FAQ: How is off-label testosterone dosed and monitored in women?

This FAQ is a summary of the discussion in the third episode of the Special Report series Testosterone in women: The evidence-practice gap in the US. In the episode, Maria Uloko, MD, a board-certified urologist specializing in comprehensive sexual health, asks Bruce Dorr, MD, FACOG, URPS, FMCP-M, a board-certified ob-gyn with subspecialty training in urogynecology, why testosterone prescribing for women is so inconsistent in the United States and what keeps clinicians from putting the evidence into everyday care.

The panelists focus on the mechanics: dosing, application, cost, and monitoring. The answers below come from their remarks in the episode and reflect their own clinical experience.

Why is every US testosterone prescription for women off-label?

Dorr said seven randomized controlled trials in the early 2000s showed that women with hypoactive sexual desire disorder improved about 80% of the time on testosterone, but the formulation was never approved. “Because there's no FDA approved female testosterone product, we have to go off-label,” he said. “Frustrating for me, frustrating for the community, and certainly frustrating for patients,” Dorr said.

What dose do the panelists use?

Dorr said the female dose is about 10% of what male products deliver. Uloko described the guideline math: “The female dose for daily testosterone delivery is 1/10 of the dose that men get.” Men typically receive at least 50 mg, she said, and women 5 mg.

Because the only standard product is a male-equivalent dose, one tube lasts a woman about 10 days. “10 to 14 days is typically what I tell people,” Uloko said, noting the imprecision: “you're trying to guesstimate 5 milligrams delivery every day.”

Why can't clinicians simply scale down a male dose?

“Women are not little men,” Dorr said. “Some people's skin, if we're doing transdermals, allow things in fantastically, and other people, not at all.”

Dorr said he has seen patients who began using a partner's testosterone injections develop hair loss and other androgenic adverse events from inappropriate dosing. He said clinicians must watch quality, consistency, and patient compliance, and keep the decision shared in this off-label setting.

How should patients apply it?

“You apply that directly to the calf, back of the calf, you wash your hands, and you wait for that area to dry,” said Uloko. Because dosing is imprecise, she said, “it's really important to be able to show the patient,” and she has patients demonstrate application in clinic to confirm they are doing it correctly.

What about cost and insurance?

Uloko said she often recommends against using insurance because insurers “will not cover it,” which can produce an “astronomical” price. In her experience, “GoodRx actually has really amazing coupons that can get you a year's supply for about less than $100, which is not, again, feasible for everyone, but it is better than the alternative.”

How should clinicians monitor patients?

Uloko said she prefers “trending the labs” to guessing, checking both efficacy and safety. If symptoms are not improving, labs can show whether the patient is absorbing the product or needs another formulation. She also tracks side effects against lab values: “at any given point in time, if people are having side effects or symptoms, I want to know at what lab value that's happening, so that we can document that.”

She said safety levels are not well defined, calling this “more of an expert-level conversation” and an area where better guidelines are needed.

This FAQ was developed as a summary of the Special Report series discussion. To hear the full conversation, watch the complete series, Testosterone in women: The evidence-practice gap in the US.