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Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

26. juni 2014 opdateret af: Repros Therapeutics Inc.

A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids

Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • Jundiaí, Brasilien, 13209-000
        • Vox Femina
      • São Paulo, Brasilien, 08270-070
        • Hospital Santa Marcelina
      • São Paulo, Brasilien, 01416-000
        • Brazilmed
      • São Paulo, Brasilien, 04015-001
        • Universidade Federal de São Paulo - UNIFESP
      • São Paulo, Brasilien, 04039-901
        • Hospital dos Servidores Públicos de SP
      • São Paulo, Brasilien, 04230 - 000
        • Hospital Heliopolis
    • Paraná.
      • Curitiba, Paraná., Brasilien, 80030-220
        • Cepeme/Cerfahc
  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater, 92103
        • Genesis Center for Clinical Research
    • Florida
      • Sarasota, Florida, Forenede Stater, 34239
        • Physician Care Clinical Research, LLC
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Atlanta Women's Research Inst.
      • Decatur, Georgia, Forenede Stater, 30034
        • Soapstone Center for Clinical Research
    • Louisiana
      • Marrero, Louisiana, Forenede Stater, 70072
        • York Clinical Consulting
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Female Pelvic Medicine
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Hawthorne Medical Research, Inc.
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Lyndhurst Gynecologic Associates
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97408
        • Clinical Trials of America
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107-5127
        • Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Women's Care Center, PLC Research Memphis Associates
      • Nashville, Tennessee, Forenede Stater, 37208
        • Meharry Medical College
    • Texas
      • Plano, Texas, Forenede Stater, 75093
        • Willowbend Health & Wellness Associates

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
  • Subject must have uterine fibroid-associated symptoms during the-screening visit
  • Subject has menstrual cycle lasting from 20 to 40 days
  • Other inclusion criteria may apply

Exclusion Criteria:

  • Post-menopausal women or women likely to become post-menopausal during the study
  • Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
  • Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
  • Subject who has had an acute illness within five days of study medication administration
  • Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
  • Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
  • Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 25 mg
25 mg Proellex
Medicin: Proellex
One 25mg capsule taken orally once every day.
Andre navne:
  • Telapristonacetat
Medicin: Proellex
Two 25mg capsules Proellex (50mg) taken orally once every day
Andre navne:
  • Telapristonacetat
Eksperimentel: 50 mg
50 mg Proellex
Medicin: Proellex
One 25mg capsule taken orally once every day.
Andre navne:
  • Telapristonacetat
Medicin: Proellex
Two 25mg capsules Proellex (50mg) taken orally once every day
Andre navne:
  • Telapristonacetat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
Tidsramme: Four months each cycle
Four months each cycle

Sekundære resultatmål

Resultatmål
Tidsramme
To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
Tidsramme: Two, 4 month cycles
Two, 4 month cycles

Samarbejdspartnere og efterforskere

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

Sponsor

Repros Therapeutics Inc.

Efterforskere

  • Studieleder: Andre van As, MD, PhD, Repros Therapeutics Inc.

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.

Datoer for studieregistrering

Først indsendt

31. marts 2009

Først indsendt, der opfyldte QC-kriterier

31. marts 2009

Først opslået (Skøn)

2. april 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZPU-306

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 .

Kliniske forsøg med Uterine fibromer

Kliniske forsøg med Proellex

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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