HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone
Condition: Healthy Males
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      Three study drugs will be used in this study: Testim (testosterone gel), Human Chorionic
      Gonadotropin (hCG) and acyline. Testosterone is a naturally occurring hormone in men. When
      given to normal men, testosterone gel will temporarily lower the amount of testosterone in
      the testes and lower sperm counts. hCG is a female hormone produced during pregnancy that is
      similar to and has the same actions as a male hormone, luteinizing hormone (LH). Like LH, hCG
      stimulates the testis to produce testosterone and sperm, and is used in the treatment of men
      who are deficient in LH. When hCG is given together with testosterone to normal men, the
      amount of testosterone in the testes will change, dependent on the amount of hCG received.
      Some participants will receive placebo hCG injections (no active medication).

      Acyline suppresses LH (luteinizing hormone) and FSH (follicle stimulating hormone), which are
      hormones made by the pituitary gland in the brain, thus blocking the signal from the brain
      that causes the testes to make testosterone. Therefore, acyline blocks testosterone
      production. Men may experience some side effects from the low levels of testosterone caused
      by acyline.

      Acyline is an experimental drug. Testosterone gel and hCG are approved for use in men with
      low testosterone levels. The U.S. Food and Drug Administration (FDA) allows testosterone gel,
      hCG and acyline to be given in combination for research to a small number of volunteers. Over
      125 men have received acyline. Both Acyline and hCG will be given by injection. Acyline
      injections are formulated by subjects weight and may be given in multiple injections.

      Participation will last approximately 2 months. The study involves a minimum of 9 visits in
      Seattle, WA. Clinic visits at Screening, Day 1 and Day 10 will take about 1-1.5 hours each.
      On Day 1 & 10 a fine needle aspiration of one testis will be performed. The Day 7, Day 17,
      and Day 40 visits will take approximately 30 minutes. The other visits will take about 15
      minutes each time. Over the course of the study, which includes 5 separate blood draws,
      approximately 12 ounces (one and a half cups) of blood will be drawn. Some of the study drugs
      will be given by injection. One drug is a topical gel.

      This is NOT a trial of a male contraceptive, and the study medications will not prevent
      pregnancy. Subjects must use an acceptable form of birth control.
    

Intervention name(s): Acyline; placebo hCG (no active ingredient); hCG (human chorionic gonadotropin); hCG (human chorionic gonadotropin); hCG (human chorionic gonadotropin); Testosterone gel
Intervention type(s): Drug; Other; Drug; Drug; Drug; Drug
Intervention description(s): 300 ug/kg subcutaneous injections on Day 1.; placebo hCG; 15 IU subcutaneous injection every other day for 10 days (5 doses); 60 IU subcutaneous injection; 125 IU subcutaneous injection; 75 mg testosterone gel applied transdermally for 10 days
Other intervention name(s): Acyline GhRH antagonist; placebo drug; Pregnyl; Pregnyl; Pregnyl; Testim
Intervention MeSH terms: Chorionic Gonadotropin; Testosterone; Acyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hCG; testosterone; Acyline; Intratesticular hormone