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Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05096169
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
19
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Clomiphene Citrate 25mg
  • Drug: Clomiphene Citrate 50mg
 Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Other
Official Title:
Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clomiphene citrate 25 mg daily for 12 weeks

Drug: Clomiphene Citrate 25mg
clomiphene citrate at a dose of 25mg daily
Experimental: Clomiphene citrate 50 mg every other day for 12 weeks

Drug: Clomiphene Citrate 50mg
clomiphene citrate at a dose of 50mg every other day

Outcome Measures

Primary Outcome Measures

  1. Change in serum testosterone [Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.]

    Change in serum testosterone

Secondary Outcome Measures

  1. Change in FSH levels [Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.]

    Serum levels of follicle-stimulating hormone (FSH)

  2. Change in LH levels [Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.]

    Serum levels of luteinizing hormone (LH)

  3. Change in estradiol levels [Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.]

    Serum levels of estradiol levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medicine New York New York United States 10065

Sponsors and Collaborators

  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Caroline Kang, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT05096169
Other Study ID Numbers:
  • 20-10022773
First Posted:
Oct 27, 2021
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene

Study Results

No Results Posted as of May 20, 2022