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Long-Term Use Of Enclomiphene: Safety, Side Effects, And Monitoring

02/14/2024 | by

Enclomiphene’s long-term safety remains uncertain due to limited research. While it may have fewer side effects than testosterone replacement therapy (TRT) and preserve fertility, potential side effects include mood changes and increased estradiol. Further studies are needed to fully understand its long-term impact.

NOTE: Enclomiphene is not currently approved by the FDA. While it is a purified isomer of clomiphene (which is FDA approved), it has not yet received approval for any specific indication. There has been research and clinical trials exploring the potential of enclomiphene, particularly in the treatment of hypogonadism in men, which will be explored in detail below. However, the FDA has not yet reviewed and approved any new drug applications for this drug. Please note that it’s always important to consult with a healthcare professional for the most up-to-date and accurate information about any medication, including enclomiphene.

  • Food and Drug Administration (FDA). (2022, June 8). Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting. [Website]. https://www.fda.gov/media/161293/download

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Safety of Long-Term Enclomiphene Use

Enclomiphene is a compound currently being researched as a therapy to treat hypogonadism (low testosterone) in men. It presents an alternative to testosterone replacement therapy (TRT), potentially avoiding some of TRT’s drawbacks, such as reduced fertility/sperm production and exacerbation of certain pre-existing conditions like congestive heart failure and sleep apnea.

While enclomiphene may offer a more favorable safety profile compared to TRT in certain aspects, it’s important to note that it’s not entirely free of side effects. Some potential side effects include mood swings, vision changes, and increased estradiol levels.

Current research on the long-term use of enclomiphene is limited. Most projections about its long-term effects are based on studies of a related drug, clomiphene citrate. While these studies can offer valuable insights, it’s important to remember that enclomiphene may have distinct characteristics and long-term effects that warrant and require further investigation.

CLARIFICATION: Clomiphene citrate is approved by the FDA for the treatment of ovulatory dysfunction in women who are trying to become pregnant. It is important to note that clomiphene citrate is not approved for use in men.

  • Krzastek, S. C., Sharma, D., Abdullah, N., Sultan, M., Machen, G. L., Wenzel, J. L., Ells, A., Chen, X., Kavoussi, M., Costabile, R. A., Smith, R. P., & Kavoussi, P. K. (2019). Long-Term Safety and Efficacy of Clomiphene Citrate for the Treatment of Hypogonadism. The Journal of urology, 202(5), 1029–1035. https://doi.org/10.1097/JU.0000000000000396
  • Ramasamy, R., Scovell, J. M., Kovac, J. R., & Lipshultz, L. I. (2014). Testosterone Supplementation Versus Clomiphene Citrate for Hypogonadism: An Age Matched Comparison of Satisfaction and Efficacy. Journal of Urology, 192(3), 875–879. https://doi.org/10.1016/j.juro.2014.03.089
  • Rodriguez, K. M., Pastuszak, A. W., & Lipshultz, L. I. (2016). Enclomiphene citrate for the treatment of secondary male hypogonadism. Expert opinion on pharmacotherapy, 17(11), 1561–1567. https://doi.org/10.1080/14656566.2016.1204294

Side Effects of Long-Term Enclomiphene Use

A 2016 review in Expert Opinion on Pharmacotherapy highlighted the emerging use of enclomiphene for secondary male hypogonadism, noting its favourable tolerability profile compared to testosterone replacement therapy (TRT). The authors emphasized the need for direct comparison studies between enclomiphene and clomiphene to determine their relative efficacy.

A 2019 study in the Journal of Urology investigated the long-term use of clomiphene citrate in 400 men with hypogonadism. The study found that 88% of the men treated for over three years achieved normal testosterone levels, with 77% reporting symptom improvement. Side effects were observed in only 8% of these patients. Importantly, no significant differences in outcomes were found between patients treated for more than three years and those treated for three years or less.

While these findings suggest that clomiphene citrate may be a safe and effective long-term treatment option for male hypogonadism, the absence of a control group in the study design warrants cautious interpretation. Further research, including controlled trials, is necessary to definitively establish the long-term safety and efficacy of clomiphene citrate in this context. While this study offers valuable insights into clomiphene citrate, it’s important to remember that enclomiphene, though structurally similar, may not demonstrate the same results. Further research is needed to directly investigate the effects of enclomiphene.

  • Krzastek, S. C., Sharma, D., Abdullah, N., Sultan, M., Machen, G. L., Wenzel, J. L., Ells, A., Chen, X., Kavoussi, M., Costabile, R. A., Smith, R. P., & Kavoussi, P. K. (2019). Long-Term Safety and Efficacy of Clomiphene Citrate for the Treatment of Hypogonadism. The Journal of urology, 202(5), 1029–1035. https://doi.org/10.1097/JU.0000000000000396
  • Rodriguez, K. M., Pastuszak, A. W., & Lipshultz, L. I. (2016). Enclomiphene citrate for the treatment of secondary male hypogonadism. Expert opinion on pharmacotherapy, 17(11), 1561–1567. https://doi.org/10.1080/14656566.2016.1204294

Side Effects of Long-Term Enclomiphene Use

While long-term data on enclomiphene is still emerging, studies conducted using clomiphene for up to three years have provided insights into potential side effects. Due to the structural similarities between enclomiphene and clomiphene, healthcare professionals often reference the side effects of clomiphene when assessing the potential risks of enclomiphene. However, caution must be taken when extrapolating data from clomiphene to enclomiphene, as their structural differences may lead to variations in effects.

Known side effects of enclomiphene may include:

  • Increased libido
  • Acne
  • Dizziness and headaches
  • Mood changes (e.g., irritability, aggression)
  • Hot flashes and night sweats
  • Fatigue
  • Breast tenderness or gynecomastia (due to elevated estradiol)

NOTE: It is crucial to inform your doctor of any side effects experienced while taking enclomiphene. While generally well-tolerated, the severity of side effects can vary, and prompt reporting allows for personalized management and potential adjustment of treatment.

Enclomiphene may not be suitable for everyone. A thorough medical evaluation, considering your overall health, current medications, and medical history, is essential to determine if enclomiphene is the safest and most effective option for you. Individuals with a history of cardiovascular disease, pituitary adenoma, liver disease, or certain types of cancer may not be candidates for enclomiphene.

  • Ramasamy, R., Scovell, J. M., Kovac, J. R., & Lipshultz, L. I. (2014). Testosterone Supplementation Versus Clomiphene Citrate for Hypogonadism: An Age Matched Comparison of Satisfaction and Efficacy. Journal of Urology, 192(3), 875–879. https://doi.org/10.1016/j.juro.2014.03.089
  • Rodriguez, K. M., Pastuszak, A. W., & Lipshultz, L. I. (2016). Enclomiphene citrate for the treatment of secondary male hypogonadism. Expert opinion on pharmacotherapy, 17(11), 1561–1567. https://doi.org/10.1080/14656566.2016.1204294

Monitoring of Long-Term Enclomiphene Use

While clinical trials have demonstrated the short-term safety and efficacy of enclomiphene, long-term data is still emerging and warrants further investigation.

Conclusion

Enclomiphene is a compound currently being investigated for the treatment of hypogonadism (low testosterone) in men by stimulating the body’s natural testosterone production. Compared to testosterone replacement therapy (TRT), enclomiphene is generally thought to be associated with fewer side effects and appears not to suppress sperm production or fertility.

While short-term studies have shown promising results, more research is needed to evaluate the long-term safety and efficacy of enclomiphene.

NOTE: The FDA has concluded that there is currently insufficient evidence to support the effectiveness of enclomiphene citrate for treating hypogonadism in men. While studies suggest it may increase testosterone levels, along with LH and FSH, it remains unclear whether this translates to clinical effectiveness or benefit in men with secondary hypogonadism. Current clinical trials have not demonstrated clinically meaningful improvement in symptoms or signs of this condition, and there are already FDA-approved therapies with established efficacy for this purpose.

The FDA also notes that despite being studied for decades, primarily for ovulation induction and secondary hypogonadism, enclomiphene citrate has been advertised by clinics and compounding pharmacies in the U.S. without sufficient information on the extent of its use domestically or internationally. It is not recognized in European or Japanese pharmacopoeias. As such, the FDA has not yet reviewed and approved any new drug applications for enclomiphene and currently enclomiphene has not yet received approval for any specific indication.

  • Food and Drug Administration (FDA). (2022, June 8). FDA Briefing Document: Pharmacy Compounding Advisory Committee (PCAC) Meeting. [Website]. https://www.fda.gov/media/158541/download

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