Testosterone Nasal Gel – What Should You Know About It?
The synthetic formulations of testosterone can be delivered via a number of mechanisms; one of which is intranasal route and use of nasal gel. The ideal candidates for testosterone gel are; hypogonadal men with sub-normal levels of testosterone who are also experiencing symptoms such as poor libido, low sex drive, erectile dysfunction, poor muscle mass, excessive and unexplained fatigue, etc.
Are There Any Benefits Of Testosterone Nasal Gels?
There are several benefits of consuming testosterone via nasal route; such as:
- Higher bioavailability of hormone: Nostrils are richly supplied with a vast network of thin capillaries which allows rapid absorption of hormone directly into the blood stream (hence bypassing the liver circulation and gastrointestinal degradation of hormone).
- Convenience: Unlike muscular injections, intranasal route is rather pain-free and more convenient for everyday use. Also men can self-administer the hormone in the comforts of home, which saves the healthcare costs and time spent in making the appointments.
- Minimal risk of transfer to other contacts: Unlike other local or topical formulations of testosterone that may get transferred to other individuals via physical contact, testosterone nasal gels are not transferred to physical contacts of user.
Are There Any Drawbacks Or Contraindications Of Testosterone Nasal Gel?
There are some drawbacks of using testosterone in the nasal gel form. For example, men who have anatomical or physiological defects of nose or those who suffer from nasal issues may experience difficulty in using testosterone nasal gels. The contraindications include:
- Men who have nasal polyps, nasal infection or active nasal inflammatory condition.
- Men who have a history of nasal or sinus surgery in the past 6 months.
- Men who have a history of nasal fracture or an anatomical defect.
- Individuals who have mucosal inflammatory condition (2).
Other undesired effects of testosterone gels are:
- Depending upon the dosing frequency and regimens, plasma levels may vary significantly.
- Since nasal gels are extremely new delivery form of testosterone, there are not many product/ brand choices available currently (3).
- The formulation must be applied every day (at least three times) at the same time to minimize the risk of fluctuations in the serum levels of testosterone. Unfortunately, some people may find it a nuisance to remember and apply the gel in the timely manner.
- In some cases, the gel may fail to restore normal/ desired serum testosterone levels. According to data reported in the phase III clinical trials of FDA report, after 90 days of administration (as per the instructions), about 10% subjects failed to achieve normal testosterone levels. The mean concentration of testosterone on day 90 of therapy was 421 ng/dL (1).
Is Testosterone Nasal Gel Easily Available In The Market?
Currently, there is only one FDA approved testosterone nasal gel formulation, which is sold under the brand name ‘Natesto’. The dosing frequency or regimen may vary from person to person, but generally nasal gels should be consumed at least thrice a day (6-8 hours apart) for best results and consistent testosterone levels. The formulation is available in the form of a dose-mastered device that delivers 5.5mg of testosterone with one actuation (thereby making 11mg per dose for two nostrils). If used by this regimen, the total dose per day consumed is 33mg.
Based on the results of Phase III clinical trials that were conducted for the final approval of Natesto, investigators discovered that normal/desired serum testosterone levels were achieved in more than 90% subjects when the gel was used thrice a day (morning, afternoon and evening). On the contrary, when gel was applied twice a day, only 71% men achieved desired plasma levels.
Speak to your doctor to learn if testosterone nasal gels are appropriate for you.
References
1. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205488s000lbl.pdf
2. Rogol, A. D., Bryson, N., & Tkachenko, N. (2015). SAT-122: A Novel Testosterone Nasal Gel Formulation Normalizes Androgen Levels in Hypogonadal Men.
3. Rogol, A. D., Tkachenko, N., & Bryson, N. (2015). Natesto™, a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men. Andrology.
4. Yadav, S., Sharma, P. K., Goyal, N. K., & Bhandari, A. (2014). Nasal Drug Delivery with Special Focus on In-situ Mucoadhesive Gel: A Review. African Journal of Basic & Applied Sciences, 6(4), 115-124.