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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00839319
First received: February 6, 2009
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Healthy Males
Drug: Acyline
Other: placebo hCG (no active ingredient)
Drug: hCG (human chorionic gonadotropin)
Drug: Testosterone gel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (Short Title (HOP-3)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Serum Testosterone (T) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Serum Luteinizing Hormone (LH) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Serum Follicle Stimulating Hormone (FSH) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Intratesticular Testosterone (ITT-T) [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: March 2009
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acyline plus Placebo
Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus subcutaneous placebo hCG injection (inj) every other day (5 doses) for 10 days
Drug: Acyline
300 ug/kg subcutaneous injections on Day 1.
Other Name: Acyline GhRH antagonist
Other: placebo hCG (no active ingredient)
placebo hCG
Other Name: placebo drug
Experimental: Acyline plus 15 IU hCG
Acyline 300 ug/kg (SQ) inj(s) on Day 1 plus subcutaneous 15 IU hCG injection (inj) every other day (5 doses) for 10 days
Drug: Acyline
300 ug/kg subcutaneous injections on Day 1.
Other Name: Acyline GhRH antagonist
Drug: hCG (human chorionic gonadotropin)
15 IU subcutaneous injection every other day for 10 days (5 doses)
Other Name: Pregnyl
Experimental: Acyline plus 60 IU hCG
Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus subcutaneous 60 IU hCG injection (inj) every other day (5 doses) for 10 days
Drug: Acyline
300 ug/kg subcutaneous injections on Day 1.
Other Name: Acyline GhRH antagonist
Drug: hCG (human chorionic gonadotropin)
60 IU subcutaneous injection
Other Name: Pregnyl
Experimental: Acyline plus 125 IU hCG
Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus subcutaneous 125 IU hCG injection (inj) every other day (5 doses) for 10 days
Drug: Acyline
300 ug/kg subcutaneous injections on Day 1.
Other Name: Acyline GhRH antagonist
Drug: hCG (human chorionic gonadotropin)
125 IU subcutaneous injection
Other Name: Pregnyl
Experimental: Acyline plus Testosterone gel
Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus Testosterone gel 75 mg/day daily for 10 days
Drug: Acyline
300 ug/kg subcutaneous injections on Day 1.
Other Name: Acyline GhRH antagonist
Drug: Testosterone gel
75 mg testosterone gel applied transdermally for 10 days
Other Name: Testim

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839319

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: William Bremner, MD, PhD University of Washington
  More Information

Additional Information:
Publications:

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00839319     History of Changes
Other Study ID Numbers: 27158-D, U54HD012629
Study First Received: February 6, 2009
Results First Received: October 15, 2010
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
hCG
testosterone
Acyline
Intratesticular hormone

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Chorionic Gonadotropin
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 17, 2014