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COL-1620膣プロゲステロンゲルの有効性および安全性を評価する第3相臨床試験
基本情報
- NCT ID
- NCT01863680
- 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
- 178
- 治験依頼者名
- Merck KGaA, Darmstadt, Germany
概要
The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology \[JSOG\] 2009 registry data: 24.3 percent \[%\]). The secondary objectives of this trial are to assess the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.
対象疾患
Luteal Hormone Supplementation in In-vitro FertilizationEmbryo Transfer
介入
COL-1620(DRUG)
Gonadotropin-releasing hormone (GnRH) analogue(DRUG)
Follicle-stimulating hormone (FSH)(DRUG)
Human Chorionic Gonadotropin (hCG)(DRUG)
依頼者（Sponsor）
Merck Kgaa, Darmstadt, Germany(INDUSTRY)