Why Are Testosterone Patches for Women Not Approved?
In 2004, Proctor & Gamble applied for FDA approval of its transdermal testosterone system (a testosterone patch), Intrinsa. Intrinsa was intended to treat hypoactive sexual desire disorder (HSDD) in surgically menopausal women who were receiving estrogen therapy. HSDD is a type of sexual dysfunction linked to a lack of sexual desire.
Results from P&G’s Phase 3 clinical trials suggest that in women with two to three sexually rewarding events per month, administration of 300 µg of transdermal testosterone daily was linked to one additional sexually satisfying event per month. However, neither 150 µg nor 450 µg had any significant impact on the frequency of sexually satisfying events.
The FDA refused to approve the drug because it deemed the trial results of little clinical value. The FDA also expressed concerns that women who had undergone hysterectomies (who as a result, experienced surgically-induced menopause), and were already taking estrogen would also be exposed to testosterone—a hormone that’s potentially unsafe for women.
Even with testosterone gels and patches that have been approved to treat men, there is still a lack of data on how much testosterone actually gets absorbed. That, combined with its known side effects, makes testosterone supplementation more concerning. Long-term testosterone supplementation increases a man’s risk of cardiovascular problems like stroke, heart attack, and fatal heart disease. Some medical professionals are also concerned that testosterone supplementation could stimulate the growth of prostate cancer cells.
Other Therapies for Female Sexual Dysfunction
In place of the patch, there are two drugs approved for the treatment of HSDD in women. The first is Addyi (flibanserin), a non-hormonal pink tablet indicated for use by premenopausal women. The other is Vyleesi (bremelanotide), an injectable drug used to treat acquired HSDD in women who haven’t reached menopause yet.
Although unapproved, Viagra has also been investigated for use in treating female sexual dysfunction and it is sometimes prescribed off-label.
If female sexual dysfunction (FDS) is caused by or related to an underlying medical condition, the management and treatment of the condition should be examined and optimized. For instance, medical conditions like diabetes and multiple sclerosis have been known to contribute to female sexual dysfunction. Further, some of the medications used to treat conditions like hypertension have side effects that negatively impact arousal. If after investigation, your healthcare provider finds that a particular medication is the cause of your FSD, the dosage of the offending drug can be adjusted.
Finally, to treat sexual dysfunction caused by antidepressants (SSRIs in particular), central nervous system medications may be prescribed. Studies have shown that high doses of bupropion (150 mg twice daily) have shown promise in treating SSRI-related sexual dysfunction in women.
A Word From Verywell
While you can get access to testosterone (through off-label prescriptions and online supplements), using testosterone therapy should only be considered after having an appropriate evaluation and full consent discussion of possible risks and benefits with your doctor. Testosterone is a hormone, and hormones have been known to have potential adverse effects like stroke, blood clots, cancer and so forth. Pursuing other treatment options, like seeing a therapist, maybe more beneficial for you in the long run. Practicing mindfulness—which focuses on the awareness of the present moment—may also help.
