Leuprolide Acetate 3.75 mg Injection

Leuprolide Acetate 3.75 mg is a monthly depot injection used to treat endometriosis, uterine fibroids, and central precocious puberty, and is used in certain IVF protocols. It is the generic equivalent of Lupron Depot 3.75 mg (USA) and Prostap SR (UK). One injection per month suppresses oestrogen production for sustained hormonal control.

Product Information

What is Leuprolide Acetate 3.75 mg Injection?

Leuprolide Acetate 3.75 mg is the monthly depot formulation of leuprolide acetate — a synthetic GnRH agonist used primarily in women to manage endometriosis and uterine fibroids. It is the generic equivalent of Lupron Depot 3.75 mg, one of the most prescribed hormonal injections for gynaecological conditions. Each injection provides continuous oestrogen suppression for 28 days, reducing pelvic pain, lesion size, and fibroid volume over a treatment course of up to six months.

In the UK, the equivalent branded product is Prostap SR (Takeda). In India, widely prescribed brands include Lupride Depot (Sun Pharma) and Luprodex (Bharat Serums and Vaccines). All contain the same active ingredient — leuprorelin acetate — at the same monthly dose.

Uses of Leuprolide Acetate 3.75 mg Injection

Leuprolide 3.75 mg is indicated for endometriosis — reducing pelvic pain, dysmenorrhoea, and the size of endometriotic lesions. It is also prescribed before surgery in women with anaemia caused by uterine fibroids, where it reduces fibroid volume and improves haemoglobin levels ahead of the procedure. In children, the monthly dose is used to suppress early-onset puberty in central precocious puberty.

Off-label uses include the IVF long protocol, where monthly leuprolide suppresses natural hormone activity before controlled ovarian stimulation begins, and in premenopausal women with hormone receptor-positive breast cancer as ovarian suppression therapy alongside tamoxifen or an aromatase inhibitor.

How Does Leuprolide Acetate 3.75 mg Work?

After the first injection, leuprolide causes a brief initial surge in LH and FSH — temporarily raising oestrogen levels for one to two weeks. This is followed by sustained suppression of the hypothalamic-pituitary-gonadal axis, reducing oestrogen to post-menopausal levels. This removes the hormonal environment that drives endometriosis lesion growth, fibroid enlargement, and early pubertal development. The depot microsphere formulation ensures gradual, controlled release of leuprolide acetate over the full 28-day dosing interval.

Benefits of Treatment

Leuprolide 3.75 mg is clinically proven to reduce endometriosis-related pain in the majority of patients within the first two to three months of treatment. In fibroid management, it significantly reduces uterine volume and corrects anaemia before surgery, lowering intraoperative risk. The monthly injection format allows dose flexibility and clinical monitoring at regular intervals — particularly important in gynaecological and fertility treatment settings where treatment response needs to be assessed frequently.

Frequently Asked Questions

What is Leuprolide Acetate 3.75 mg used for?

Leuprolide 3.75 mg is used to treat endometriosis, uterine fibroids, and central precocious puberty. It is also used in IVF long protocols and in premenopausal women with hormone receptor-positive breast cancer. It works by suppressing oestrogen production, reducing symptoms and disease progression driven by female hormones.

Is Leuprolide Acetate 3.75 mg generic for Lupron Depot?

Yes. Leuprolide Acetate 3.75 mg is the generic equivalent of Lupron Depot 3.75 mg by AbbVie (USA). In the UK, the closest equivalent is Prostap SR by Takeda. In India, Lupride Depot by Sun Pharma and Luprodex by Bharat Serums and Vaccines are the most commonly prescribed branded versions.

How often is the 3.75 mg injection given?

Once every 28 days (monthly). It is given as an intramuscular depot injection by a healthcare professional. Treatment for endometriosis is typically six months; for fibroids, three months is the usual preoperative course. Duration is adjusted based on clinical response and bone density considerations.

What is the difference between Leuprolide 3.75 mg and 11.25 mg?

Both treat the same conditions — endometriosis, fibroids, and central precocious puberty. The 3.75 mg dose is given monthly; the 11.25 mg dose is given every three months. The three-month formulation offers fewer injections per year, while the monthly formulation allows closer clinical monitoring and easier dose adjustment if needed.

Is Leuprolide 3.75 mg used in IVF?

Yes. In the IVF long protocol, Leuprolide 3.75 mg is used to suppress natural hormonal activity before controlled ovarian stimulation. It prevents premature ovulation and allows the fertility specialist to control the timing of egg retrieval more precisely. The dose and protocol vary between fertility clinics.

Can Leuprolide 3.75 mg shrink uterine fibroids?

Yes. Monthly Leuprolide 3.75 mg reduces uterine and fibroid volume by lowering oestrogen levels. It is typically prescribed for three months before fibroid surgery to reduce bleeding risk, correct anaemia, and make the procedure technically easier. It is not a permanent treatment for fibroids — they may regrow after the injection is stopped.

Is it the same as Prostap SR in the UK?

Prostap SR by Takeda (UK) contains leuprorelin acetate — the INN for leuprolide acetate — at the same monthly dose and for the same indications. It is the most widely prescribed equivalent in the UK for endometriosis and fibroid management. Prostap SR DCS is the prefilled syringe version available through NHS prescribing.

What are the common side effects?

Common side effects include hot flushes, night sweats, vaginal dryness, reduced libido, mood changes, and headaches. Bone density loss can occur with prolonged use — for this reason, treatment is generally limited to six months unless add-back therapy with norethindrone acetate is prescribed alongside it. Most side effects resolve within a few months of stopping the injection.

What is add-back therapy and when is it used?

Add-back therapy involves taking a low dose of a progestogen — usually norethindrone acetate 5 mg daily — alongside Leuprolide to reduce the bone density loss and menopausal symptoms caused by oestrogen suppression. It is recommended when treatment extends beyond six months or when side effects significantly affect quality of life, and does not reduce the effectiveness of the leuprolide.

How does Leuprolide 3.75 mg compare to Goserelin (Zoladex) for endometriosis?

Both are GnRH agonists with comparable clinical outcomes for endometriosis. Goserelin (Zoladex 3.6 mg) is given monthly as a subcutaneous implant; Leuprolide 3.75 mg is given as an intramuscular depot injection. Efficacy in pain reduction and lesion size is similar. Choice depends on prescriber preference, patient tolerance, and local formulary.

Regional Brands

Medical Disclaimer

This content is for general reference only and does not constitute medical advice. Leuprolide Acetate is a prescription-only medicine. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.

Reviewed by a Licensed Pharmacist | July 2026