Provera

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Provera on Prescriptsy

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Provera is a branded prescription medicine containing medroxyprogesterone acetate (MPA), a synthetic progestogen widely used in the United Kingdom for the management of dysfunctional uterine bleeding (DUB), secondary amenorrhoea, endometriosis, and as the progestogen component of combined hormone replacement therapy (HRT).

MPA is one of the most extensively studied progestogens in clinical medicine, with decades of use in both gynaecological practice and menopausal hormone therapy.

Provera tablets are available in 2.5 mg, 5 mg, and 10 mg strengths.

This page provides a comprehensive clinical overview of Provera, including how medroxyprogesterone acetate works, its clinical indications, dosing guidance, side effects, important safety warnings, and how to obtain a prescription in the UK.

It is written for patients who have been prescribed Provera or who wish to understand how this medication is used in gynaecological and menopausal care.

Important safety information about Provera

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

• Do not take Provera if you are pregnant or think you may be pregnant.
• Tell your prescriber if you have a personal or family history of breast cancer, venous thromboembolism, stroke, heart disease, or liver disease.
• When used as part of combined HRT, Provera contributes to the known risks of HRT including a small increased risk of breast cancer and venous thromboembolism. These risks should be discussed with your prescriber.
• Seek immediate medical attention if you experience sudden chest pain, sudden breathlessness, calf pain or swelling, sudden severe headache, or sudden visual disturbance.

What is medroxyprogesterone acetate

Medroxyprogesterone acetate is a synthetic progestogen structurally related to the naturally occurring hormone progesterone.

In the normal menstrual cycle, progesterone is secreted by the corpus luteum after ovulation and plays an essential role in transforming the oestrogen-primed endometrium from a proliferative to a secretory state.

This secretory transformation stabilises the endometrial lining, supports potential embryo implantation, and, if conception does not occur, leads to coordinated withdrawal bleeding (menstruation) when progesterone levels fall.

MPA mimics the effects of natural progesterone on the endometrium but with greater oral bioavailability and a longer duration of action.

It binds to the progesterone receptor and exerts potent progestational effects, including secretory transformation, decidualisation, and atrophy of the endometrium at sufficient doses.

MPA also has weak androgenic activity and minor glucocorticoid activity, which distinguish it from some other synthetic progestogens.

Indications for Provera

Dysfunctional uterine bleeding

Dysfunctional uterine bleeding refers to abnormal uterine bleeding that is not caused by structural pathology (such as fibroids, polyps, or malignancy), pregnancy, or systemic disease.

It is most commonly related to anovulatory cycles, in which the absence of ovulation leads to continuous oestrogen stimulation of the endometrium without the stabilising effect of progesterone.

The resulting endometrium becomes thick, fragile, and prone to irregular, heavy, or prolonged bleeding.

Provera is used to provide the missing progestational stimulus.

By taking MPA for 5 to 10 days during the second half of the cycle, the endometrium is converted to a secretory state and then shed in a predictable withdrawal bleed after the course is completed.

This regimen is typically repeated for 2 to 3 cycles to establish regularity.

Secondary amenorrhoea

Secondary amenorrhoea is the absence of menstruation for 3 or more months in a woman who previously had regular periods (or 6 months in a woman with previously irregular cycles).

It has many potential causes, including hypothalamic dysfunction (often related to stress, weight loss, or excessive exercise), polycystic ovary syndrome (PCOS), hyperprolactinaemia, thyroid disorders, premature ovarian insufficiency, and Asherman syndrome.

After excluding pregnancy and investigating the underlying cause, a progestogen challenge test using Provera may be performed.

If a withdrawal bleed occurs after 5 to 10 days of MPA, this confirms that the endometrium has been exposed to oestrogen and that the outflow tract is patent.

Endometriosis

Endometriosis is a chronic condition in which tissue similar to the endometrium grows outside the uterine cavity, most commonly on the ovaries, fallopian tubes, peritoneum, and bowel.

It causes chronic pelvic pain, dysmenorrhoea, dyspareunia, and can impair fertility.

MPA at higher doses (typically 10 mg three times daily for 90 consecutive days) causes decidualisation and subsequent atrophy of endometriotic implants, reducing pain and disease activity.

Treatment is often combined with other approaches including NSAIDs, GnRH analogues, and surgical excision.

Combined hormone replacement therapy

In postmenopausal women with an intact uterus who are prescribed systemic oestrogen therapy for vasomotor symptoms (hot flushes, night sweats), a progestogen must be added to protect the endometrium from the proliferative effects of unopposed oestrogen.

Unopposed oestrogen increases the risk of endometrial hyperplasia and endometrial carcinoma in a dose-dependent and duration-dependent manner.

By adding MPA either cyclically (for 12 to 14 days of each 28-day cycle in sequential combined HRT) or continuously (daily in continuous combined HRT), the endometrium is maintained in a stable state and the risk of hyperplasia is substantially reduced.

How Provera works: mechanism of action

MPA exerts its effects primarily through binding to the progesterone receptor (PR).

The PR is a nuclear receptor that, upon ligand binding, undergoes conformational change, dimerisation, and translocation to the nucleus, where it modulates the transcription of target genes.

In the endometrium, MPA suppresses oestrogen-induced gene expression, reducing cell proliferation and inducing secretory differentiation. At higher doses, it causes endometrial decidualisation and atrophy.

MPA also suppresses gonadotrophin secretion from the pituitary gland (LH and FSH) at sufficient doses, which can inhibit ovulation and reduce ovarian oestrogen production.

This mechanism is utilised in the treatment of endometriosis and in the contraceptive injection formulation (Depo-Provera), although the oral Provera tablets discussed here are not licensed as a contraceptive.

The androgenic activity of MPA is clinically minor at the doses used for gynaecological indications and HRT, but may contribute to acne, hirsutism, or unfavourable changes in lipid profiles in susceptible women.

The glucocorticoid activity is similarly weak but may become relevant at very high doses.

Clinical evidence

Endometrial protection in HRT

The need for progestogen addition to oestrogen in HRT for women with a uterus is firmly established.

The Million Women Study, the Women's Health Initiative (WHI), and numerous smaller studies have confirmed that combined oestrogen-progestogen HRT substantially reduces the risk of endometrial hyperplasia and carcinoma compared with oestrogen alone.

MPA is the most extensively studied progestogen for this purpose, having been used in the WHI trial alongside conjugated equine oestrogens.

WHI findings

The WHI combination therapy arm (conjugated equine oestrogens 0.625 mg plus MPA 2.5 mg daily) was stopped early after a mean follow-up of 5.2 years due to an excess of breast cancer, coronary heart disease, stroke, and pulmonary embolism in the treatment group compared with placebo.

However, the absolute excess risks were small (approximately 8 additional breast cancers per 10,000 women per year) and must be interpreted in the context of the study population (average age 63 at recruitment, not representative of typical HRT initiators in the UK).

NICE NG23 provides balanced guidance for UK clinicians and patients on the risks and benefits of HRT.

Dosage and administration

The dose and regimen of Provera depend on the clinical indication.

For dysfunctional uterine bleeding, 2.5 to 10 mg daily for 5 to 10 days is given in the second half of the cycle and repeated for 2 to 3 cycles.

For secondary amenorrhoea, 2.5 to 10 mg daily for 5 to 10 days is given, with a withdrawal bleed expected 3 to 7 days after completing the course.

For endometriosis, 10 mg three times daily for 90 consecutive days is a common regimen, though dosing may be adjusted under specialist supervision.

For combined HRT, the dose depends on the type of regimen.

In sequential combined HRT (suitable for perimenopausal women), MPA 10 mg daily is added for 12 to 14 days of each 28-day oestrogen cycle.

In continuous combined HRT (suitable for women who are at least 12 months postmenopausal), MPA 2.5 to 5 mg daily is taken every day alongside oestrogen.

Continuous combined regimens aim to produce an atrophic endometrium and avoid scheduled withdrawal bleeds.

Provera tablets should be swallowed whole with water and may be taken with or without food.

If a dose is missed, take it as soon as remembered unless the next dose is due soon. Do not take a double dose.

Follow your prescriber's instructions carefully regarding the timing and duration of treatment.

Side effects of Provera

Common side effects

The most frequently reported side effects of Provera include menstrual irregularities (breakthrough bleeding, spotting, and changes in flow), headache, nausea, abdominal discomfort, breast tenderness, mood changes (including low mood and irritability), weight changes, fluid retention, dizziness, and fatigue.

These effects are usually mild and may diminish with continued use.

If breakthrough bleeding persists beyond the first 3 months of HRT, consult your prescriber, as further investigation may be required to exclude endometrial pathology.

Less common side effects

Acne, hirsutism, changes in libido, insomnia, and skin rash may occur. Cholestatic jaundice and abnormal liver function tests have been reported rarely. Alopecia, nervousness, and changes in cervical secretion are uncommon.

Serious risks associated with HRT use

When Provera is used as part of combined HRT, patients should be aware of the established risks of combined oestrogen-progestogen therapy.

These include a small increased risk of breast cancer (approximately 8 additional cases per 10,000 women per year after 5 years of use), venous thromboembolism (DVT and PE, approximately 7 additional cases per 10,000 women per year), ischaemic stroke, and a possible small increase in coronary heart disease risk.

These risks are influenced by the type, dose, and route of oestrogen, the type of progestogen, the duration of use, the patient's age, and individual risk factors.

When to seek medical advice

Seek emergency medical attention if you develop sudden severe headache, sudden visual disturbance (blurred vision or loss of vision), sudden chest pain or breathlessness (possible PE), calf pain, redness, or swelling (possible DVT), or signs of a severe allergic reaction (facial swelling, throat tightness, difficulty breathing).

Contact your GP promptly for persistent or heavy irregular bleeding, breast lumps, jaundice (yellowing of the skin or eyes), persistent low mood, or any other troublesome symptoms.

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

Warnings and precautions

Contraindications

Provera is contraindicated in known or suspected pregnancy, undiagnosed vaginal bleeding, known or suspected breast cancer, known or suspected hormone-dependent malignancy, active or recent venous thromboembolism (DVT or PE), active or recent arterial thromboembolic disease (stroke, MI), severe hepatic impairment or active liver disease, porphyria, and known hypersensitivity to MPA or any excipient.

Breast cancer risk

The increased risk of breast cancer associated with combined HRT is well established.

The risk begins to increase after approximately 3 to 5 years of use and returns to baseline approximately 5 years after stopping.

Women should undergo regular breast screening in line with the NHS Breast Screening Programme (mammography every 3 years for women aged 50 to 71).

MPA-containing combined HRT may increase mammographic density, potentially reducing the sensitivity of screening. Any breast lumps or changes should be reported to your GP promptly.

Venous thromboembolism

Combined HRT is associated with a 1.3 to 3 fold increased risk of VTE compared with non-use.

Risk factors include personal or family history of VTE, obesity (BMI above 30), immobility, surgery, and thrombophilia.

Transdermal oestrogen with oral progestogen may carry a lower VTE risk than oral oestrogen, and your prescriber may consider this option if you have VTE risk factors.

If you develop symptoms of DVT (calf pain, redness, warmth, swelling) or PE (sudden chest pain, breathlessness, coughing blood), seek emergency medical attention.

Cardiovascular disease and stroke

The WHI study found a small increased risk of coronary events and ischaemic stroke with combined HRT.

Current evidence suggests that the cardiovascular risk profile of HRT depends on the age of initiation and the time since menopause.

Women who start HRT within 10 years of menopause onset and before age 60 generally have a lower cardiovascular risk profile than those who start later.

Individualised risk assessment is recommended.

Liver disease

Provera is metabolised by the liver.

It should not be used in women with active liver disease, severe hepatic impairment, or a history of cholestatic jaundice related to previous progestogen use.

Liver function tests should be monitored if there is any clinical suspicion of hepatic dysfunction during treatment.

Other precautions

Use Provera with caution in women with epilepsy, migraine (particularly migraine with aura), asthma, diabetes mellitus, hypertension, heart failure, or renal impairment, as fluid retention may worsen these conditions.

Women with a history of depression should be monitored during treatment, as progestogens may exacerbate depressive symptoms.

How to get a Provera prescription in the UK

Provera is a prescription-only medicine (POM) in the UK.

It can be prescribed by your GP, gynaecologist, menopause specialist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

Before prescribing, your clinician will take a full medical and gynaecological history, perform a blood pressure check and breast examination where appropriate, and arrange any necessary investigations (such as pelvic ultrasound, endometrial biopsy, or blood tests) to establish the diagnosis and exclude malignancy.

Generic medroxyprogesterone acetate tablets are available and are bioequivalent to Provera. Your prescriber or pharmacist may offer a generic alternative.

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

Living with gynaecological conditions: practical advice

If you are taking Provera for dysfunctional uterine bleeding, keeping a menstrual diary can help track your symptoms, bleeding patterns, and response to treatment.

Share this diary with your GP at follow-up appointments.

If you are taking Provera as part of HRT, attend your annual HRT review to reassess the benefits and risks of continued treatment.

Report any new symptoms, changes in bleeding pattern, or breast changes to your prescriber.

Maintain a healthy lifestyle including regular exercise, a balanced diet, adequate calcium and vitamin D intake for bone health, and attendance at routine NHS screening programmes (cervical screening, breast screening, and bowel screening where applicable).

When to seek urgent medical advice

Call 999 or attend A&E if you experience sudden severe chest pain, sudden difficulty breathing, sudden one-sided weakness or difficulty speaking (possible stroke), sudden severe headache unlike any previous headache, sudden visual loss, or severe abdominal pain.

Contact your GP or NHS 111 for persistent heavy or irregular bleeding, breast lumps or skin changes, jaundice, persistent mood disturbance, or any other concerns about your medication.

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

Sources

• Provera 10 mg tablets, Summary of Product Characteristics (EMC)
• Medroxyprogesterone acetate, British National Formulary (BNF)
• NICE NG23: Menopause, diagnosis and management
• NICE CKS: Menorrhagia
• Hormone replacement therapy (HRT), NHS
• MHRA Yellow Card Scheme