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

Clinical Pharmacological Study of NS75A for Healthy Adult Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628121

Enrollment

Registered

2008-03-04

Start date

2006-04-30

Completion date

2007-02-28

Last updated

2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenopause

Keywords

infertility, menstrual cycle, LH surge

Brief summary

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.

Detailed description

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.

Interventions

DRUGCetrorelix

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 25 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Day of the LH surge	Saline administration menstrual cycle, cetrorelix administration menstrual cycle

Secondary

Measure	Time frame
Serum LH concentrations	Saline administration menstrual cycle, cetrorelix administration menstrual cycle

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026