Prescribing information for testosterone

Most doctors do not have any experience of prescribing testosterone for women but there is now more discussion about this. The NICE guidelines (NG23) do indicate that some women may benefit from adding in testosterone if their libido is still low despite being well established on a suitable dose of HRT. There are many factors that contribute to sex drive so testosterone is not always the answer, but many women understandably want to try it.

The current medical evidence for adding testosterone is only for an improvement in libido. Some women report that it helps their mood, motivation, concentration, cognition or energy levels but the randomised clinical trials done so far have not shown these benefits. Further research is being planned but we do know that testosterone replacement is particularly important in women who have had their ovaries removed. Many women do not experience a sudden drop in testosterone in the menopause transition or feel fine with a low level so not every woman needs testosterone.

Before considering if testosterone is needed, estrogen needs to be transdermal and at a dose that improves most symptoms. If you are on oral estrogen, please talk to your HCP about changing to transdermal estrogen and you will need to try this for at least 3 months before being seen in the clinic. If you are on a low dose of transdermal estrogen and still getting lots of symptoms, this can be increased to a more standard dose before considering testosterone.

Testosterone for women is now green on the Somerset prescribing formulary but HCPs do need to do some extra training to become familiar with who might benefit from it and how to prescribe it to women safely. Not all HCPs will feel confident to prescribe testosterone but hopefully in the future there will be at least one HCP in each practice who will be able to offer this. In the meantime, patients can be referred to this service.

GUIDANCE FOR PRESCRIBING TESTOSTERONE FOR HEALTH CARE PROFESSIONALS  July 2022

Prescribing guidelines from the British Menopause Society were updated in May 2022. Please see the BMS document on ‘Testosterone replacement in menopause’ which can be found in the ‘Tools for Clinicians’ section. Ideally you would attend an education session as well as reading this.

The available products have also changed.

BLOOD TESTS

Blood tests for testosterone, and sex hormone binding globulin are now suggested before starting testosterone. The laboratory may not need to process the SHBG if the testosterone level is very low. An estradiol level can occasionally be useful but only if the patient is on the maximum recommended dose of an estrogen gel or patch but is still getting lots of symptoms.

If checking the estradiol level, any estradiol gel normally applied in the morning should be omitted until after a morning blood test. If using an estrogen patch, the blood test is best done on day 2 of the patch.

Please send the blood results with the referral. Calculating the Free Androgen Index is no longer considered helpful.

PRESCRIBING OPTIONS

1. Testosterone gel should be applied to clean, dry skin of the lower abdomen, buttock, or outer thigh, rotating the site of application to avoid hair growth in one area. It should be allowed to dry before dressing. Skin contact with partners and children should be avoided until dry and hands should be washed immediately after application. The area should not be washed for 3 hours after application.
2. The patient should be on transdermal estrogen at a sufficient dose to relieve most symptoms before considering if testosterone supplementation is needed.
3. Blood tests for testosterone and sex hormone binding globulin (SHBG) levels are now suggested before starting testosterone. This is done to check that a patient doesn’t already have a testosterone level at the top end or above the upper limit of the female reference range.
4. Blood tests are also needed 6 to 8 weeks after initiation or any dose change and then every 6 to 12 months once stable. This is to make sure the levels are still within the female reference range.
5. A review is needed 3 months after initiation to discuss the blood test result and check for any side-effects or benefits.
6. It can take at least 3 months to notice any difference in symptoms. If no improvement after 6 months of use then we would suggest stopping it.
7. If taking it long-term, patients need a blood test every 6 to 12 months and at least an annual review.
8. Common side-effects when starting testosterone are greasier hair and skin, spots, increased irritability, hair thinning and weight gain. If these symptoms don’t settle quickly the dose can be reduced before the 3 month review (but patients must never increase the dose).
9. Serious and possibly irreversible side-effects can develop if the dose is too high. These include male pattern hair loss, deepening of the voice, increased body and facial hair, and very rarely an enlarged clitoris. Very occasionally women with normal blood levels can also develop these side-effects.
10. Please warn patients that the patient information leaflet only relates to male use and give them the patient information leaflet from either the British Menopause Society or Women’s Health Concern.
11. We don’t have much long-term safety data on the use of testosterone in women so it is important that patients have the annual review to discuss benefits, any side-effects, their blood levels and any emerging evidence.
12. We do not recommend giving testosterone supplementation to women who are not already on HRT.

WOMEN WHO SHOULD AVOID TESTOSTERONE

• During pregnancy or breast-feeding
• Active liver disease
• History of breast cancer
• Women with upper normal or high baseline testosterone levels
• Competitive athletes