Duphaston (dydrogesterone) is a synthetic progestogen specifically engineered to mimic the physiological effects of natural progesterone. It is widely prescribed in gynecological and reproductive medicine for its high selectivity, excellent safety profile, and predictable therapeutic outcomes. Unlike some older progestogens, it is derived from retroprogesterone, offering targeted action with minimal androgenic, glucocorticoid, or anti-mineralocorticoid side effects. Its primary mechanism involves binding to progesterone receptors in the endometrium, ensuring a secretory transformation and providing crucial hormonal support where needed.

Features

• Active ingredient: Dydrogesterone 10 mg
• High selectivity for progesterone receptors
• No androgenic, estrogenic, or corticosteroid-like activity
• Does not inhibit ovulation
• Well-established safety and tolerability profile
• Available in coated tablet form for oral administration

Benefits

• Effectively supports and maintains the luteal phase of the menstrual cycle, reducing the risk of endometrial hyperplasia.
• Provides essential hormonal support for the establishment and maintenance of pregnancy in cases of progesterone deficiency.
• Helps manage conditions like endometriosis and dysfunctional uterine bleeding by regulating endometrial growth.
• Minimizes common progestogenic side effects such as weight gain, acne, or hirsutism due to its non-androgenic nature.
• Allows for predictable withdrawal bleeding, making it useful in both fertility treatments and cycle regulation.
• Does not interfere with normal ovulation, preserving fertility potential when used in appropriate indications.

Common use

Duphaston is primarily indicated in the treatment of disorders related to progesterone deficiency. Its most common applications include luteal phase support in infertility management, treatment of endometriosis, management of dysfunctional uterine bleeding, and secondary amenorrhea. It is also used in hormone replacement therapy (HRT) regimens, combined with estrogen, to protect the endometrium from hyperplasia. Furthermore, it is prescribed for the prevention of miscarriage in women with a documented history of habitual abortion due to luteal insufficiency.

Dosage and direction

The dosage of Duphaston is highly indication-specific and must be individualized under medical supervision.

• For endometriosis: Typically 10 mg two or three times daily from day 5 to day 25 of the cycle, or continuously.
• For dysfunctional bleeding: 10 mg twice daily for 5 to 7 days to stop acute bleeding; for prevention, 10 mg twice daily from day 11 to day 25 of the cycle.
• For infertility due to luteal phase defect: 10 mg daily from day 14 to day 25 of the cycle; treatment should be continued for at least six consecutive cycles.
• For threatened miscarriage: 40 mg initially as a single dose, followed by 10 mg every 8 hours until symptoms resolve.
• For habitual abortion: 10 mg twice daily until the 20th week of pregnancy.

Tablets should be swallowed whole with water, with or without food. Adherence to the prescribed schedule is critical for efficacy.

Precautions

Prior to initiating therapy, a thorough medical evaluation is necessary, particularly focusing on personal or family history of thromboembolic disorders, cardiovascular risk factors, and undiagnosed vaginal bleeding. Liver function should be assessed, as severe hepatic impairment is a contraindication. Patients with a history of depression should be monitored closely, as progestogens can occasionally exacerbate mood disorders. Duphaston is not a contraceptive; additional contraceptive measures are not required when used for indications other than fertility support. In perimenopausal women, a diagnostic curettage should rule out malignancy in cases of abnormal bleeding.

Contraindications

Duphaston is contraindicated in patients with known hypersensitivity to dydrogesterone or any excipient in the formulation. It must not be used in individuals with severe hepatic dysfunction, existing or history of progesterone-dependent neoplasms (e.g., meningioma), undiagnosed vaginal bleeding, or current or history of arterial thromboembolic events (e.g., stroke, myocardial infarction). It is also contraindicated in patients with Dubin-Johnson or Rotor syndromes.

Possible side effect

Duphaston is generally well-tolerated. The most commonly reported side effects are mild and transient, including:

• Headache
• Nausea
• Breast tenderness or discomfort
• Breakthrough bleeding or spotting
• Changes in libido
• Fatigue Rarely, allergic skin reactions (e.g., pruritus, urticaria), jaundice, hemolytic anemia, or edema have been reported. Very rare cases of thromboembolic events have been observed in epidemiological studies, though a causal relationship with dydrogesterone has not been firmly established.

Drug interaction

Dydrogesterone is primarily metabolized by CYP3A4 in the liver. Concomitant use of strong CYP3A4 inducers (e.g., rifampicin, phenobarbital, St. John’s wort) may reduce the plasma concentration and efficacy of Duphaston. Conversely, strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase its levels. Although dydrogesterone has no known effect on the efficacy of oral contraceptives, caution is advised when co-administering with other hormonal therapies. Always inform your physician of all concomitant medications, including over-the-counter drugs and herbal supplements.

Missed dose

If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next dose. In that case, skip the missed dose and resume the regular schedule. Do not double the dose to make up for a missed one. Adherence to the dosing schedule is particularly important in cycle regulation and fertility support to maintain hormonal stability.

Overdose

There have been no reports of acute overdose with Duphaston. Given its favorable safety margin, serious effects are not expected. Symptomatic treatment is recommended. Gastric lavage may be considered if ingestion was recent. There is no specific antidote. Medical attention should be sought if large quantities are ingested, especially in children.

Storage

Store below 30°C (86°F) in the original blister package to protect from light and moisture. Keep out of reach of children. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is for educational purposes only and does not constitute medical advice. Duphaston is a prescription medication and must be used under the direct supervision of a qualified healthcare professional. Never initiate, adjust, or discontinue treatment without consulting your physician. The prescribing information provided here may not be exhaustive; always refer to the local approved product information or summary of product characteristics (SmPC) for complete guidance.

Reviews

Clinical studies and long-term use have established Duphaston as a reliable and effective progestogen. In systematic reviews, it demonstrates efficacy comparable to micronized progesterone, with a superior side effect profile in many patient populations. Physicians appreciate its predictability and patient compliance due to low incidence of androgenic effects. Patients report satisfaction particularly in fertility treatments, where its role in supporting the luteal phase is well-documented. It remains a cornerstone in gynecological therapeutics for its targeted action and safety.