From the Guidelines
No, Clomid (clomiphene citrate) is not FDA approved for treating erectile dysfunction or low libido in men. According to the American Urological Association (AUA) guideline on erectile dysfunction, published in 2018 1, the FDA-approved oral phosphodiesterase type 5 inhibitors (PDE5i) for the management of ED in the U.S. include sildenafil, tadalafil, vardenafil, and avanafil. These medications have been extensively studied and have shown similar efficacy in the general ED population.
- The AUA guideline recommends that men with ED be informed about the treatment option of an FDA-approved oral PDE5i, including discussion of benefits and risks/burdens, unless contraindicated 1.
- The guideline also recommends that the dose of PDE5i be titrated to provide optimal efficacy 1.
- Clomid, on the other hand, is FDA approved for the treatment of ovulatory dysfunction in women who wish to become pregnant, and is sometimes prescribed off-label to treat male infertility or hypogonadism (low testosterone) in men.
- While Clomid may increase testosterone production in men, which can lead to improvements in libido, it is not specifically indicated for erectile dysfunction, and its use for this purpose is not supported by the AUA guideline 1.
- Men experiencing erectile dysfunction or low libido should consult with a healthcare provider to discuss appropriate FDA-approved treatment options, such as sildenafil, tadalafil, or vardenafil, which have been shown to be effective and safe in the treatment of ED 1.
From the FDA Drug Label
Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility.
Clomid is not FDA approved for erectile dysfunction and low libido in men. The FDA label does not provide any information that supports the use of clomiphene citrate for the treatment of erectile dysfunction and low libido in men 2.
From the Research
Clomid FDA Approval for Erectile Dysfunction and Low Libido in Men
- Clomid, also known as clomiphene citrate, is not typically approved by the FDA for the treatment of erectile dysfunction and low libido in men 3, 4, 5, 6, 7.
- However, it is used off-label for the treatment of hypogonadism in men, which can lead to improved testosterone levels and potentially alleviate symptoms of erectile dysfunction and low libido 3, 4, 5, 6, 7.
- Studies have shown that clomiphene citrate can increase testosterone levels, improve erectile function, and enhance overall sexual function in men with hypogonadism 3, 4, 5, 6, 7.
- The FDA has not specifically approved clomiphene citrate for the treatment of erectile dysfunction and low libido in men, but it has been used as an off-label treatment for these conditions 3, 4, 5, 6, 7.
Efficacy and Safety of Clomiphene Citrate
- Clomiphene citrate has been shown to be effective in increasing testosterone levels and improving symptoms of hypogonadism in men 3, 4, 5, 6, 7.
- The safety profile of clomiphene citrate is generally considered to be good, with few reported side effects and no serious adverse events 3, 4, 5, 6, 7.
- However, clomiphene citrate can cause increased estradiol levels, which may lead to side effects such as gynecomastia and mood changes 3, 4, 5, 6, 7.
Off-Label Use of Clomiphene Citrate
- Clomiphene citrate is not typically offered as a primary treatment for hypogonadism in men who do not desire fertility preservation 4.
- However, it may be used off-label for the treatment of erectile dysfunction and low libido in men, particularly those with hypogonadism 3, 4, 5, 6, 7.
- The use of clomiphene citrate for these conditions should be carefully considered and monitored by a healthcare professional 3, 4, 5, 6, 7.