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

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Follicle Stimulating Hormone; Hormones

Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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