AIDS TREATMENT NEWS Issue #307, November 20, 1998
Tadd Tobias and John S. James

Since that article went to press, we have learned that cream and gel topical forms of testosterone, which work well for many people, remain available with no supply problems. And the total cost of treatment, which can be less than $20 per month regardless of dose, may be less than with any other form of testosterone available. But we have found that prices for top-quality products can vary greatly--as much as ten times between different pharmacies--and that not all of the cream and gel formulations are of good quality.

These products are available today only from compounding pharmacies--that is, pharmacies willing to mix medications according to physicians' instructions, as opposed to only dispensing medications in prepared forms. Relatively few pharmacies will do this, but some of them can ship mail order, so the products are available anywhere in the U.S. Traditionally, few insurance or health plans have covered compounded medications, but more are beginning to cover topical testosterone as more patients are demanding it. And the cost of the cream or gel can be so much less than the brand-name injectable or patch medications that the co-pay with the latter may be a comparable out-of-pocket expense.

Topical testosterone avoids the need for injections or patches, and may reduce the large variation in blood level of the injected medication, which is commonly given once every two weeks. However, the drug supplied by the cream or gel has a much shorter half-life in the body, so it is usually applied twice a day.

We talked to Kathy Lammer, Pharm. D., of Women's International Pharmacy, which has been in business for 13 years and specializes in compounding hormones which are applied topically in a cream or gel; we were referred to her by AIDS treatment expert Lark Lands, Ph.D. She told us that there is no shortage of their product, which can be prepared in either cream or gel form, in any concentration from 1 to 100 milligrams/gram (some pharmacies indicate concentration in percent; 100 mg/gm is 10% testosterone). A one-month supply (60 grams of cream or gel) costs $17.21 regardless of the concentration--a price that Women's International Pharmacy has not raised in 13 years. It comes with a measuring device and instructions on applying one gram twice per day. The source of this company's testosterone is the soybean plant (but it can be used by people with soybean allergies).

In Dr. Lammer's experience, older men who are being treated for hypogonadism usually use the 25 mg/gm strength twice daily, while men with HIV often use 50 mg/gm twice daily. Women use much lower doses, usually the 2 to 5 mg/gm concentrations twice daily. Men have usually preferred the gel, which is alcohol based, and women have usually chosen the cream, which is safflower-oil based. In all cases, the usual amount of the cream or gel applied is 1 gram twice per day. Men often apply it to the scrotum, because absorption may be better there since the skin is thin.

The prescriber must be a licensed M.D., D.O., P.A., or N.P. with a DEA number, since testosterone is a Schedule III controlled substance; some states require a triplicate prescription--an inconvenience for doctors--but others do not. There can be up to five refills, but no more since a prescription for a controlled substance is only valid for six months; then a new prescription is needed. Most physicians are not familiar with prescribing topical testosterone; the prescription can say "testosterone ? mg/gm, apply one gram twice per day," where the concentration is usually 50 mg/gm or 25 mg/gm for men, much less for women.

When purchasing testosterone cream or gel, it is important to choose a pharmacy which has experience compounding this product. We know of one case where a major pharmacy tried preparing it, but the drug did not remain properly in the suspension.

Women's International Pharmacy can be reached at 800-279-5708 (9 a.m. to 5:30 p.m. Arizona time). For additional information, see its Web site at http://www.wipws.com.

We know of other compounding pharmacies which are also reputed to have good products. But they are much more expensive, and we have no reason to believe that they are better.

Note: UNIMED Pharmaceuticals is developing a form of topical testosterone for FDA approval as a packaged product (not compounded by the pharmacy). It is unlikely to be available until at least mid 1999. Probably it will be expensive, but covered by most health plans.

Comment--Biodiversity

We believe that environmental and biodiversity organizations should be aware of topical testosterone, because it might have a role in saving some endangered animal species. Certain species are hunted because some elderly men use animal products to revive lost sex drive. It is likely that they are suffering from hypogonadism, and that testosterone replacement would work at least as well as the animal parts, reducing the killing of endangered species. The cream or gel formulations may be more readily accepted than testosterone injections or patches. If this treatment works in these cases, people would use it if they knew about the possibility.

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