Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) < 300 ng/dl).

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

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Sodium Citrate; Zuclomiphene

Criteria

Inclusion Criteria:

• Male, 21-45 years of age

• Serum testosterone concentration < 300 ng/dl measured on two separate occasions (separated by at least one week), with collection prior to 10AM

Exclusion Criteria:

• Serum testosterone concentration > 300 ng/dl

• Abnormal serum prolactin (PRL) concentration (PRL > 15.2 ng/ml)

• Concurrent or prior use of hormone-modifying medications (clomiphene citrate or other SERM, testosterone replacement therapy or other testosterone-containing products/treatments, gonadotropin therapy, aromatase inhibitors, estrogen-containing products/treatments)

• Documented karyotype abnormality

• Diagnosis of Kallmann syndrome

• Any prior chemotherapy, radiation therapy to the groin/pelvis, or known exposure to gonadotoxic agents

• History of cryptorchidism or prior orchiopexy

• History of testicular cancer or prior orchiectomy

• History of pituitary tumor or resection of pituitary tumor

• History of prostate cancer or severe benign prostatic hypertrophy

• History of epididymitis or epididymo-orchitis, or orchitis (including mumps)

• History of primary hypogonadism

• History of prior urinary tract infection

• History of intravenous drug use

• Any of the following comorbidities: renal insufficiency, heart disease, peptic ulcer disease, cerebrovascular disease, liver disease, psychiatric disorders, chronic pain, bleeding diatheses, anemia, polycythemia, vision problems

• Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject

• Documented allergy or hypersensitivity to clomiphene citrate or other SERM