Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

Weill Cornell Medicine (WCM)

Status and phase

Withdrawn

Phase 2

Conditions

Testosterone Deficiency

Treatments

Drug: Clomiphene Citrate 50mg

Drug: Clomiphene Citrate 25mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05096169

20-10022773

Details and patient eligibility

About

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).

Full description

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). The investigators will perform a pharmacokinetic analysis of serum hormone concentrations (TT, LH, FSH, estradiol) after medication administration. Researchers hypothesize that testosterone levels will increase in both groups and this may allow to dose clomiphene citrate so that patients do not need to take the medication daily.

Sex

Male

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

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