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

13 czerwca 2013 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

3597

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 40 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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.

Inne nazwy:
  • lewonorgestrel/etynyloestradiol
  • Kwartet®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Teva Women's Health

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2009

Zakończenie podstawowe (Rzeczywisty)

1 września 2011

Ukończenie studiów (Rzeczywisty)

1 września 2011

Daty rejestracji na studia

Pierwszy przesłany

15 października 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 października 2009

Pierwszy wysłany (Oszacować)

16 października 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

24 czerwca 2013

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 czerwca 2013

Ostatnia weryfikacja

1 czerwca 2013

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • DR-103-301

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zapobieganie ciąży

  • Bambino Gesù Hospital and Research Institute
    Zakończony
    Obalon u dzieci z ciężką otyłością (Obalon)
    Ciężka otyłość dziecięca (BMI > 97° szt. -według wykresów BMI Centers for Disease Control and Prevention-) | Zmienione testy czynnościowe wątroby | Nietolerancja glikemiczna
    Włochy

Badania kliniczne na DR-103

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Uruguay

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
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