日本人不妊女性における排卵誘発のためのSJ-0021（ゴナレフ®）と精製下垂体ゴナドトロピン（フェルティノルム-P®）の比較

基本情報

NCT ID

NCT01185782

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

300

治験依頼者名

Merck KGaA, Darmstadt, Germany

概要

Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)