Utrogestan

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Utrogestan on Prescriptsy

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Utrogestan is a licensed medicine containing micronised progesterone, a body-identical hormone that is chemically identical to the progesterone naturally produced by the human ovary.

Utrogestan capsules (100 mg and 200 mg) are prescribed in the United Kingdom for endometrial protection as part of hormone replacement therapy (HRT) in women with an intact uterus, for luteal phase support in assisted reproduction (including IVF), and for certain progesterone-deficiency conditions.

Micronised progesterone has attracted considerable clinical interest because its molecular identity to endogenous progesterone may confer a more favourable safety profile than synthetic progestogens, particularly regarding breast cancer risk and metabolic effects.

Progesterone is essential for reproductive health. It prepares the endometrium for embryo implantation, supports early pregnancy, and opposes the proliferative effect of oestrogen on the uterine lining.

After the menopause, when ovarian progesterone production ceases, women taking oestrogen-only HRT face an increased risk of endometrial hyperplasia and carcinoma unless a progestogen is added.

Utrogestan fulfils this protective role.

This page provides a comprehensive clinical overview of Utrogestan, covering its mechanism of action, dosing for different indications, side effects, safety warnings, and how to obtain a prescription in the UK.

Important safety information about Utrogestan

Before reading further, note the following key safety points about Utrogestan.

• Utrogestan capsules contain peanut oil and soya lecithin. Do not take Utrogestan if you have a peanut or soya allergy.
• Oral Utrogestan causes drowsiness. Take it at bedtime and do not drive or operate machinery if you feel drowsy.
• If you are using Utrogestan as part of HRT, do not skip the progestogen phase, as this removes the endometrial protection provided by progesterone.
• Report any unscheduled vaginal bleeding, breast lumps, or signs of blood clots (leg swelling, sudden breathlessness, chest pain) to your prescriber immediately.

Understanding progesterone and its role

Progesterone is a steroid hormone produced primarily by the corpus luteum in the ovary during the second half (luteal phase) of the menstrual cycle, and by the placenta during pregnancy.

Its principal functions include transforming the oestrogen-primed proliferative endometrium into a secretory endometrium receptive to embryo implantation, maintaining the decidual reaction necessary for early pregnancy, suppressing uterine contractions, and modulating the maternal immune system to tolerate the developing embryo.

After the menopause, ovarian progesterone production ceases.

In women taking oestrogen replacement therapy, the absence of progesterone allows unopposed oestrogenic stimulation of the endometrium, which progressively increases the risk of endometrial hyperplasia (abnormal thickening of the uterine lining) and, ultimately, endometrial carcinoma.

This risk is well-established and was demonstrated in early HRT studies that used oestrogen-only preparations in women with intact uteri.

The addition of a progestogen for at least 10 to 14 days per cycle (in sequential HRT) or continuously (in continuous combined HRT) reduces this risk to levels comparable to or below those of untreated women.

Why micronised progesterone

Historically, synthetic progestogens such as norethisterone, medroxyprogesterone acetate, and dydrogesterone have been used for endometrial protection in HRT.

While effective, synthetic progestogens differ in molecular structure from endogenous progesterone and interact with other steroid receptors (androgen, glucocorticoid, mineralocorticoid), which may contribute to unwanted effects including adverse lipid changes, fluid retention, mood disturbance, and potentially an increased risk of breast cancer with long-term use.

Micronised progesterone, by contrast, is structurally identical to endogenous progesterone and has a more selective receptor-binding profile.

Micronisation (reduction of particle size to 3 to 5 micrometres) improves the oral bioavailability of natural progesterone, which was previously too poorly absorbed from the gastrointestinal tract for reliable oral dosing.

Observational data, including the French E3N cohort study and the KEEPS trial, suggest that micronised progesterone may be associated with a lower risk of breast cancer than synthetic progestogens when used in combined HRT, though large-scale randomised controlled trial data are still awaited.

How Utrogestan works

Mechanism of action

After absorption, micronised progesterone binds to nuclear progesterone receptors (PR-A and PR-B) in target tissues, including the endometrium, myometrium, breast, brain, and bone.

In the endometrium, progesterone receptor activation induces the transformation of the proliferative phase endometrium into a secretory phase endometrium, characterised by glandular coiling, stromal decidualisation, and reduced mitotic activity.

This secretory transformation is essential both for embryo implantation and for preventing the unchecked endometrial proliferation that leads to hyperplasia and carcinoma.

In the brain, progesterone is metabolised to allopregnanolone, a potent positive allosteric modulator of the GABA-A receptor.

Allopregnanolone produces sedative, anxiolytic, and anticonvulsant effects, which account for the drowsiness commonly experienced with oral Utrogestan.

This metabolic pathway is largely bypassed when Utrogestan is administered vaginally, which is why vaginal use produces less sedation.

Pharmacokinetics

Oral administration: After oral ingestion, micronised progesterone is absorbed from the gastrointestinal tract and undergoes extensive first-pass hepatic metabolism.

Peak serum concentrations are reached within 1 to 3 hours. The main metabolites are 20-alpha-hydroxyprogesterone and pregnanediol.

Oral bioavailability is improved by micronisation but remains relatively low (approximately 10%) due to hepatic clearance.

The sedative effects of oral progesterone are dose-related and result from hepatic generation of allopregnanolone.

Vaginal administration: When capsules are inserted vaginally, progesterone is absorbed directly through the vaginal mucosa, achieving high local uterine concentrations (the "uterine first-pass effect") while producing lower systemic levels than oral dosing.

This route avoids significant hepatic first-pass metabolism, resulting in less allopregnanolone production and therefore less sedation.

Vaginal use is the preferred route for luteal phase support in assisted reproduction, where high endometrial progesterone concentrations are desirable.

Clinical evidence and national guidelines

NICE Guideline NG23 (Menopause: diagnosis and management) recommends that women with an intact uterus taking oestrogen HRT should also take a progestogen to protect the endometrium.

The guideline does not currently specify a preference for micronised progesterone over synthetic progestogens for endometrial protection, but it acknowledges that micronised progesterone is associated with the least additional breast cancer risk when used in combined HRT regimens.

The British Menopause Society (BMS) notes that body-identical progesterone (Utrogestan) is increasingly preferred by both clinicians and patients due to its favourable safety profile and tolerability.

The E3N French cohort study (over 80,000 postmenopausal women followed for up to 12 years) found no significant increase in breast cancer risk with oestrogen-micronised progesterone combinations used for up to 5 years, in contrast to a significantly increased risk with oestrogen-synthetic progestogen combinations.

The REPLENISH trial demonstrated effective endometrial protection with micronised progesterone in a continuous combined oral formulation.

For luteal phase support in assisted reproduction, NICE Guideline CG156 (Fertility problems) recommends progesterone supplementation and notes that vaginal micronised progesterone is a widely used and evidence-based option.

Cochrane reviews confirm that vaginal progesterone is as effective as intramuscular progesterone for this indication, with better tolerability.

Uses of Utrogestan

Endometrial protection in HRT

Utrogestan is used alongside oestrogen (either oral estradiol tablets or transdermal oestrogen patches or gel) to provide the progestogen component of HRT in women with an intact uterus.

It can be used in either a sequential regimen (cyclical progesterone for 12 days per 28-day cycle, producing a withdrawal bleed) or a continuous regimen (daily low-dose progesterone, aiming for no bleeding).

Sequential use is more appropriate for perimenopausal women or those in early postmenopause, while continuous use is preferred for women who are well established in postmenopause.

Luteal phase support in assisted reproduction

During IVF and other assisted reproduction procedures, the corpus luteum may not produce sufficient progesterone to support embryo implantation and early pregnancy, particularly when GnRH agonists or antagonists have been used for ovarian stimulation.

Vaginal Utrogestan (typically 200 to 400 mg twice daily) provides exogenous progesterone to maintain the secretory endometrium and support implantation.

Treatment usually continues until 8 to 12 weeks of gestation, when placental progesterone production becomes sufficient.

Other indications

Utrogestan may also be prescribed for progesterone-deficiency states including irregular menstruation and certain cases of premenstrual syndrome, though these are less common indications in UK clinical practice.

Side effects of Utrogestan

Common side effects

Drowsiness and sedation are the most frequently reported effects of oral Utrogestan, resulting from the hepatic conversion of progesterone to allopregnanolone.

Taking the capsule at bedtime minimises daytime impact and may even improve sleep quality. Other common effects include headache, dizziness, nausea, bloating, breast tenderness, and mood changes.

These are typically mild and often settle within the first few weeks of treatment.

Route-specific effects

Oral administration produces more pronounced sedation, dizziness, and occasionally a feeling of intoxication due to higher allopregnanolone levels.

Vaginal administration is associated with local effects including vaginal discharge, mild irritation, and capsule residue.

Systemic side effects are generally milder with vaginal use because systemic progesterone levels are lower.

Less common side effects

Changes in menstrual bleeding pattern (breakthrough bleeding, spotting, or changes in withdrawal bleed timing), changes in libido, acne, fluid retention, weight changes, and allergic skin reactions (rash, urticaria) have been reported.

Cholestatic jaundice and liver function abnormalities are rare but have been observed with progesterone therapy.

Excipient-related risks

Utrogestan capsules contain peanut oil (arachis oil) and soya lecithin.

Patients with known allergy to peanuts or soya must not use this product, as hypersensitivity reactions including anaphylaxis are possible.

This is one of the most important prescribing considerations for Utrogestan and must be confirmed before dispensing.

When to seek medical advice

Contact your GP or NHS 111 if you experience persistent or worsening mood changes, unexplained vaginal bleeding, jaundice (yellowing of the skin or eyes), or any suspected allergic reaction.

Seek emergency medical help (call 999) if you develop symptoms of severe allergic reaction (swelling of the face, throat, or tongue; difficulty breathing), DVT (painful swollen leg), or PE (sudden breathlessness, chest pain).

Report any suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Utrogestan is contraindicated in patients with known allergy to progesterone, peanut, soya, or any excipient in the capsule; undiagnosed vaginal bleeding; known or suspected breast cancer or other progestogen-dependent neoplasia; severe hepatic impairment or active liver disease; acute porphyria; or a history of meningioma (for which progesterone therapy is contraindicated due to the expression of progesterone receptors in meningioma tissue).

Conditions requiring monitoring

Progesterone should be used with caution in patients with a history of depression (progesterone may exacerbate depressive symptoms), diabetes mellitus (progesterone may affect glucose metabolism), mild to moderate hepatic impairment, epilepsy (allopregnanolone has anticonvulsant properties but may interact with existing anticonvulsant therapy), migraine, asthma, or conditions that may be worsened by fluid retention including cardiac or renal disease.

Thromboembolism

When Utrogestan is used as part of combined HRT, the overall thromboembolism risk is related primarily to the oestrogen component, particularly when oestrogen is given orally.

Current evidence does not indicate that micronised progesterone independently increases VTE risk.

However, patients with VTE risk factors should be carefully assessed, and transdermal oestrogen (which does not increase VTE risk) combined with Utrogestan may be the preferred HRT approach.

Driving and machinery

Oral Utrogestan can cause significant drowsiness, which may impair the ability to drive or operate machinery. Take it at bedtime and be aware that residual sedation may occur the following morning, particularly at higher doses. Do not drive if affected.

Pregnancy and breastfeeding

Utrogestan is used during early pregnancy for luteal phase support in assisted reproduction. Its use in this context should be supervised by a fertility specialist.

There is no evidence of teratogenicity with micronised progesterone at recommended doses. Progesterone is present in breast milk at levels consistent with natural postpartum physiology.

The manufacturer advises caution during breastfeeding; discuss with your prescriber.

How to obtain Utrogestan in the UK

Utrogestan is a prescription-only medicine (POM) and can be prescribed by your GP, a menopause specialist, a fertility clinic, or an authorised online prescriber registered with the GPhC and CQC.

A clinical assessment is required to determine the appropriate indication, dose, and route of administration.

Utrogestan is included on the NHS formulary and is available from all UK pharmacies.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Utrogestan in the context of modern HRT

The trend in UK HRT prescribing has shifted towards body-identical hormones in recent years, driven by patient preference and emerging safety data.

A typical body-identical HRT regimen consists of transdermal estradiol (patch or gel) for oestrogen replacement combined with oral or vaginal Utrogestan for endometrial protection.

This combination avoids the first-pass hepatic effects of oral oestrogen (reducing VTE risk) and uses a progestogen with a potentially lower breast cancer risk than synthetic alternatives.

The British Menopause Society and NHS England have acknowledged this prescribing trend, and Utrogestan availability has improved significantly following earlier supply shortages.

It is important to note that body-identical HRT (using regulated, licensed products like Utrogestan) is distinct from compounded "bioidentical" hormones prepared by non-regulated compounding pharmacies.

The latter are not recommended by NICE, BMS, or the MHRA due to lack of quality control, batch consistency, and safety data.

Utrogestan is a licensed medicine subject to full MHRA regulatory oversight.

When to seek urgent medical advice

Call 999 or attend A&E if you experience symptoms of a severe allergic reaction (difficulty breathing, swelling of face or throat), sudden chest pain or breathlessness (possible pulmonary embolism), or painful swelling in one leg (possible deep vein thrombosis).

Contact your GP or NHS 111 for unexplained vaginal bleeding, persistent mood disturbance, jaundice, or any concerning side effects.

Report any suspected adverse reactions to Utrogestan via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Utrogestan 100mg Capsules, Summary of Product Characteristics (EMC)
• Progesterone, British National Formulary (BNF)
• NICE NG23: Menopause: diagnosis and management
• British Menopause Society
• Hormone Replacement Therapy (HRT), NHS
• MHRA Yellow Card Scheme