Testosterone for low libido (DRAFT)

Overview

**November 24: work is ongoing regarding the approach to testosterone prescription in primary care. We will update Remedy regarding this once complete**

Levels of testosterone in women decline between the ages of 20 and 40. By menopause the levels have plateaued out and are stable. At age 65, endogenous testosterone levels start to increase.  

Testosterone is not the third component of HRT. Unlike oestrogen, there is not a 'relative deficiency' i.e. in most women levels are within the normal female range as production is not just ovarian in nature.  

Managing women with hypoactive sexual desire disorder (lack of desire, change/reduction of orgasm), necessitates a biopsychosocial approach. It is important to consider contributory factors which include vulvovaginal atrophy and relationship issues. 

Criteria for NHS Testosterone Treatment

Use of testosterone gel is restricted in BNSSG to the treatment of low libido causing distress in women with optimised HRT and with either early menopause (age 45 and under) or surgical menopause only. Use of testosterone gel for women outside of this cohort is non-formulary and is not currently supported.  

Testosterone gel is ‘Amber 3 months’ on BNSSG formulary, which means it must be initiated by a menopause specialist (who may sit in primary care). See testosterone shared care protocol 

Referrals

Please ensure criteria are met before referring to the menopause clinic for consideration of testosterone treatment

1. Low libido causing distress and  
2. Ongoing symptoms despite optimised oestrogen and progesterone HRT and
3. All other causes (biopsychosocial approach) have been excluded with
4. Total testosterone <1.5 and either 
   1. early menopause (45 years and under) or
   2. surgical menopause (bilateral oophorectomy) 

If referring for testosterone replacement:  

• Ensure HRT is optimised e.g. oestrogen dose is sufficient – consider increasing oestrogen dose and assessing response after 3 months if other menopausal symptoms (other than libido) are ongoing. 
• For BNSSG lab assays: Total testosterone is <1.5 (upper limit <2.7) 
• Please also check SHBG and include in the referral 

At present, within BNSSG, testosterone should not be prescribed outside of this guidance. There is on-going work to review the current cohorts of women eligible for testosterone, and these pages will be updated with this decision in December 24.

Private Patients

If a patient is started on testosterone privately for a non-formulary indication, then this can be continued privately. NHS prescriptions should only be issued if a patient meets the referral criteria above. If patients are referred to the complex menopause clinic for testosterone, please  note that there may be a 6-12 month wait and they should have 6 monthly monitoring whilst waiting to be seen.

See Referrals for further details 

Shared Care Protocol

In line with the BNSSG Testosterone shared care protocol, once efficacy has been demonstrated and following a 6 month follow up, patients can be discharged back to their GP for on-going care, with support from secondary care advice and guidance platforms as required. Clear advice will be provided in their discharge letter. 

The GP will be responsible for: 

1. Issuing of prescription and adjustment of dose according to the protocol, or on specialist advice, after test results are known to the prescriber. 
2. Notification to the specialist of any changes in the patient’s condition or any adverse drug reactions. 
3. Non-compliance with medications or monitoring: Contacting the patient to ascertain the reason for non-attendance for routine blood tests if more than one test is missed. Communication with the patient that non-attendance for blood testing will lead to withdrawal of the medication. 
4. Severe side effects/potential overdose: urgent referral to the specialist if required
5. Referral of the patient back to specialist if the medicine becomes less effective, and medical conditions / oestrogen HRT has been optimized.

Preparations

Available preparations include: Tostran® 2% gel and Testogel® 40.5mg/2.5g gel sachets.

At present, there is no preparation of testosterone that is licensed for use in women in the UK. All use is ‘off-license’.

Testosterone availability is not currently stable, and the dose and use of preparations are not interchangeable. Women using these medications should ensure they are taking them exactly as prescribed.  

See HRT Prescribing pathway for further details

Contraindications

Please be aware of the following contraindications to testosterone treatment:

• Patients discontinuing oestrogen hormone replacement therapy  
• Supraphysiological free androgen index (>9%)  
• Previous VTE 
• Active liver disease  
• Pregnancy or pregnancy intention  
• Clinical evidence of androgen excess such as clitoromegaly, enlarged labia, deepening voice  
• Oestrogen sensitive conditions such as oestrogen receptor cancers, unstable lupus / catamenial epilepsy 

It should also be used with caution in patients with cardiovascular disease, liver disease, renal insufficiency.

Monitoring testosterone levels

Total testosterone level should remain under the upper limit of the normal range and should be performed 

• 6-12 weeks after initiation 
• 6 months after initiation 
• 12 monthly once levels are stable 

In certain circumstance SHBG can be helpful and you will be guided by a specialist if required.  

Blood tests can be taken in primary care, as per the shared care protocol, the prescriber remains responsible for ensuring levels are up to date before providing prescriptions.

Side effects

Adverse effects of testosterone are uncommon if levels are maintained within the female physiological range.  

Side effects include the following and may not be reversible:  

• Excess hair growth, acne and weight gain  

• Alopecia, deepening of voice, cardiovascular disease and clitoral enlargement are rare but can be irreversible - if levels consistently remain above the normal female range.  

If side effects occur, please check dosage and how it is being used, different preparations have different dosing schedules. Consider reducing dosage or stopping.  

Long term testosterone

Safety data regarding testosterone is limited to 2-3 years follow up and excluded people with cancer, and high cardiovascular risk.  

Woman should have annual reviews that updates her on new evidence and states: 

• The woman is clear there is significant benefit  

• She is happy to accept uncertainty regarding safety of long-term use regarding cancer, stroke, VTE and dementia risk.  

• There is compliance with monitoring 

• There is awareness of off license use. 

Given an increase in endogenous testosterone production around the age of 65, a pragmatic approach is to encourage women to reduce and stop testosterone around this age, or if testosterone levels start to increase.   

Resources

Patient Resources 

• 22-WHC-FACTSHEET-Testosterone-for-women-NOV2022-B.pdf (womens-health-concern.org) 

Some interesting and helpful books on female libido include  

• “Come as you are” by Emily Nagoski  

• “ A tired woman’s guide to passionate sex” and “Becoming Cliterate” both by Laure Mintz. 

Resources and References 

BMS Statement on Testosterone - British Menopause Society (thebms.org.uk) 

Sections A-D and H must be completed by the applicant (icb.nhs.uk) 

Davis SR, Bell RJ, Robinson PJ, Handelsman DJ, Gilbert T, Phung J, Desai R, Lockery JE, Woods RL, Wolfe RS, Reid CM, Nelson MR, Murray AM, McNeil JJ; ASPREE Investigator Group. Testosterone and Estrone Increase From the Age of 70 Years: Findings From the Sex Hormones in Older Women Study. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6291-6300 

Efforts are made to ensure the accuracy and agreement of these guidelines, including any content uploaded, referred to or linked to from the system. However, BNSSG ICB cannot guarantee this. This guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, in accordance with the mental capacity act, and informed by the summary of product characteristics of any drugs they are considering. Practitioners are required to perform their duties in accordance with the law and their regulators and nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

Information provided through Remedy is continually updated so please be aware any printed copies may quickly become out of date.