Participant flow

Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women · Source last updated 2016-01-07

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

groups

1. description

   Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (\>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of \>=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).

   id

   FG000

   title

   MSJ-0011

2. description

   Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of \>=18 mm; not more than 3 follicles each with a mean diameter of \>=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.

   id

   FG001

   title

   u-hCG

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Investigator discretion

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         27

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         27

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice