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NCT00295750 · OUTCOME

Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer · Source last updated 2012-12-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Day 252, Day 255, and Day 259

What was measured

Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \<=-0.25, \>-0.25-0, \>0-0.25, \>0.25-0.5 and \>0.5 ng/mL from mean testosterone levels on Day 252.

Analysis population: ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.

Groups in this outcome

Degarelix 240/160 mg

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.

Degarelix 240/80 mg

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.

Leuprolide 7.5 mg

Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Degarelix 240/160 mg176
Degarelix 240/80 mg178
Leuprolide 7.5 mg179

Reported measurements

<=-0.25 ng/mL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg1Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg3Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg0Not reportedNot reportedNot reportedNot reported
>-0.25-0 ng/mL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg84Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg85Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg49Not reportedNot reportedNot reportedNot reported
>0-0.25 ng/mL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg91Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg90Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg122Not reportedNot reportedNot reportedNot reported
>0.25-0.5 ng/mL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg0Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg0Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg5Not reportedNot reportedNot reportedNot reported
>0.5 ng/mL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg0Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg0Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
    title
    <=-0.25 ng/mL
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        85
      3. group Id
        OG002
        value
        49
    title
    >-0.25-0 ng/mL
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        90
      3. group Id
        OG002
        value
        122
    title
    >0-0.25 ng/mL
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5
    title
    >0.25-0.5 ng/mL
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
    title
    >0.5 ng/mL
denoms
  1. counts
    1. group Id
      OG000
      value
      176
    2. group Id
      OG001
      value
      178
    3. group Id
      OG002
      value
      179
    units
    Participants
description
Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \<=-0.25, \>-0.25-0, \>0-0.25, \>0.25-0.5 and \>0.5 ng/mL from mean testosterone levels on Day 252.
groups
  1. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
    id
    OG000
    title
    Degarelix 240/160 mg
  2. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
    id
    OG001
    title
    Degarelix 240/80 mg
  3. description
    Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
    id
    OG002
    title
    Leuprolide 7.5 mg
param Type
NUMBER
population Description
ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.
reporting Status
POSTED
time Frame
Day 252, Day 255, and Day 259
title
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice