Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphen… (NCT05096169) | Clinical Trial Compass
WithdrawnPhase 2
Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate
Stopped: Difficulty in recruiting
United States0Started 2022-05-01
Plain-language 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).
Who can participate
Age range21 Years – 45 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 suffici…
What they're measuring
1
Change in serum testosterone
Timeframe: Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.
Trial details
NCT IDNCT05096169
SponsorWeill Medical College of Cornell University