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NCT01185782 · OUTCOME

Percentage of Participants With Ovulation

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]

What was measured

Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.

Analysis population: Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc.

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-0021129
u-hFSH132

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SJ-002179.1Not reportedNot reportedNot reportedNot reported
u-hFSH82.6Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -13.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.04
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.")
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Delta
    param Value
    -3.51
    statistical Method
    Chi-squared
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Lower Limit
    -13.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.04
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.")
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Delta
    param Value
    -3.51
    statistical Method
    Chi-squared
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        79.1
      2. group Id
        OG001
        value
        82.6
denoms
  1. counts
    1. group Id
      OG000
      value
      129
    2. group Id
      OG001
      value
      132
    units
    Participants
description
Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.
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
NUMBER
population Description
Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc.
reporting Status
POSTED
time Frame
On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]
title
Percentage of Participants With Ovulation
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice