Phase 4
Completed N=42
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
| Outcome | Result | p-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
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.