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Phase 4 Completed N=42 Treatment

Evaluate Recovery of Testosterone for Patients Using Eligard

Source: ClinicalTrials.gov NCT01136226 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Serum Testosterone Recovery — 6 Months

Summary

The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.

Outcome Measures

OutcomeResultp-value
PRIMARY
Serum Testosterone Recovery
6
SECONDARY
Safety Assessments

Eligibility Criteria

Inclusion Criteria

  • Must be outpatient, not hospitalized
  • Male Patient between ages 50-80, inclusive
  • Histologically/Cytologically graded adenocarcinoma of the prostate
  • Must have T1, T2 or T3a adenocarcinoma of the prostate
  • Must be a candidate for radiation therapy. Hormone refractory patients excluded
  • WHO/ECOG score of 0,1 or 2

Exclusion Criteria

  • NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator.
  • Used the following treatments for prostate Cancer

*immunotherapy *chemotherapy *External Beam Radiation *brachytherapy *hormonal therapy *biological response modifiers

  • Prior Prostate Surgery (excluding TUNA or TURP)
  • Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs
  • Use of Investigational Drug, Biologic or device within five half-lives of its physiological action or three months prior to base line, whichever is longer
  • Over the counter or alternative medical therapies which have estrogenic or anti-androgenic effect
  • uncontrolled CHF within 6 months to baseline
  • Myocardial Infarct, coronary vascular procedure or Clinically SignificantCardiovascualr Disease within 6 months of baseline Visit
  • Venous thrombosis with in 6 Months of Screening
  • Uncontrolled Hypertension defined as >170/100 or Symptomatic Hypotension within 3 months of Baseline
  • Insulin dependant Diabetic Patients Must not administer in an anatomic region where they will receive Eligard.
  • Drug or Alcohol Abuse 6 months prior to Baseline
  • Other Serious Illness at the discretion of the Investigator
  • Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose for 3 months prior to Baseline
  • Hypersensitivity to GnRH, GnRH agonists
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01136226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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