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NCT02234115 · OUTCOME

Efficacy of Leuprolide Mesylate (LMIS 50mg)

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma · Source last updated 2019-03-05

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

Measure
MEAN
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
baseline to 28 days, 28 days to 336 days

What was measured

The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).

Analysis population: ITT

Groups in this outcome

Leuprolide Mesylate 50mg

All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336. Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate

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

Analysis denominator · Participants

GroupSource count
Leuprolide Mesylate 50mg137

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Leuprolide Mesylate 50mg97.0Not reported92.298.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        92.2
        upper Limit
        98.9
        value
        97.0
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    units
    Participants
description
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).
dispersion Type
95% Confidence Interval
groups
  1. description
    All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336. Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
    id
    OG000
    title
    Leuprolide Mesylate 50mg
param Type
MEAN
population Description
ITT
reporting Status
POSTED
time Frame
baseline to 28 days, 28 days to 336 days
title
Efficacy of Leuprolide Mesylate (LMIS 50mg)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice