Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism

Stopped early · Phase 2

Conditions studied: Hypogonadism, Kallmann Syndrome

In brief

Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small testicular size, low testosterone levels, no history of puberty, and infertility. These men lack a hormone called gonadotropin releasing hormone (GnRH) that stimulates the development and maturation of the testes. This study will investigate the impact of hormonal treatments on men with IHH. The goal of hormonal therapy is to maximize the potential fertility in these individuals.

Key facts

Study ID

NCT00064987

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

19

Starts

2001-04-01

Expected to finish

2012-10-01

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• no history of spontaneous puberty
• clinical hypogonadism
• infantile testes (< 3 ml)
• no reproductive hormone therapy except testosterone
• Complete absence of normal LH pulses during 12-hour baseline frequent blood sampling and serum testosterone < 100 ng/dl
• Normal testing of the anterior pituitary gland
• Negative MRI of the hypothalamic-pituitary area

You may not qualify if…

• Prior therapy with gonadotropins (FSH, hCG, or GnRH)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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