Estradiol Supplementation for Pubertal Induction in Girls M14

Information for parents, carers and young women

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Estradiol Patch (281kB)

What is estradiol and what is it used for?

Estradiol is a form of the female hormone estrogen which is produced normally in the ovaries. Estradiol supplementation is used to induce puberty in girls with primary or secondary ovarian insufficiency or delayed puberty. In those with an intact uterus, a progestogen is added after a certain time frame to allow controlled endometrial shedding (also known as a period). The addition of progestogen reduces the estrogen-induced risk of endometrial hyperplasia in these young women who have an intact uterus.

What is estradiol available as?

Estradiol is available as a transdermal patch at various strengths:

• ‘25’ releases 25microgram of estradiol per day
• ‘50’ releases 50microgram of estradiol per day
• ‘75’ releases 75microgram of estradiol per day
• ‘100’ releases 100microgram of estradiol per day

Estradiol is also available in an oral tablet form. Your doctor will work out a specific dose individualised for your child, with your child’s choice in mind.

(Please note, some estradiol preparations also contain progestogen in the packaging for cycling use. Please read the pharmacy label and manufacturer’s patient information leaflet on how to take combination (estradiol + progestogen) products correctly. The rest of this leaflet refers to estradiol only products).

Estradiol comes in the form of a patch which is applied directly to the skin. It then passes slowly into the bloodstream through the skin. At Alder Hey we stock two strengths of the medication. 

Speak to your doctor before using estradiol if your child:

• If your child is allergic to estradiol or any of the other ingredients listed.
• If your child has a blood problem known as porphyria.
• If your child has or has previously had a blood clot or blood clotting disorder.
• If your child has or has previously had issues with their liver.
• If your child has high blood pressure, diabetes, migraines or severe headaches, epilepsy or asthma.
• If you have a family history of estrogen-dependent tumours e.g. breast cancer

How should I give estradiol and when should I give it?

Your child will usually start on a low dose and increase the dose every few months.

Tablets

ch has been cut, the remaining section of the patch should be returned to its cover and stored in the fridge. Discard this after one week.

Transdermal patch

Estradiol transdermal patches are self-adhesive and applied to the skin surface.

How to apply the patch

The patch should be applied to the skin as soon as it is removed from the wrapper. Recommended application sites are on clean, dry, hairless, healthy, intact skin and each application should be made to a slightly different area of skin on the trunk below waistline (such as the thigh or bottom). It can be worn under loose areas of clothing.

Step 1 How to open and peel the estradiol patch
Use the notches as a guide and tear along two edges of the pouch. Remove the patch. With the protective backing facing you, bend and peel off half of the backing strip. Be careful not to touch the sticky side.

Step 2: How to apply and press the estradiol patch
Apply the open half of the patch to your skin. Remove the remaining backing strip and press down the rest of the patch. Press the patch with the palm of your hand to make sure it is firmly stuck.
If you are cutting the patch, you may have to use additional surgical tape to secure the patch in place.

How to cut the patch if necessary

To obtain half (1/2) of a patch: Cut the patch diagonally from
end to end.

To obtain quarter (1/4) of a patch: Cut the patch in half and
halve again so that the patches are equal either side

To obtain an eighth (1/8) of a patch: Cut the patch to a quarter
and halve again so that the patches are equal either side.

To obtain a sixteenth (1/16) of a patch: Cut the patch to an eighth
and halve again so that the patches are equal either side

Apply the patch fraction as per step 2 above.

Unused patch fractions may be stored in their packaging in the fridge for up to one week.

The dotted lines in the diagrams below show where to cut the patch.

Do not

• Do not apply the patch on the same area of skin twice in a row.
• Do not apply on or near the breasts.
• Do not put the patch on top of cuts, spots or anywhere the skin is irritated.
• Do not use cream, moisturiser or talcum powder on the area of skin before applying the patch.
• Do not wear the patch under tight clothing, elasticated areas or a tight waistband

Everyday activities

Patients using estradiol patches can:

• have a bath or shower as normal. Care should be taken not to scrub too hard on and around the patch as this can loosen the edges.
• Go swimming. The patch will not be affected.
• Exercise and play sports.
• You can go out in the sun, however, keep the patch covered with clothing, out of direct sunlight

Changing the estradiol patches

Estradiol patches need to be changed regularly, how often they require changing may depend on the brand of patch your child has been provided. Please read your doctors’ instructions and the pharmacy label to find out how often you need to change the patch.

Change your patch on the same day(s) each week. Ensure the previous patch is removed before administering a new one

How to remove the patch

1. Peel an edge of the patch smoothly away from the skin.
2. Fold the used estradiol patch in half, so that the sticky side sticks to itself.
3. Dispose of the estradiol patch with the household rubbish, safely out of the reach of children and pets.
4. Do not flush the used patches down the toilet.

Baby oil can be used to help remove any gum/glue which may remain on their skin after patch removal.

When should estradiol start working?

This medication will work gradually as estrogen is replaced into the body. Before stopping estradiol patches for any reason, the prescribing doctor should be contacted

Are there any possible side effects?

Like any medicine, estradiol may have side effects but not everybody gets them.
Some reported side effects with estradiol are:

There are risks of taking hormone replacement therapy in post-menopausal women, these risks do not apply to girls and women under the age of 50, this treatment is just replacing the hormones that the body should normally be making at this age.

If you are worried about any side effects before starting treatment, please contact your child’s doctor to discuss further. If your child experiences any side effects, talk to your doctor or pharmacist.

There may, sometimes, be other side-effects that are not listed above. If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Stop taking estradiol and see a doctor immediately if you notice any of the following:

• yellowing of your skin or the whites of your child’s eyes (jaundice). These may be signs of a liver disease
• swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema
• a large rise in your child’s blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
• if your child becomes pregnant
• if you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing

Can other medicines be taken at the same time as estradiol?

Other medicines can affect the way estradiol works in the body, and estradiol can also affect how other medications work. Tell your doctor/pharmacist if your child is taking any other medications including over the counter medicines.

Where should I keep this medicine?

• Store this medicine in a cool dry place.
• Do not store above 25°C.
• Cut patches should be stored in the fridge for up to 1 week.
• Keep the estradiol patches in the original packaging.
• Discard the medication after the expiry date.
• Keep out of reach and sight of children.

How do I obtain further supplies of estradiol?

Further supplies of estradiol are available via Alder Hey Pharmacy.

General advice about medicines

• Never give this medication to anyone else, even if their condition appears to be the same, as this could do harm.
• If you think someone else may have taken the medicine by accident, contact your doctor straight away.
• Make sure that you always have enough medicine.  Order a new prescription at least two weeks before you will run out.
• Make sure that the medicine you have at home has not reached the ‘best before’ or ‘use by’ date on the packaging.  Give old medicines to your pharmacist to dispose of.
• This leaflet should be read with any manufacturers’ patient information

References

1. Carina Ankarberg-Lindgren et al. Physiological Estrogen Replacement Therapy for Puberty Induction in Girls: A Clinical Observational Study. HORMONE RESEARCH IN PAEDIATRICS2014; 81 p239-244
2. Guidance Statement: Hormone Supplementation for Pubertal Induction In Girls. BSPED working group; 30 September 2016; reviewed June 2022
3. Summary of Product Characteristics, Evorel Patches, Theramex UK Ltd. Last updated June 2023
4. Summary of Product Characteristics, Elleste Solo Tablets, Mylan. Last updated August 2023

This leaflet only gives general information. You must always discuss the individual treatment of your child with the appropriate member of staff. Do not rely on this leaflet alone for information about your child’s treatment.

This information can be made available in other languages and formats if requested.

PIAG M14