Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

NCT05096169 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 20-10022773
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Testosterone Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in serum testosterone

  Change in serum testosterone

  Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.

Secondary Outcomes (3)

• Change in FSH levels

  Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.

• Change in LH levels

  Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.

• Change in estradiol levels

  Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.

Study Arms (2)

Clomiphene citrate 25 mg daily for 12 weeks

EXPERIMENTAL

Drug: Clomiphene Citrate 25mg

Clomiphene citrate 50 mg every other day for 12 weeks

EXPERIMENTAL

Drug: Clomiphene Citrate 50mg

Interventions

Clomiphene Citrate 25mg DRUG

clomiphene citrate at a dose of 25mg daily

Clomiphene citrate 25 mg daily for 12 weeks

Clomiphene Citrate 50mg DRUG

clomiphene citrate at a dose of 50mg every other day

Clomiphene citrate 50 mg every other day for 12 weeks

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (22)

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• Mulhall JP, Trost LW, Brannigan RE, Kurtz EG, Redmon JB, Chiles KA, Lightner DJ, Miner MM, Murad MH, Nelson CJ, Platz EA, Ramanathan LV, Lewis RW. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol. 2018 Aug;200(2):423-432. doi: 10.1016/j.juro.2018.03.115. Epub 2018 Mar 28.

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• Wheeler KM, Sharma D, Kavoussi PK, Smith RP, Costabile R. Clomiphene Citrate for the Treatment of Hypogonadism. Sex Med Rev. 2019 Apr;7(2):272-276. doi: 10.1016/j.sxmr.2018.10.001. Epub 2018 Dec 3.

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MeSH Terms

Interventions

Clomiphene

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jonathan Gal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individuals will be divided into two groups. Group 1 will receive clomiphene citrate at a dose of 25mg daily and will take one-half of a 50mg tablet daily. Group 2 will receive clomiphene citrate at a dose of 50mg every other day and will take one 50mg tablet every other day.

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 27, 2021
• Study Start: May 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)