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

What Was Tested

This registered not phased trial tested Cetrorelix.

GnRH analogs are globally used for assisted reproduction in infertile patients.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

31 actual participants took part.

It was open to women only aged from 18 years up to 25 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: A BMI of 18 years old and \<18 and 25 years old and \>25. Menstrual cycles was within the range of 25\~31 days.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Cetrorelix and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Cetrorelix was given.

Those kept unaware of assignments: participant.

It started in 2006-04 with completion listed for 2007-02.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Day of the LH surge (time frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle).

It also tracked 1 secondary outcome, for example Serum LH concentrations.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 31 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, all human trials.