Elleste Duet

What is Elleste Duet?

Elleste Duet is a form of hormone replacement therapy (HRT). It supplements the natural hormones oestrogen and progesterone to relieve the symptoms of menopause and to prevent osteoporosis in postmenopausal women.

Elleste Duet is NOT a contraceptive. If you are under 50, or if it is less than 12 months since your last period, you may still need to use additional contraception to avoid pregnancy. Speak to your doctor for advice.

How does Elleste Duet work?

Elleste Duet contains synthetic forms of oestrogen and progesterone naturally produced in women. As women approach menopause, their ovaries begin to produce less oestrogen, which can cause symptoms such as irregular periods, mood swings, hot flushes and sweats. Elleste Duet helps to supplement these falling levels and relieve symptoms. Oestrogen also stimulates the growth of the womb lining, which, if allowed to build up, increases the risk of endometrial cancer in women who have not had a hysterectomy, or who do not have a Mirena coil fitted. The progestogen supplement in Elleste Duet counters this effect, inducing a monthly bleed and reducing the risk of endometrial cancer.

Declining levels of oestrogen in women can also lead to a weakening of the bones, known as osteoporosis. Elleste Duet 2mg is also used for short-term prevention of osteoporosis in postmenopausal women.

Active ingredients

The active ingredients in Elleste Duet are estradiol hemihydrate and norethisterone acetate.

Inactive ingredients

The inactive ingredients of Elleste Duet are lactose monohydrate, maize starch, povidone 25, talc, magnesium stearate, hydroxypropylmethylcellose (E464), titanium dioxide (E171), and macrogol 400. There are also various colourings used:

• The 1mg tablets which contain both estradiol and norethisterone (green tablets) also contain quinoline yellow (E104) and indigo carmine (E132). 
• The 2mg tablets which contain estradiol only (orange tablets) also contain sunset yellow (E110).
• The 2mg tablets which contain estradiol and norethisterone (grey tablets) also contain black iron oxide (E172)

Elleste Duet dosage

Always take Elleste Duet as instructed by your doctor. Elleste Duet comes in 1mg and 2mg tablets. The recommended dose is 1 tablet per day at roughly the same time each day.

As this HRT is a continuous sequential regime, you will take one estradiol-only tablet per day (which contains 1mg or 2mg of estradiol) for the first 16 days, followed by one estradiol/norethisterone tablet per day (which contains 1mg or 2mg of estradiol along with 1mg of norethisterone for the next 12 days. The cycle will then repeat.

How to use Elleste Duet?

A pack of Elleste Duet 1mg contains 16 white tablets containing estradiol hemihydrate (oestrogen) and 12 green tablets containing estradiol hemihydrate and norethisterone (oestrogen and progestogen). You will take one of the 16 white tablets each day, followed by one of the 12 green tablets each day. You will then start a new pack.

The Elleste Duet 2mg pack contains 16 orange tablets and 12 grey tablets. You’ll start with the orange tablets. 

If you no longer have regular bleeds, you can start taking Elleste Duet at any time. If you still experience regular bleeds, start taking Elleste Duet on the first day of your bleed. Start at the beginning of a pack with the oestrogen-only tablets, start a new pack the day after finishing the last. You should experience a monthly bleed at the beginning of each pack when you stop taking the oestrogen-progesterone tablets and return to oestrogen only. 

Swallow one tablet a day with some water at around the same time each day. It helps to make this a part of your daily routine – try taking your pill with breakfast every day, or when you brush your teeth. If you forget to take a dose, try and take it within the next 12 hours. If 12 hours have already passed when you remember, just skip the dose and take the next one at the normal time. Never take a double dose to make up for the missed one.

Elleste Duet side effects

Like all medications, Elleste Duet may cause side effects in some people. 

Very common side effects (affecting more than 1 in 10 people) include:

• Headache
• Breast pain or tenderness
• Painful menstrual bleeding
• Changes in menstrual bleeding

Common side effects (affect less than 1 in 10 people) include:

• Mood swings, or feeling down and anxious
• Change in libido
• Difficulty sleeping
• Dizziness
• Nausea
• Diarrhoea
• Indigestion
• Abdominal pain
• Acne
• Rashes, itchiness or dry skin.
• Back pain
• Pain in the extremities
• Breast enlargement
• Heavy periods
• Changes in vaginal discharge
• Spasms of the womb.
• Vaginal infection including thrush
• Excessive thickening of the lining of the womb (endometrial hyperplasia)
• Swelling of the ankles, fingers or feet
• Increase in weight

Uncommon side effects, affecting up to 1 in 100 people, include:

• Migraines
• Vertigo
• High blood pressure
• Varicose veins
• Vomiting
• Gallstones or gallbladder disease
• Change in skin colour
• Muscle cramps
• Breast cancer
• Increased level of liver enzymes

 
Rare side effects (affect up to 1 in 1,000 people) may include the following:

• Hypersensitivity reactions
• Tingling or numbness
• Blood clot in the vein
• Muscle weakness
• Myoma, cysts or polyps in the womb or cervix

Very rare side effects only affect up to 1 in 10,000 people and can include:

• Increase in body and facial hair
• Yellowing of the skin
• Loss of hair from the scalp

Contraindications

Always consult a doctor before starting Elleste Duet. Do NOT take this medication if you:

• Are allergic to any of the ingredients in Elleste Duet
• Are, or might be, pregnant
• Have or have ever had breast cancer
• Have or have ever had endometrial cancer, or any other cancer which is sensitive to oestrogen
• Are experiencing unexplained vaginal bleeding
• Have excessive thickening of the womb lining which is not being treated
• Have or have ever had thrombosis (blood clot in the vein)
• Have a blood clotting disorder
• Have or have recently had a disease caused by blood clots in the arteries e.g. angina or a heart attack
• Have or have ever had a liver disease where your liver function has not returned to normal
• Have porphyria.

Speak to your doctor if you have any questions about the conditions listed above. You should also tell your doctor and take extra care when taking Elleste Duet if you have any of the following, as you may need to see your doctor more often for medical check-ups:

• Fibroids inside your womb
• Endometriosis (growth of the womb lining outside of the womb)
• Endometrial hyperplasia (excessive growth of the womb lining)
• Increased risk of developing thrombosis (blood clots)
• Increased risk of developing oestrogen-sensitive cancers e.g. a strong family history
• High blood pressure
• A liver disorder
• Diabetes
• Gallstones
• Migraines or severe headaches
• Systemic lupus erythematosus (SLE)
• Epilepsy
• Asthma
• Otosclerosis (a disease affecting the eardrum or hearing)

You should stop taking Elleste Duet immediately and consult your doctor if you notice:

• Any of the conditions listed above
• Jaundice (yellowing of the skin or whites of the eyes). This could be a sign of liver disease
• A significant rise in blood pressure, characterised by headaches, tiredness, dizziness
• Migraine-like headaches
• You become pregnant
• Painful swelling of the legs, sudden chest pain or difficulty breathing, which could be signs of a blood clot

HRT that contains a progestogen as well as an oestrogen, such as Elleste Duet, has a reduced risk of endometrial cancer compared to oestrogen-only HRT. However, evidence suggests that HRT containing both oestrogen and progesterone could lead to an increased risk of breast cancer. While taking this medication, it is important to regularly check your breasts for any lumps you can see or feel, dimpling of the skin or changes to the nipple, and speak to your doctor if you are concerned. 

Drug interactions

Before taking Elleste Duet, tell your doctor if you are taking any other medications, including those bought over the counter without a prescription. In particular, the following medicines may interfere with Elleste Duet:

• Epilepsy medications, such as phenobarbital, phenytoin and carbamazepine
• Tuberculosis medications, such as rifampicin and rifabutin
• Medications for HIV infection, such as nevirapine, efavirenz, ritonavir, telaprevir and nelfinavir
• Herbal remedies containing St John’s wort (hypericum perforatum)

Elleste vs. Elleste Duet

Elleste Solo contains only estradiol (oestrogen) and is bioidentical whereas Elleste Duet contains both estradiol and norethisterone. The norethisterone is not bioidentical. Because it does not contain a progestogen, Elleste Solo is only suitable for women who have had a hysterectomy, or who have an intrauterine system (IUS/Mirena coil). 

Elleste Duet vs. Elleste Duet Conti

Elleste Duet Conti provides a constant dose of both oestrogen and progestogen every day, meaning you will not experience a monthly bleed. This is in comparison to Elleste Duet which has 16 days of estradiol only and 12 days of estradiol and norethisterone. Elleste Duet is recommended for women who are still having menstrual periods, and Elleste Duet Conti is more suitable for those who have not experienced a natural period for 12 months or more.

Alternatives to HRT

HRT is widely accepted as the most effective treatment for the symptoms of menopause. Some people may choose a herbal supplement as an alternative, although the effectiveness of these treatments is unknown. It is important to speak to a doctor or pharmacist about the effects of different herbal supplements. Some women do not take any treatment for menopausal symptoms.

Lifestyle changes to improve menopause symptoms

Making certain lifestyle changes can help you to deal with the symptoms of menopause and increase the benefits of treatments such as HRT. The impact of hot flushes and night sweats can be reduced by cutting down on caffeine, alcohol and spicy foods, as well as by avoiding smoking and wearing loose clothing. Exercising regularly can help with stress management whilst simultaneously strengthening your bones and improving your general wellbeing. Increasing your intake of vitamin D, which is vital for absorbing calcium, can also contribute to keeping your bones strong and reducing the chance of developing osteoporosis. For those experiencing vaginal dryness, there are many moisturisers and lubricants available, and a pharmacist will be able to give advice on which is best for you.

Elleste vs. other HRT

There are several different types of HRT that are accessible online from Dr Felix. Trisequens is similar to Elleste, as it is also an oral sequential form of HRT. It differs in that it is triphasic, i.e. contains three different doses of the hormone, rather than two different doses as in Elleste Duet. Sequential HRT is also available in patch form e.g. Evorel Sequi, which may be more suitable for those who suffer side effects from oral preparations. Evorel Sequi contains the same hormones as Elleste Duet – estradiol and norethisterone. 

For women who have stopped having menstrual periods for at least a year, a continuous combined formulation is more suitable, such as Elleste Duet Conti or Kliovance also contain synthetic forms of both oestrogen and progestogen and so are suitable for women who have not had a hysterectomy, or who do not have an intrauterine system (IUS) fitted. 

Another alternative type of HRT is Tibolone, (brand name Livial), which is a type of steroid which works by activating the oestrogen and progestogen receptors. It is a selective steroid that carries a slightly lower risk of breast cancer.

Hormone replacement therapies containing only oestrogen are also available but are only suitable for women who have had a hysterectomy or who have an IUS (Mirena coil) fitted. An IUS will do the job of providing the progesterone needed to counteract the risk of endometrial cancer associated with oestrogen supplements. Oestrogen-only therapies can be purchased in tablet form (Premarin, Elleste Solo) or in the form of patches to be worn on the skin (Elleste Solo MX80, Elleste Solo MX40, Evorel).

Is Elleste Duet bioidentical?

Elleste Duet contains estradiol hemihydrate, a synthetic form of oestrogen, and norethisterone acetate, a synthetic form of progesterone. While the estradiol is bioidentical, norethisterone acetate is not.