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Off-Label Use — DFSRH MCQ

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HardOff-Label UseDFSRH

A 51-year-old woman with an intact uterus requests treatment for disabling vasomotor menopausal symptoms. She has had no vaginal bleeding for 3 years and has no unexplained bleeding or contraindication to systemic menopausal hormone therapy. She prefers transdermal estradiol. A Levosert 52 mg levonorgestrel intrauterine device was inserted 4 years and 7 months ago, when she was aged 46, for contraception and heavy menstrual bleeding. The device remains correctly positioned, its threads are visible, and her bleeding symptoms remain controlled. She wishes to minimise procedures and asks whether the existing device can provide the progestogen component of hormone therapy. Which is the most appropriate management plan?

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Correct answer: E — Start transdermal estradiol now; use Levosert as off-label endometrial protection and replace it 5 years after insertion.

FSRH supports any 52 mg levonorgestrel intrauterine device, including Levosert, for endometrial protection during systemic oestrogen therapy for up to 5 years. Levosert's current product licence covers contraception and heavy menstrual bleeding, not endometrial protection as part of hormone therapy; this use must therefore be explained and documented as off-label. The 5-year interval is measured from device insertion, not from initiation of oestrogen. She may start estradiol now, but the device should be replaced in 5 months if systemic oestrogen continues. A is incorrect because the age-55 provision concerns contraceptive need, not duration of HRT endometrial protection. B incorrectly extrapolates the 8-year contraceptive duration to endometrial protection. C is unnecessarily restrictive: Mirena has the licensed HRT indication, but FSRH supports any 52 mg device, and specialist guidance supports 5 rather than 4 years. D would provide adequate protection but adds unnecessary systemic progestogen while a suitable 52 mg device remains within the FSRH-supported interval. The distinction between contraceptive duration and endometrial-protection duration is decisive: although this device was inserted after age 45 and could otherwise remain for contraception until age 55, systemic oestrogen requires replacement at 5 years.

Reference: FSRH Guideline: Intrauterine Contraception (March 2023, amended January 2025) — https://www.fsrh.org/Common/Uploaded%20files/documents/fsrh-clinical-guideline-intrauterine-contraception-mar-23-amended.pdf Levosert 20 microgram/24 hours Intrauterine Delivery System: Summary of Product Characteristics (Updated 12 May 2026; text revision 13 April 2026) — https://www.medicines.org.uk/emc/product/1789/smpc