Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01185782 · OUTCOME

Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter

SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women · Source last updated 2013-12-27

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

Measure
MEAN
Unit
IU
Interval / dispersion
Standard Deviation
Time frame
Start of treatment period until Day 1 of post-treatment assessment period

What was measured

Total dose of IMP administered was defined as the cumulative dose administered from the start of treatment with IMP until the mean diameter of the dominant follicle reached 18 mm.

Analysis population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis of this parameter.

Groups in this outcome

SJ-0021

SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.

u-hFSH

Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.

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

Analysis denominator · Participants

GroupSource count
SJ-0021117
u-hFSH125

Reported measurements

Source class 1
Values in IU · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SJ-0021959.29533.32Not reportedNot reportedNot reported
u-hFSH845.70432.88Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.069
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.069
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        533.32
        value
        959.29
      2. group Id
        OG001
        spread
        432.88
        value
        845.70
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      125
    units
    Participants
description
Total dose of IMP administered was defined as the cumulative dose administered from the start of treatment with IMP until the mean diameter of the dominant follicle reached 18 mm.
dispersion Type
Standard Deviation
groups
  1. description
    SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
    id
    OG000
    title
    SJ-0021
  2. description
    Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
    id
    OG001
    title
    u-hFSH
param Type
MEAN
population Description
FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis of this parameter.
reporting Status
POSTED
time Frame
Start of treatment period until Day 1 of post-treatment assessment period
title
Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter
type
SECONDARY
unit Of Measure
IU

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice