giugno 2013

Ultimo verificato

1 giugno 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DR-103-301

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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