World J Mens Health.  2020 Apr;38(2):220-225. 10.5534/wjmh.190028.

Demographics, Usage Patterns, and Safety of Male Users of Clomiphene in the United States

  • 1Department of Urology, Stanford University School of Medicine, Stanford, CA, USA.
  • 2Department of Health Research and Policy, Stanford University, Stanford, CA, USA.
  • 3Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, CA, USA.


The aim of this study was to characterize the demographics, usage patterns and complication rates of clomiphene use in male patients.
We retrospectively analyzed male patients from ages 20 to 55 years old who were prescribed clomiphene citrate from 2001 to 2014 using the Truven Health MarketScan, a US claims database. We collected data regarding associated medical diagnoses, diagnostic testing, duration of use, and reported side effects including thrombotic events, vision problems, gynecomastia, mental disorders, liver disease, nausea, or skin problems.
In total, 12,318 men took clomiphene and represented the primary study cohort, with a mean age of 37.8 years. The percentage of men prescribed clomiphene increased over the study period, as did the average age of clomiphene users. Associated diagnoses included male infertility (52.0%), testicular hypofunction (13.5%), erectile dysfunction (2.4%), and low libido (0.4%). Associated testing included semen analysis (43.7%), testosterone (23.5%), luteinizing hormone (19.3%), and follicle-stimulating hormone (21.1%) levels. The median time of clomiphene use was 3.6 months, with 63% of men stopping within 6 months. No increased risk of reported clomiphene side effects were apparent in men taking the medication.
There is a rising prevalence of clomiphene usage without associated adverse side effects in the US. The variability in associated diagnoses, diagnostic testing, and duration of use suggest a need for greater awareness of the proper evaluation and treatment of the men who are prescribed clomiphene.


Clomiphene; Demography; Infertility, male; Safety

MeSH Terms

Cohort Studies
Diagnostic Tests, Routine
Erectile Dysfunction
Follicle Stimulating Hormone
Infertility, Male
Liver Diseases
Luteinizing Hormone
Mental Disorders
Retrospective Studies
Semen Analysis
United States*
Follicle Stimulating Hormone
Luteinizing Hormone


1. Sabanegh E, Agarwal A. Male infertility. In : Wein A, Kavoussi L, Novick A, Partin A, Peters CA, editors. Campbell-Walsh urology. 9th ed. Philadelphia: Saunders Elsevier;2007.
2. Paulson DF, Wacksman J. Clomiphene citrate in the management of male infertility. J Urol. 1976; 115:73–76. PMID: 1246117.
3. Roth LW, Ryan AR, Meacham RB. Clomiphene citrate in the management of male infertility. Semin Reprod Med. 2013; 31:245–250. PMID: 23775379.
4. Practice Committee of the American Society for Reproductive Medicine. Use of clomiphene citrate in infertile women: a committee opinion. Fertil Steril. 2013; 100:341–348. PMID: 23809505.
5. World Health Organization: Special Programme of Research, Development and Research Training in Human Reproduction. Task Force on the Prevention and Management of Infertility. A double-blind trial of clomiphene citrate for the treatment of idiopathic male infertility. World Health Organization. Int J Androl. 1992; 15:299–307. PMID: 1516979.
6. Ghanem H, Shaeer O, El-Segini A. Combination clomiphene citrate and antioxidant therapy for idiopathic male infertility: a randomized controlled trial. Fertil Steril. 2010; 93:2232–2235. PMID: 19268928.
7. Chua ME, Escusa KG, Luna S, Tapia LC, Dofitas B, Morales M. Revisiting oestrogen antagonists (clomiphene or tamoxifen) as medical empiric therapy for idiopathic male infertility: a meta-analysis. Andrology. 2013; 1:749–757. PMID: 23970453.
8. Ko EY, Siddiqi K, Brannigan RE, Sabanegh ES Jr. Empirical medical therapy for idiopathic male infertility: a survey of the American Urological Association. J Urol. 2012; 187:973–978. PMID: 22264467.
9. Khandwala YS, Zhang CA, Lu Y, Eisenberg ML. The age of fathers in the USA is rising: an analysis of 168 867 480 births from 1972 to 2015. Hum Reprod. 2017; 32:2110–2116. PMID: 28938735.
10. Levine H, Jørgensen N, Martino-Andrade A, Mendiola J, Weksler-Derri D, Mindlis I, et al. Temporal trends in sperm count: a systematic review and meta-regression analysis. Hum Reprod Update. 2017; 23:646–659. PMID: 28981654.
11. Lo EM, Rodriguez KM, Pastuszak AW, Khera M. Alternatives to testosterone therapy: a review. Sex Med Rev. 2018; 6:106–113. PMID: 29174957.
12. 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; 110:1524–1528. PMID: 22458540.
13. 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; 192:875–879. PMID: 24657837.
14. Jarow JP, Sharlip ID, Belker AM, Lipshultz LI, Sigman M, Thomas AJ, et al. Male Infertility Best Practice Policy Committee of the American Urological Association Inc. Best practice policies for male infertility. J Urol. 2002; 167:2138–2144. PMID: 11956464.
15. Ross LS, Kandel GL, Prinz LM, Auletta F. Clomiphene treatment of the idiopathic hypofertile male: high-dose, alternate-day therapy. Fertil Steril. 1980; 33:618–623. PMID: 6769716.
16. Dupree JM. Insurance coverage for male infertility care in the United States. Asian J Androl. 2016; 18:339–341. PMID: 27030084.
17. Dupree JM, Dickey RM, Lipshultz LI. Inequity between male and female coverage in state infertility laws. Fertil Steril. 2016; 105:1519–1522. PMID: 26953734.
Full Text Links
  • WJMH
export Copy
  • Twitter
  • Facebook
Similar articles
Copyright © 2023 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: