Hormone Replacement Therapy (HRT) for Menopausal Symptoms

NHSL Medicines Guidance
NHS Lanarkshire

General Notes

The MHRA advises that HRT should only be prescribed to relieve post-menopausal symptoms that are adversely affecting quality of life. Treatment should be reviewed regularly to ensure the lowest effective dose is used for the shortest duration. For osteoporosis, consider alternative treatments. HRT does not prevent coronary heart disease or protect against a decline in cognitive function and it should not be prescribed for these purposes. Experience of treating women over 65 years with HRT is limited.

HRT increases the risk of venous thromboembolism, stroke, endometrial cancer (reduced by a progestogen), breast cancer, and ovarian cancer; there is an increased risk of coronary heart disease in women who start combined HRT more than 10 years after menopause.

In August 2019, new data confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens. It was also shown that an excess risk of breast cancer persists for longer after stopping HRT than previously thought (MHRA Drug Safety Update August 2019). Prescribers are advised to discuss the updated total risk with women using HRT.

MHRA Patient Information Sheet - 'Hormone replacement therapy and risk of breast cancer'

Please note - due to ongoing HRT shortages this formulary section may be subject to change.

The Scottish Government has released new circulars outlining the introduction of temporary serious shortage protocols (SSPs) to help pharmacy teams manage demand for HRT products in short supply.

Estradiol Only

Preferred list (P)

EVOREL® transdermal patch

  • Twice weekly patch change
  • Strengths:
    • Estradiol 25 microgram/24 hours
    • Estradiol 50 microgram/24 hours
    • Estradiol 75 microgram/24 hours
    • Estradiol 100 microgram/24 hours

ELLESTE SOLO® tablets

  • Strengths:
    • Estradiol 1mg
    • Estradiol 2mg

 

Total list (T)

OESTROGEL® transdermal gel

  • Strength: estradiol 0.06%
  • Indicated for women without a uterus.
  • In women with an intact uterus it is recommended to add a progestogen (e.g. a progesterone) for at least 12 days of each month, in accordance with the manufacturers' recommendations.

FEMSEVEN® transdermal patch

  • Once weekly patch change
  • Strengths:
    • Estradiol 50 microgram/24 hours
    • Estradiol 75 microgram/24 hours
    • Estradiol 100 microgram/24 hours

 

Sequential Combined HRT

Preferred list (P)

EVOREL SEQUI® transdermal patch

  • Twice weekly patch change
  • Estradiol only for two weeks, then estradiol and norethisterone together for the next two weeks.
  • Contains:
    • 4 x ‘Evorel 50’ patches containing 50 microgram/24 hours estradiol only (marked CE50).
    • 4 x ‘Evorel Conti’ patches containing 50 microgram/24 hours estradiol and 170 microgram/24 hours norethisterone (marked CEN1).

ELLESTE DUET® tablets

  • 1mg - one white tablet daily for the first 16 days, followed by one green tablet daily for the next 12 days.
    • Contains:
      • 16 x white tablets containing 1mg estradiol.
      • 12 x green tablets containing 1mg estradiol and 1mg norethisterone acetate.
  • 2mg - one orange tablet daily for the first 16 days, followed by one grey tablet daily for the next 12 days.
    • Contains:
      • 16 x orange tablets containing 2mg estradiol.
      • 12 x grey tablets containing 2mg estradiol and 1mg norethisterone acetate.
  • A new cycle should then begin without any break.

 

Total list (T)

FEMSEVEN SEQUI® transdermal patch

  • Once weekly patch change
  • Estradiol only for two weeks, then estradiol and levonorgestrel together for the next two weeks.
  • Contains:
    • 2 x phase 1 patches containing 50 microgram/24 hours estradiol only.
    • 2 x phase 2 patches containing 50 microgram/24 hours estradiol and 10 microgram/24 hours levonorgestrel.
  • Current supply disruption - alternative is Evorel Sequi® patch (twice weekly patch change).

FEMOSTON® tablets

  • 1/10mg - one white tablet daily for the first 14 days, followed by one grey tablet daily for the next 14 days.
    • Contains:
      • 42 x white tablets containing 1mg estradiol.
      • 42 x grey tablets containing 1mg estradiol and 10mg dydrogesterone.
  • 2/10mg - one brick-red tablet daily for the first 14 days, followed by one yellow tablet daily for the next 14 days.
    • Contains:
      • 42 x brick-red tablets containing 2mg estradiol.
      • 42 x yellow tablets containing 2mg estradiol and 10mg dydrogesterone.
  • A new cycle should then begin without any break.

 

Continuous Combined HRT

Preferred list (P)

EVOREL CONTI® transdermal patch

  • Twice weekly patch change
  • Strength:
    • Estradiol 50 microgram/24 hours and norethisterone 170 microgram/24 hours.

KLIOVANCE® tablets

  • One tablet daily without interruption, preferably at the same time every day.
  • Stength:
    • Estradiol 1mg and norethisterone 0.5mg.

KLIOFEM® tablets

  • One tablet daily without interruption, preferably at the same time every day.
  • Strength:
    • Estradiol 2mg and norethisterone 1mg.

Total list (T)

FEMSEVEN CONTI® transdermal patches

  • Once weekly patch change
  • Strength:
    • Estradiol 50 microgram/24 hours and levonorgestrel 7 microgram/24 hours.

FEMOSTON CONTI® tablets

  • One tablet daily without interruption.
  • Strength:
    • 0.5mg/2.5mg
      • 0.5mg estradiol and 2.5mg dydrogesterone.
    • 1/5mg
      • 1mg estradiol and 5mg dydrogesterone.

Topical Vaginal Oestrogen

Preferred list (P)

ESTRIOL 1mg/g (0.1%) cream 

  • Excipients: cetostearyl alcohol (including cetyl and stearyl alcohol), polysorbates.
  • One applicator-dose holds 0.5g of cream containing 0.5 mg estriol.

 

Total list (T)

ESTRADIOL 10 microgram pessary

  • One tablet nightly for 2 weeks then twice weekly maintenance.
  • Available as Vagirux® or Vagifem®. Vagirux® is currently more cost-effective.
  • Please note the applicator differences below when considering which preparation to prescribe, as this is the only difference:
    • Vagirux® vaginal tablets are inserted using a multiple dose applicator which the tablets are placed into. The applicator should be washed after each use and used up to a maximum of 24 times. A new applicator should be used with each pack.
    • Vagifem® vaginal tablets are inserted using a single-use prefilled applicator. Each pack contains 24 single-use plastic applicators.

ESTRADIOL 7.5 microgram per 24 hour vaginal delivery system (Estring®)

  • Replace after 3 months. Maximum duration of continuous treatment is 2 years.

 

Specialist use only (S2)

ESTRIOL 0.01% cream

  • For secondary care clinic use.
  • May contain arachis (peanut) oil, cetostearyl alcohol (including cetyl and stearyl alcohol) and polysorbates.
  • One applicator-dose holds 5ml of cream containing 0.5mg estriol.

Progestogen as Part of HRT

Preferred list (P)

LEVONORGESTREL 20 microgram per 24 hour intrauterine device (Mirena®)

  • Effective for 4 years.

 

Total list (T)

MEDROXYPROGESTERONE ACETATE tablets (Provera®)

 

Other

Total list (T)

TIBOLONE 2.5mg tablets

  • Short-term treatment of symptoms of oestrogen deficiency (including women being treated with gonadotrophin releasing hormone analogues).

Non-Hormonal Vaginal Moisturiser

Preferred list (P)

Sylk® 40g tube

  • 40g tube sufficient for 75-150 applications.
  • There are on-going supply issues with Sylk®. Alternative options are being explored.

 

Total list (T)

Regelle® applicators

  • Reserved for patients requiring an applicator.
  • Each application lasts for up to 3 days. 6 single use pre-filled applicators = up to 18 days’ supply.

 

NHSL Joint Adult Formulary Key

To indicate the category of a formulary medicine, updated sections adopt the following key:

Preferred list (P): First-line formulary choices.

Total list (T): Alternative choices when preferred list options not effective/not tolerated, or not indicated.

Specialist initiation (S1): Specialist initiation, or on the advice of a Consultant or Specialist Practitioner in this therapeutic area. Continuation in primary care is acceptable.

Specialist use only (S2): Supply via hospital, Homecare Service or a hospital based prescription (HBP) for dispensing by community pharmacy. Not prescribed in primary care setting.

Editorial Information

Last reviewed: 31/01/2022

Next review date: 31/01/2025

Author(s): NHSL.

Version: Please refer to the introduction section for an explanation of the review dates above.

Approved By: ADTC

Reviewer name(s): ADTC.