HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this investigational study is to determine how much male hormone, testosterone, is necessary to maintain sperm production in the testis. This knowledge will be used to help in the development of a safe male hormonal contraception.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Acyline; Chorionic Gonadotropin; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Males age 18-50

• Normal serum testosterone, LH and FSH

• PSA < 4.0

• Agrees not to donate blood or participate in another research study during the study

• Informed consent

• In general good health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry and hematology)

• Must be willing to use a reliable form of contraception during the study

Exclusion Criteria:

• Oligospermia (sperm count < 15 million/mL after 48 hours of abstinence) and/or abnormal motility or morphology.

• Participation in a long-term male contraceptive study within the past three months

• History of testosterone or anabolic steroid abuse in the past

• Poor general health with significantly abnormal blood results

• History of or current testicular disease

• History of a bleeding disorder or need for anticoagulation

• History of sleep apnea and/or major psychiatric problems

• BMI > 32

• Subjects with a skin condition that might interfere or be exacerbated by testosterone gel use

• Subject's with alcohol or drug use