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FSRH CEU Statement: New manufacturer/MHRA advice regarding nomegestrol acetate – how does this affect prescribing of Zoely®? (April 2023)

File size: 497kb | Date: 13 April 2023 | Clinical Statements - PDF

Theramex, in agreement with the MHRA, has issued a direct healthcare professional communications (DHPC) letter relating to prescribing of Zoely®, a combined oral contraceptive containing estradiol in combination with 2.5mg of the progestogen nomegestrol acetate (NOMAC).

The guidance is a response to evidence indicating an association between use of preparations containing nomegestrol acetate at higher doses than in Zoely (3.75mg-5mg) and increased risk of intracranial meningioma.

There is not evidence relating directly to use of Zoely itself.

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FSRH response to new study using a mathematical model to inform dose and regimen of exogenous hormones (April 2023)

File size: 347kb | Date: 13 April 2023 | Clinical Statements - PDF

A new mathematical model suggests that effective suppression of ovulation for contraception could be achieved using lower doses of progestogen and estrogen than those currently used in hormonal contraceptives. A paper published today in PLOS Computational Biology describes the model and its findings. The authors highlight that lower exposure to exogenous hormones could reduce associated health risks and side effects. The model could be used to inform dose and regimen of exogenous hormones to be investigated by future clinical trials seeking to find new options for safe, effective and acceptable contraception. Clinical trials would be required to investigate what outcomes, with such regimens, were found in practice.

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FSRH New Product Review: Intrauterine Ball (IUBTM) Ballerine® MIDI (February 2019) (Updated April 2023)

File size: 425kb | Date: 11 April 2023 | New Product Reviews - PDF

Manufactured by OCON Medical Ltd, the Intrauterine Ball (IUB™) SCu300B MIDI is a copper intrauterine device (Cu-IUD) comprised of copper beads with a total exposed copper surface of 300mm² strung on a flexible Nitinol (nickel/titanium alloy), PET-coated frame. Once the IUB is released from the 3.2mm diameter insertion tube into the uterus it coils into a spherical shape measuring 15mm in diameter. Download the product review in full here.

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FSRH CEU Guidance: Switching or Starting Methods of Contraception (April 2023)

File size: 964kb | Date: 3 April 2023 | Current Clinical Guidance - PDF

This quick guide advises on effective starting or switching between contraceptive methods to reduce the risk of unplanned pregnancy. It summarises information from existing FSRH guidance documents. This guide should be used in conjunction with clinical judgment in individual situations. Published April 2023. 

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Nomegestrol acetate (Zoely): Measures to minimise the risk of meningioma

File size: 257kb | Date: 24 March 2023 | Useful Resources - PDF

Theramex Ireland Limited in agreement with the Medicines and Healthcare products Regulatory Agency (MHRA) would like to provide you with information to minimise the risk of meningioma after the use of nomegestrol acetate or chlormadinone acetate containing products.

Zoely contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate)

Should you have any questions regarding the use of nomegestrol-containing products, please contact Theramex Ireland Limited at medinfo.uk@theramex.com

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APPG SACHA Study meeting summary

File size: 203kb | Date: 23 March 2023 | FSRH Policy and External Affairs - PDF

This document is a summary of the APPG SRH's meeting to discuss the SACHA Study findings on 7 March 2023.