ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this research 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.

Specific Aims:

1. to determine if ketoconazole plus acyline will suppress intratesticular testosterone(ITT) to a greater degree than acyline alone.

2. to determine if dutasteride plus acyline will suppress intratesticular dihydrotestosterone (IT-DHT) to a greater degree than acyline alone.

3. to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2) to a greater degree than acyline alone.

• 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; Anastrozole; Dutasteride; Ketoconazole; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

INCLUSION CRITERIA:

• Males age 18-50

• Normal serum testosterone, LH and FSH

• prostate-specific antigen (PSA) < 4.0

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

• Informed consent

• Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

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

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

EXCLUSION CRITERIA:

• Poor general health, with clinically significant abnormal blood results

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

• Participation in long-term contraceptive or drug study within the past 3 months

• History of or current liver disease

• Current use of terfenadine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil

• History of testicular, prostate, or scrotal surgery/trauma or genital abnormal exam

• BMI > 32

• History of sleep apnea and/or major psychiatric problems

• Chronic pain syndrome

• History of testosterone or anabolic steroid abuse currently or in the past

• Known bleeding disorder or current use of anticoagulation

• History of or current skin disorder that will interfere with testosterone gel

• Unwilling to adhere to protocol-stated restrictions while in the study