A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism

What Was Tested

In this phase 3 trial, researchers set out to test hCG (human chorionic gonadotropin).

The registry classes the interventions as drug.

More on the Plan

The study was organized on an outpatient basis involving a single cycle of treatment.

Prior to entry into the study, the diagnosis of hypogonadotropic hypogonadism was confirmed by history, by the presence or absence of specific clinical features and by measuring serum gonadotropin levels.

Luteal phase function was assessed by serum progesterone level determination.

Who Took Part

31 actual participants took part.

It was open to women only.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be premenopausal, between 18 and 39 years of age. Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism during screening procedure. Have discontinued gonadotropins, gonadotropin-releasing hormone (GnRH) (gonadotropin naïve), or estrogen progesterone replacement therapy at least one month before the screening procedure. Have a negative progestin challenge test performed during screening. Have the following hormonal values in a centrally analyzed fasting blood sample, drawn within 6 months before initiation of treatment:.

The full record lists 17 inclusion and 11 exclusion criteria; among the exclusions: ongoing pregnancy; any chronic systemic disease; hypersensitive to study drug and control drug.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-02 with completion listed for 2005-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Who Met Both Index 1 and Index 2 (time frame: Day 14). Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter (time frame: Day 14). Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection (time frame: Day 14).

It also tracked 5 secondary outcomes, for example Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle, Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle, Average Change of E2 Level in Participants Per Day up to Day 14, Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies and Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).

What This Means in Plain Language

Put simply, this is a phase 3 trial of hCG (human chorionic gonadotropin) in 31 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.