Hormone replacement therapy for menopausal women

Patient Information Leaflet

What is HRT?

Many women experience menopausal symptoms that affect their quality of life. Hormone replacement therapy (HRT) is the most effective form of treatment. It helps to replace the hormone oestrogen in your body, which decreases around your menopause. You may sometimes also need other hormones (such as progestogen and testosterone) that your body is no longer producing. If you are interested in taking HRT, your healthcare professional should discuss the benefits and risks with you before you start the treatment. You should also be informed about available alternatives to HRT along with their benefits and risks.

What are the types of HRT?

Oestrogen only: Oestrogen is the most effective hormone to relieve menopausal symptoms. Women who have had a hysterectomy only need to take oestrogen. Women who have not had their womb removed (a hysterectomy) are not suitable for oestrogen-only HRT because progestogen is needed to prevent the lining of your womb becoming thickened, which can lead to abnormal cells developing. It is therefore particularly important that if you have not had a hysterectomy then you must have progestogen within your HRT.

Combined HRT (Oestrogen and Progestogen)

Cyclical combined HRT: If you start HRT when you are still having periods, or have just finished periods, you will normally be advised to use a ‘cyclical combined HRT’ preparation. You take oestrogen every day, but progestogen is added for 14 days of each 28-day treatment cycle. This causes a regular bleed every 28 days, similar to a light period. They are not ‘true’ periods, as HRT causes ‘withdrawal’ bleed every 28 days when the progestogen part is stopped. This is normally advised for women who have menopausal symptoms but are still having periods.

You may switch to a continuous combined HRT (see below) if you have been taking cyclical combined HRT for at least one year; or it has been at least one year since your last menstrual period.

Continuous combined HRT: If your periods have stopped for a year or more, you are postmenopausal. If this is the case, you will normally be advised to take a ‘continuous combined HRT preparation’. This means that you take both an oestrogen and a progestogen every day. You may have some irregular bleeding in the first 3-6 months after starting this form of HRT. You should see your doctor if this bleeding continues for more than six months after starting HRT, or if you suddenly develop bleeding after some months with no bleeding.

Testosterone: Testosterone gel is sometimes prescribed to menopausal women who complain of low sexual desire if HRT alone is not effective. This is an off-license usage, meaning this medication is not formally approved or regulated for this use.

Tibolone: Tibolone is taken as a synthetic hormone taken as an oral tablet. It has some oestrogen, progesterone, and testosterone effects. It provides a ‘bleed free’ option and it is normally prescribed at least 12 months after the last menstrual period. Tibolone has also been shown to be particularly useful in women who are known to have endometriosis and fibroids as it does not appear to stimulate these conditions.

Where does HRT come from?

The oestrogens which are used in HRT are taken from natural sources; some from wild yams and some from the urine of pregnant mares which are kept in very humane conditions. Please check with your doctor if you have a particular preference.

How is HRT given?

HRT is given by various routes. It can be given as a tablet, patch, gel, spray, vaginal tablets, or as an implant. The choice depends on individual risk factors and preferences.

Tablets: Tablets containing the hormone(s) can be taken daily. This method is the most common form of HRT and usually does not cause any problems with other prescribed medications. The tablets often come in a calendar pack to help you to remember to take them.

Patches: Patches are preferred and considered safer as they do not cause an increased risk of clots or interfere with other medications. The best place to apply your patch is your buttocks (where your trouser pocket would be). Try to massage the patch with your hand for 30 seconds, this warms the adhesive, so the patch adheres well and reduces the risk of the patch becoming loose, falling off with exercise, or when bathing. If you have some sticky residue on removing the patch, the easiest way to remove this is with surgical spirit or baby oil. Try to avoid using body lotions around application.

Gels: Gels (sachet/pump) should be applied to the inner or outer thigh/ upper outer arm/flat surface of the body. Try to smear the gel on the skin and allow it to absorb (otherwise it can take a while to rub in) and avoid washing your hands until they are also dry. This maximizes the gel being absorbed effectively. Avoid contact with others in your family while the gel is wet on your skin and if you can wait until it is dry. If you still have your womb, you will also need to take separate progestogens.

Spray: The spray should be applied to the inner forearm (between the wrist and elbow). It is important each spray does not overlap with another so ensure you use a different area of forearm with each dose, if needed using both forearms. Use 1 to 3 sprays and leave it to dry for 90 seconds.

Mirena: The Mirena is an intrauterine system (coil placed inside the womb) that delivers progestogen into the womb. It can be used as the progestogen component of HRT for 4 years, so women will need to take oestrogen in addition to this. The Mirena can minimise the unwanted effects of the PMS-type symptoms of the menopause. It is also a contraceptive and can reduce blood loss from heavy periods, sometimes stopping periods altogether.

Vaginal Oestrogens: Vaginal oestrogens are delivered in small tablets, creams or pessaries and give very small doses of oestrogen to the surface of the vagina. They are used to provide vaginal lubrication, treat vaginal dryness, and can be used alongside other HRT treatments or on their own. This alone may be enough to relieve symptoms in some women who would prefer this option or who cannot take other forms of HRT. Progestogen is not needed since these local doses of oestrogen do not affect the womb lining. They are now available to buy from pharmacies over the counter.

Side effects

Side effects with HRT are not common however in the first few weeks some people may develop:

• Breast tenderness or discomfort
• Leg cramps
• Feeling sick (nausea)
• Indigestion or bloating
• Vaginal bleeding
• Weight gain

Side effects usually pass in the first few weeks, and you can do some things yourself to try and help with the side effects:

• Doing regular exercise and stretching to aid with the cramps
• Taking oestrogen with food which may help settle the feeling of indigestion, bloating and nausea
• Eating a lower fat diet with higher carbohydrates

If the side effects persist then you can have a discussion with your doctor, and it may be recommended that the way you take the Oestrogen is changed.

What are the benefits of HRT?

• Symptom relief: The main benefit of HRT is that it provides relief from menopausal symptoms which can be disruptive to your quality of life and can last for a few years. These symptoms include hot flushes, night sweats, tiredness, low mood, anxiety, sleep disturbance, and skin and vaginal dryness.
• Prevention of disease
• Coronary artery disease: Cardiovascular disease is the leading cause of death in women worldwide, 28,000 women in the UK die from heart disease each year. Evidence has shown that women who use HRT within 10 years of the onset of menopause have a reduced risk of coronary heart disease (around 50%) and death related to heart disease. It is therefore recommended that women under 50 years of age who have had a spontaneous or surgical menopause should use HRT.
• Osteoporosis: If you are under 60 years of age and are at risk of developing or have osteoporosis then HRT can be used both to prevent and treat osteoporosis. Evidence demonstrates twenty fewer cases per one thousand users. It can help to improve joint pains and reduce loss of muscle mass and strength.

What are the risks of HRT?

• Heart disease: There may be a small increased risk of heart disease when HRT is started in older women (over 60) of up to five more cases per one thousand users over 7.5 years, or those who already have some form of heart disease.
• Stroke: HRT in tablet form slightly increases your risk of stroke, although the overall risk of stroke is extremely low if you are under the age of 60 years. There is a slight increase in risk of up to five more cases per one thousand users over 7.5 years. These figures are in fact very small and equate to less than 0.1% above the baseline rate for women who are not on HRT.
• Blood clots: There is no increased risk of blood clots with HRT patches or gels. HRT tablets can increase risks of blood clots however this risk is also small. In someone not taking HRT their risk is around 1 in 10,000 women per year. With women who take HRT it is 3 in 10,000 women per year. This is for the initial few months and drops slightly after one year of starting HRT.
• Dementia: The effect of HRT on the risk of dementia remains unclear, with studies reporting conflicting results.
• Type 2 Diabetes: There is no increased risk of developing Type 2 diabetes.
• Gallstones: Using HRT can also lead to an increased risk of gallstones, and/or can bring to light gallstones that were already there but not causing any symptoms. A gallstone is a hard mass made up of bile pigment and can cause pain and indigestion.
• Ovarian cancer: HRT causes a very small increase in the risk of developing ovarian cancer in women who have had a hysterectomy and use oestrogen-only HRT for more than 10 years.
• Cancer of the womb: There is an increased risk of womb (uterine) cancer due to the oestrogen part of HRT. However, by taking combined HRT containing oestrogen and progestogen, this risk reduces completely. You should always see your doctor if you have any abnormal vaginal bleeding which develops after starting HRT. For example, heavy bleeding, irregular bleeding, or bleeding after having sex.
• Breast cancer: In the UK, 1 in 16 women (6.3 in 100 cases) who never use HRT develop breast cancer between 50 to 69 years of age.

Recent research suggests that the risk of breast cancer is increased for all women taking HRT, however, this risk is much lower than previously thought. The increased risk depends on the type of HRT you take and how long you take it for. For example, for women starting HRT at age 50 and taking it for five years, an extra one woman will be diagnosed with breast cancer between age 50 and 69 years for every:

• 50 women taking continuous combined HRT
• 70 women taking combined monthly cyclical HRT
• 200 women taking oestrogen-only HRT

It is important to balance the risks of breast cancer related to HRT use with risks associated with choices we make about our lifestyle. For example, the risk is increased as follows (per 1000 women over 6 years):

• Being overweight (BMI 25-29): by 4 extra cases
• Obesity (BMI >30): by 10 extra cases aged 50-59
• Drinking alcohol 4-6 units per day: by 8 extra cases
• Drinking alcohol >6 units per day: by 11 extra cases
• Smoking: 3 extra cases

There appears to be no increase in the risk of breast cancer when HRT is used for less than 3 years. Most women only need HRT for a few years and the additional risk caused by using HRT declines rapidly after stopping it. However, a background population risk will remain, and you should still attend for breast screening when requested. Of note, oestrogen‑only HRT (i.e. without any progestogen) causes little or no change in the risk of breast cancer.

What non-hormonal (non-HRT) treatment options are available?

You may not want to use HRT due to a personal or family history, or if you have concerns about safety or side effects of the drugs.

• Vaginal lubricants and moisturizer – symptoms of soreness with intercourse due to dryness can be treated with lubricants such as Yes VM or Yes WB* (water based, both available on NHS Prescription), or Yes OB (oil based, Yes OB is not currently available on NHS prescription).
• Alternative therapy – the role of alternative therapies such as, acupressure, acupuncture, reflexology, or homeopathy is not known in managing menopausal symptoms.
• Herbal medicines – these medicines are not regulated by the medicine authority and their safety is unknown. These can react with drugs used for treatment of breast cancer, epilepsy, asthma, and heart disease. There are reports that some plant preparations can help to reduce the symptoms of hot flushes and night sweats, such as St. John’s wort, black cohosh, and iso-flavones (contained in soya beans).
• Bioidentical hormones – bioidentical hormones come from soya and plant extracts and are modified to be structurally identical to natural body hormones. The amount of active ingredient contained in these preparations is not monitored and varies widely from batch to batch. That is why these medications are not recommended and are not licensed in the UK.
• Antidepressants – some low dose antidepressants called SSRI/SNRI can also reduce hot flushes by 60%, but if they are taken at the dose for depression. Another medication used to control epilepsy is also used to reduce hot flushes. You can discuss the benefits and risks of each of these with your doctor who will tell you if any are suitable for you.
• Psychological treatments – is a talking therapy that can be helpful for managing mood as well as hot flushes and night sweats. It focuses on the effect of your thoughts and beliefs on your feelings and behaviour. There is a fact sheet (written by Myra Hunter) on the Women’s Health Concern website which provides guidance on cognitive behavioural therapy in a self-help format for women to access directly.
• Neurokinin 3 antagonist– VEOZAH is a new non-hormonal prescription treatment designed to specifically block neurokinin B (NKB). This is available on private prescription only for moderate to severe hot flushes and night sweats due to menopause.

Do I still need to use contraception when taking HRT?

HRT does not provide contraception. You need to continue using contraception for 1 year after your last period if this happens after the age of 50 years. If your last period happens before you are 50 years of age, then you need to continue using contraception for 2 years.

When should I seek advice after starting HRT?

You should have a review appointment with your healthcare professional after 3 months of starting or changing HRT, and then yearly thereafter if all remains well. You may notice some vaginal bleeding in the first 3 months of starting or changing HRT, but if you experience any bleeding after 3 months then you should see your healthcare professional straight away.

How long can I take HRT for?

There are no set time limits for how long you can be on HRT. The benefits and risks of taking HRT will depend on your individual situation, and your healthcare professional should discuss these with you.

What will happen if I stop HRT?

No medical harms are associated with stopping HRT and you can stop it without seeing a healthcare professional. However, stopping gradually may help to prevent symptoms of the menopause from coming back. Your doctor, nurse, or pharmacist can advise you on how best to do this.

NHS Prescription Prepayment Certificate (PPC)

A PPC could save you money if you pay for your NHS prescriptions. The certificate covers all your NHS prescriptions for a set price. You will save money if you need more than three items in 3 months, or eleven items in 12 months. Useful link: NHS HRT prescription prepayment certificate

Can I find out more?

You can find out more from the following web links:

RCOG Menopause Hub
www.rcog.org.uk/en/patients/menopause

Menopause Matters
https://menopausematters.co.uk

Women’s Health Concern
www.womens-health-concern.org/

British Menopause Society
https://thebms.org.uk/

If you have any questions, or if there is anything you do not understand, please contact the Russells Hall Hospital switchboard number on 01384 456111 and ask for the relevant department who issued this leaflet. If you have any feedback on this patient information leaflet please email dgft.patient.information@nhs.net

This leaflet can be made available in large print, audio version and in other languages, please call 0800 073 0510.

Originator: Ms Sadia Ijaz, Consultant Gynaecologist Date originated: April 2024. Review date: January 2027 Version: 1. DGH ref.: DGH/PIL/02199