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NCT03242590 · OUTCOME

Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range

Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). · Source last updated 2019-10-23

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

Measure
NUMBER
Unit
Percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
Following 24 days of treatment

What was measured

The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days).

Analysis population: Safety Set

Groups in this outcome

Oral Testosterone Undecanoate, LPCN 1021

Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate

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

Analysis denominator · Participants

GroupSource count
Oral Testosterone Undecanoate, LPCN 102195

Reported measurements

Source class 1
Values in Percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Oral Testosterone Undecanoate, LPCN 102180Not reported7288Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        72
        upper Limit
        88
        value
        80
denoms
  1. counts
    1. group Id
      OG000
      value
      95
    units
    Participants
description
The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days).
dispersion Type
95% Confidence Interval
groups
  1. description
    Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
    id
    OG000
    title
    Oral Testosterone Undecanoate, LPCN 1021
param Type
NUMBER
population Description
Safety Set
reporting Status
POSTED
time Frame
Following 24 days of treatment
title
Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
type
PRIMARY
unit Of Measure
Percent of participants

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

Preserved source evidence · Not medical advice