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

December 9, 2015 updated by: John Amory, University of Washington

Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (Short Title (HOP-3)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Acyline GhRH antagonist
Other: placebo hCG (no active ingredient)
placebo hCG
Other Names:
  • 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 Names:
  • Acyline GhRH antagonist
Drug: hCG (human chorionic gonadotropin)
15 IU subcutaneous injection every other day for 10 days (5 doses)
Other Names:
  • Pregnyl
Drug: hCG (human chorionic gonadotropin)
60 IU subcutaneous injection
Other Names:
  • Pregnyl
Drug: hCG (human chorionic gonadotropin)
125 IU subcutaneous injection
Other Names:
  • 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 Names:
  • Acyline GhRH antagonist
Drug: hCG (human chorionic gonadotropin)
15 IU subcutaneous injection every other day for 10 days (5 doses)
Other Names:
  • Pregnyl
Drug: hCG (human chorionic gonadotropin)
60 IU subcutaneous injection
Other Names:
  • Pregnyl
Drug: hCG (human chorionic gonadotropin)
125 IU subcutaneous injection
Other Names:
  • 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 Names:
  • Acyline GhRH antagonist
Drug: hCG (human chorionic gonadotropin)
15 IU subcutaneous injection every other day for 10 days (5 doses)
Other Names:
  • Pregnyl
Drug: hCG (human chorionic gonadotropin)
60 IU subcutaneous injection
Other Names:
  • Pregnyl
Drug: hCG (human chorionic gonadotropin)
125 IU subcutaneous injection
Other Names:
  • 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 Names:
  • Acyline GhRH antagonist
Drug: Testosterone gel
75 mg testosterone gel applied transdermally for 10 days
Other Names:
  • Testim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Testosterone (T)
Time Frame: 10 days
10 days
Serum Luteinizing Hormone (LH)
Time Frame: 10 days
10 days
Serum Follicle Stimulating Hormone (FSH)
Time Frame: 10 days
10 days
Intratesticular Testosterone (ITT-T)
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Investigators

  • Principal Investigator: William Bremner, MD, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 9, 2009

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27158-D
  • U54HD012629 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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