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Testosterone DeficiencyPhase 2NCT05096169

Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

A Phase 2 study testing Clomiphene Citrate 25mg and Clomiphene Citrate 50mg in people with Testosterone Deficiency, run by Weill Medical College of Cornell University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Testosterone Deficiency
What is being tested?
Clomiphene Citrate 25mg and Clomiphene Citrate 50mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 May 2022to Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

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).

Read the 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.

Being tested
Clomiphene Citrate 25mg, Clomiphene Citrate 50mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clomiphene Citrate 25mgDrug

    clomiphene citrate at a dose of 25mg daily

  • Clomiphene Citrate 50mgDrug

    clomiphene citrate at a dose of 50mg every other day

Study groups in NCT05096169
Study groupRoleWhat they receive
Clomiphene citrate 25 mg daily for 12 weeksExperimentalNot described
Receives: Drug: Clomiphene Citrate 25mg
Clomiphene citrate 50 mg every other day for 12 weeksExperimentalNot described
Receives: Drug: Clomiphene Citrate 50mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum testosterone

    Change in serum testosterone

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

Secondary outcomes (3)

  1. Change in FSH levels

    Serum levels of follicle-stimulating hormone (FSH)

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

  2. Change in LH levels

    Serum levels of luteinizing hormone (LH)

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

  3. Change in estradiol levels

    Serum levels of estradiol levels

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start1 May 2022 (estimated)
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (estimated)

Why it stopped: Difficulty in recruiting

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096169
Sponsor's protocol ID
20-10022773
Status last verified
Oct 2024
First submitted
18 Oct 2021
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul;60(7):762-9. doi: 10.1111/j.1742-1241.2006.00992.x.

    PubMed 16846397

  • 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.

    PubMed 29601923

  • 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.

    PubMed 30522888

  • Mazzola CR, Katz DJ, Loghmanieh N, Nelson CJ, Mulhall JP. Predicting biochemical response to clomiphene citrate in men with hypogonadism. J Sex Med. 2014 Sep;11(9):2302-7. doi: 10.1111/jsm.12592. Epub 2014 Jun 5.

    PubMed 24902614

  • Moskovic DJ, Katz DJ, Akhavan A, Park K, Mulhall JP. Clomiphene citrate is safe and effective for long-term management of hypogonadism. BJU Int. 2012 Nov;110(10):1524-8. doi: 10.1111/j.1464-410X.2012.10968.x. Epub 2012 Mar 28.

    PubMed 22458540

  • Katz DJ, Nabulsi O, Tal R, Mulhall JP. Outcomes of clomiphene citrate treatment in young hypogonadal men. BJU Int. 2012 Aug;110(4):573-8. doi: 10.1111/j.1464-410X.2011.10702.x. Epub 2011 Nov 1.

    PubMed 22044663

  • Tenover JS, Bremner WJ. The effects of normal aging on the response of the pituitary-gonadal axis to chronic clomiphene administration in men. J Androl. 1991 Jul-Aug;12(4):258-63.

    PubMed 1917692

  • Bendre SV, Murray PJ, Basaria S. Clomiphene Citrate Effectively Increases Testosterone in Obese, Young, Hypogonadal Men. Reprod Syst Sex Disord. 2015 Dec;4(4):155. doi: 10.4172/2161-038X.1000155. Epub 2015 Nov 13.

    PubMed 26844009

  • Habous M, Giona S, Tealab A, Aziz M, Williamson B, Nassar M, Abdelrahman Z, Remeah A, Abdelkader M, Binsaleh S, Muir G. Clomiphene citrate and human chorionic gonadotropin are both effective in restoring testosterone in hypogonadism: a short-course randomized study. BJU Int. 2018 Nov;122(5):889-897. doi: 10.1111/bju.14401. Epub 2018 Jun 14.

    PubMed 29772111

  • Ramasamy R, Scovell JM, Kovac JR, Lipshultz LI. Testosterone supplementation versus clomiphene citrate for hypogonadism: an age matched comparison of satisfaction and efficacy. J Urol. 2014 Sep;192(3):875-9. doi: 10.1016/j.juro.2014.03.089. Epub 2014 Mar 21.

    PubMed 24657837

  • Krzastek SC, Sharma D, Abdullah N, Sultan M, Machen GL, Wenzel JL, Ells A, Chen X, Kavoussi M, Costabile RA, Smith RP, Kavoussi PK. Long-Term Safety and Efficacy of Clomiphene Citrate for the Treatment of Hypogonadism. J Urol. 2019 Nov;202(5):1029-1035. doi: 10.1097/JU.0000000000000396. Epub 2019 Oct 9.

    PubMed 31216250

  • Knight JC, Pandit AS, Rich AM, Trevisani GT, Rabinowitz T. Clomiphene-Associated Suicide Behavior in a Man Treated for Hypogonadism: Case Report and Review of The Literature. Psychosomatics. 2015 Sep-Oct;56(5):598-602. doi: 10.1016/j.psym.2015.06.003. Epub 2015 Jun 12. No abstract available.

    PubMed 26362915

  • Pasqualotto FF, Fonseca GP, Pasqualotto EB. Azoospermia after treatment with clomiphene citrate in patients with oligospermia. Fertil Steril. 2008 Nov;90(5):2014.e11-2. doi: 10.1016/j.fertnstert.2008.03.036. Epub 2008 Jun 16.

    PubMed 18555230

  • Ernst S, Hite G, Cantrell JS, Richardson A Jr, Benson HD. Stereochemistry of geometric isomers of clomiphene: a correction of the literature and a reexamination of structure-activity relationships. J Pharm Sci. 1976 Jan;65(1):148-50. doi: 10.1002/jps.2600650140. No abstract available.

    PubMed 1255423

  • Murdter TE, Kerb R, Turpeinen M, Schroth W, Ganchev B, Bohmer GM, Igel S, Schaeffeler E, Zanger U, Brauch H, Schwab M. Genetic polymorphism of cytochrome P450 2D6 determines oestrogen receptor activity of the major infertility drug clomiphene via its active metabolites. Hum Mol Genet. 2012 Mar 1;21(5):1145-54. doi: 10.1093/hmg/ddr543. Epub 2011 Nov 22.

    PubMed 22108178

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clomiphene Citrate 25mg and Clomiphene Citrate 50mg in people with Testosterone Deficiency, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum testosterone (time frame: Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096169, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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