High Dose Oestrogen HRT Regimes Guideline

The British Menopause Society (BMS) have recently updated their recommendations for progesterone dosage in women using higher doses of oestrogen as part of their HRT. This does not apply to women only using vaginal oestrogen. High dose oestrogen is defined as:

• 100mcg patch
• 4 pumps of oestrogel
• 3mg Sandrena
• 6 sprays Lenzetto
• 4mg oral estradiol

As you may recall from when you started HRT, whenever we give oestrogen to women with a uterus (womb) it is very important that we give them progesterone alongside it. If we were to give oestrogen without progesterone the lining of the womb (endometrium) can thicken and over time this can lead to endometrial cancer. The progesterone protects the endometrium from this risk. Signs that would prompt us to consider investigations for endometrial cancer would be any bleeding that occurs over 12 months after your periods have stopped or a change in your bleeding pattern if you still have periods (more frequent, heavier, or prolonged bleeding).

As you may also remember the reason that we tend to use Utrogestan (also known as micronised progesterone) for the progesterone component is that the data suggests this carries very little or no increased risk in breast cancer.

The new BMS guidelines state:

“There are insufficient data to advise on endometrial cancer risk when micronised progesterone, at a dose used for low or standard dose estrogen, is used in combination with moderate or high dose estrogen. Until evidence relating to safety with moderate and high dose estrogen is available, a pragmatic approach needs to be considered, as the risk to breast tissue from increasing the progesterone dose is also unknown; the use of 200 mg as a continuous preparation [this means if you are taking it daily] and 300 mg as a sequential preparation [this means if you are taking it for 2 weeks out of every 4] should be offered if using high dose estrogen”.

In view of these new guidelines you have four options going forward:

• Reduce your oestrogen dose
• Increase your progesterone dose as above – accepting that we do not know if there is an increased risk of breast cancer associated with this regime
• Continue on your current regime – accepting that there may be an increased risk of endometrial cancer associated with this regime. If you choose this option it is very important that you report any vaginal bleeding (if your periods have stopped) or change to your bleeding pattern (if you are still having periods)
• Consider having a Mirena coil as the progesterone part of your HRT regime – this provides excellent protection against endometrial cancer on all doses of HRT and has little or no increased risk of breast cancer. Once the coil has been fitted it works for 5 years before needing to be changed. It also provides contraception if you need it. After the first couple of months most women will have no bleeding at all with a Mirena www.nhs.uk/contraception/methods-of-contraception/ius-hormonal-coil

HRT prescribing

In April 2023 there was a joint safety alert from the British Menopause Society Faculty of Sexual Reproductive Health, Royal Colleges of General Practitioners, and Royal Colleges of Obstetricians and Gynaecologists.  This was regarding growing awareness that there were increasing numbers of women who were being started on high doses of oestrogen that exceeded product licenses.  Oestrogen should not be regularly prescribed in doses higher than the upper limit listed and tested in clinical research.  The British Menopause Society have produced this table detailing different preparations of oestrogen and when they would be considered to be ultra-low, low, standard, moderate or high dose, though please note that for women on oral oestrogen, decisions around prescribing can be more complex to take into account the risk of clotting:

* Off-license use ^ Off-license use – rarely required to achieve symptom control mg = milligrams µg = micrograms

We are aware that some private providers are happy to prescribe above the recommended limits of oestrogen, as documented above. In such a scenario, our practice policy is that we would no longer be able to prescribe anything that contributes even in part to this overall treatment dose as there could be a risk to your safety with long term use of doses above recommended guidelines.

If this applies to you and you have been prescribed higher than recommended doses of oestrogen, we would therefore ask you to source all your medication supply privately or failing this to reduce your prescribed oestrogen dose. If you are feeling unable to reduce your oestrogen dose, and are unable to fund this privately, please speak to us about the option of being referred into the NHS complex menopause clinic for further management as an NHS patient.

If you believe that you may be on a dose higher than this, or a combination of different Oestrogen products (this does not include vaginal oestrogen cream 0.1% or pessary 10mcg) then please do make an appointment with our clinical pharmacist so that we can go through the potential risks with you and help to make your HRT safe.

We have attached for your convenience a British Menopause Society News update and a link to the full technical statement is available on this website: https://thebms.org.uk/2023/04/joint-bms-fsrh-rcgp-rcog-sfe-and-rcn-womens-health-forum-safety-alert/

If you’d like to discuss this with your preferred GP or Prescribing Pharmacist, please fill in an online Triage Form and someone will get back to you to arrange this.