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健康な女性ボランティアを対象としたGnRH拮抗薬セトロレリクスの臨床薬理学的研究

基本情報

NCT ID
NCT00628121
ステータス
完了
試験のフェーズ
該当なし
試験タイプ
介入
目標被験者数
31
治験依頼者名
Nippon Kayaku Co., Ltd.

概要

GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent prolongation of the duration of LH suppression. However, there have been few reports of studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the present study, we investigated the effect of cetrorelix on LH surge when this drug was administered in single doses of 1, 2 and 3 mg.

対象疾患

Premenopause

介入

Cetrorelix(DRUG)

依頼者(Sponsor)

実施施設 (1)

医療法人社団イースト会 新宿東口イースト駅前クリニック

Sagamihara, Kanagawa, Japan