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Completed

NCT Number: NCT00628121

Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer

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.

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Key information

Conditions

Premenopause Genital Diseases Infertility Urogenital Diseases

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kitasato University East Hospital

Sagamihara, Kanagawa, 228-8520, Japan

About this study

To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and also examined the mode of disappearance of pulsatile LH secretion during the cetrorelix administration menstrual cycle.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a BMI of 18 years old and <18 and 25 years old and >25
  • menstrual cycles was within the range of 25~31 days

Exclusion criteria

  • use of a drug (e.g., oral contraceptives, drugs for treatment of hyperprolactinemia, GnRH agonists, sex steroid hormones, psychoactive drugs, etc.)
  • serious disease of the endocrine system, liver, kidney, heart, lung, digestive system, etc.
  • a generalized drug allergy

Treatment and study plan

Cetrorelix

Drug

1, 2 or 3mg, subcutaneouly dosed with single dose

Other names: NS75A

Primary outcomes

  1. Day of the LH surge

    Time frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle

Secondary outcomes

  1. Serum LH concentrations

    Time frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle

Sponsors and collaborators

Lead sponsor

Nippon Kayaku Co., Ltd.

Industry

Collaborators

  • AEterna Zentaris
  • Shionogi

Registry information

Official study title

Clinical Pharmacological Study of NS75A for Healthy Adult Women

Important dates

Study start
2006
Study completion
2007
First posted
Mar 4, 2008
Registry last updated
Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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