Generic Dydrogesterone ( Dydrogesterone )

Buy Generic Dydrogesterone (Dydrogesterone) without prescription in Canada

In our Canadian pharmacy, you can buy Dydrogesterone without a prescription, with delivery across Canada within 5‑14 days. Discreet and anonymous packaging.

Dydrogesterone is an orally active synthetic progestogen with a molecular structure closely related to natural progesterone. Unlike many synthetic progestins, it does not possess androgenic, estrogenic, anabolic, thermogenic, or corticoid activity, and it does not suppress ovulation at standard therapeutic doses. It is used for a variety of gynaecological conditions where progesterone deficiency is a contributing factor, including menstrual disorders, endometriosis, premenstrual syndrome, threatened or habitual miscarriage related to luteal phase insufficiency, and infertility due to luteal phase deficiency. As part of menopausal hormone replacement therapy (HRT), it protects the endometrium from estrogen‑induced hyperplasia when combined with an estrogen.

Usual adult dose: Dosing depends on the condition. For luteal phase insufficiency (infertility or premenstrual syndrome): 10 mg taken once or twice daily, usually from day 14 to day 25 of the menstrual cycle. For endometriosis: 10 mg two or three times daily, continuously or cyclically. For threatened miscarriage: 40 mg as an initial dose, followed by 10 mg every 8 hours until symptoms subside; treatment should be tapered gradually. For habitual miscarriage: 10 mg twice daily until the 20th week of pregnancy. For secondary amenorrhoea (in combination with an estrogen): 10 mg twice daily for the last 12‑14 days of the estrogen cycle. For HRT (endometrial protection): 10 mg once or twice daily for 12‑14 days each month, in sequence with continuous estrogen. The tablet should be swallowed with water and may be taken with or without food.

Dosage form: Oral tablet: 10 mg of dydrogesterone. The tablet is typically white, round, and scored.

Onset of action: Dydrogesterone is rapidly absorbed, with peak plasma concentrations reached within 0.5–2.5 hours after an oral dose. Endometrial secretory transformation occurs over several days of progestogen exposure. For threatened miscarriage, the utero‑relaxant effect begins shortly after the first dose, and symptom resolution is usually seen within days.

Duration of action: The elimination half‑life of dydrogesterone is approximately 5–7 hours, and that of its main active metabolite, 20α‑dihydrodydrogesterone (DHD), is about 14–17 hours. Clinical effects are maintained with twice‑daily or thrice‑daily dosing as prescribed. The endometrial protective effect lasts as long as the progestin is administered cyclically each month.

Alcohol recommendation: Alcohol consumption should be limited during treatment with Dydrogesterone. Heavy alcohol intake may impair liver function and can interfere with the metabolism of the hormone, potentially reducing its efficacy. Moderate consumption is generally acceptable, but women using dydrogesterone for fertility or pregnancy support should avoid alcohol altogether.

Most common side effects: Headache, nausea, dizziness, breast tenderness, spotting or breakthrough bleeding, and mood changes. These effects are generally mild and transient. Unlike some synthetic progestins, dydrogesterone is well tolerated and has a low incidence of androgenic side effects such as acne or hirsutism. Rare but serious adverse effects include depression, cholestatic jaundice, and allergic reactions. When used in early pregnancy, dydrogesterone has a well‑established safety profile and does not appear to increase the risk of congenital malformations.

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General Information about Dydrogesterone

• INN (International Nonproprietary Name): Dydrogesterone
• Brand names available in Canada: The brand name Duphaston® (Abbott Laboratories) was withdrawn from the Canadian market in 2020 and is no longer available. No generic dydrogesterone products are currently marketed in Canada. Dydrogesterone is, however, widely available internationally under the brand name Duphaston and as a generic in many countries. Our pharmacy supplies internationally sourced dydrogesterone tablets through the international supply chain for personal importation.
• ATC code: G03DB01 (progestogens, pregnadiene derivatives).
• Dosage forms and strengths: Oral tablets: 10 mg of dydrogesterone. The tablet is typically white, round, and scored to allow dose adjustment.
• Manufacturers in Canada: None. Dydrogesterone is not manufactured in Canada. Internationally, Abbott Healthcare and various generic companies manufacture the product. Our pharmacy obtains it via the international supply chain for personal use.
• Registration status in Canada: Not marketed. The original brand Duphaston was approved by Health Canada (DIN 00406340) but was discontinued in 2020 for commercial reasons. The active ingredient dydrogesterone is not currently listed in the Drug Product Database as a marketed product. The medication is imported under a valid prescription for personal use.
• OTC / Rx classification: Prescription only (Rx). A valid prescription from a licensed Canadian healthcare professional is required.

Mechanism of Action and Pharmacology

Dydrogesterone is a stereoisomer of progesterone that has been altered at the 6 and 7 positions of the steroid ring (a retro‑progesterone). This structural change gives it a unique pharmacological profile: it binds selectively to the progesterone receptor and exerts a potent progestational effect on the endometrium, but unlike many other synthetic progestins, it does not bind to androgen, estrogen, glucocorticoid, or mineralocorticoid receptors. As a result, it lacks the androgenic side effects (acne, hirsutism, adverse changes in lipid profiles) that can occur with progestins derived from 19‑nortestosterone. In the estrogen‑primed endometrium, dydrogesterone induces full secretory transformation, resulting in predictable withdrawal bleeding and effective protection against estrogen‑induced hyperplasia. In pregnancy, dydrogesterone supports the decidualisation of the endometrium, reduces uterine contractility, and has an immunomodulatory effect at the maternal‑fetal interface, which may help maintain early pregnancy.

After oral administration, dydrogesterone is rapidly absorbed, with peak plasma concentrations of the parent drug reached within 0.5–2.5 hours. It is extensively metabolised in the liver to its principal active metabolite, 20α‑dihydrodydrogesterone (DHD), which is also a potent, selective progestogen. The elimination half‑life of dydrogesterone is about 5–7 hours, and that of DHD is approximately 14–17 hours. Metabolites are excreted predominantly in the urine as glucuronide conjugates. The drug does not accumulate significantly with repeated dosing. The rapid metabolism and lack of active metabolites with estrogenic or androgenic activity contribute to its favourable side‑effect profile.

Indications

• Luteal phase insufficiency: Treatment of infertility due to inadequate progesterone production in the luteal phase. Also used for premenstrual syndrome and irregular cycles associated with luteal phase defects.
• Threatened miscarriage: Management of early pregnancy bleeding in women with proven low progesterone or a history of recurrent miscarriage linked to luteal phase deficiency.
• Habitual (recurrent) miscarriage: Prevention of pregnancy loss in women with documented luteal phase insufficiency and a history of recurrent spontaneous abortion.
• Endometriosis: Symptomatic management of pain, dysmenorrhoea, and pelvic discomfort associated with endometriosis, by inducing a secretory and then atrophic endometrial response.
• Secondary amenorrhoea: In combination with an estrogen, to induce withdrawal bleeding and confirm an intact hypothalamic‑pituitary‑ovarian axis.
• Dysfunctional uterine bleeding: For the regulation of menstrual cycles in anovulatory bleeding of non‑organic origin.
• Endometrial protection in HRT: To counteract the proliferative effect of estrogen on the endometrium in postmenopausal women with an intact uterus receiving hormone replacement therapy.
• Not indicated for use in children or in men.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Dydrogesterone is specifically indicated for threatened and habitual miscarriage during early pregnancy, and extensive clinical experience has not shown an increased risk of congenital malformations or fetal harm. However, use after the 20th week of pregnancy is less well studied and should be based on a careful individual risk‑benefit assessment. When used for other indications (e.g., menstrual disorders, HRT), pregnancy should be excluded before starting therapy.
• Breastfeeding: Dydrogesterone is excreted in breast milk in small amounts. No adverse effects on the nursing infant have been reported, but it should be used during breastfeeding only if clearly needed. The lowest effective dose should be used.
• Paediatrics (< menarche): Safety and efficacy have not been established in children before menarche. Use is not recommended outside of specialist paediatric gynaecological care.
• Elderly: In postmenopausal women using combined HRT, the risks of venous thromboembolism, stroke, breast cancer, and probable dementia are increased. HRT should be used at the lowest effective doses for the shortest possible duration, and the need for continued therapy should be reassessed annually.
• Undiagnosed abnormal vaginal bleeding: Any unexplained uterine bleeding must be investigated before initiating dydrogesterone to exclude organic pathology, including endometrial hyperplasia or carcinoma.
• Liver disease: Dydrogesterone is metabolised in the liver and is contraindicated in patients with severe hepatic impairment, active liver disease, or a history of cholestatic jaundice of pregnancy. Use with caution in mild to moderate hepatic impairment, and monitor liver function periodically.
• Venous thromboembolism (VTE): Combined HRT containing an estrogen and a progestin increases the risk of deep vein thrombosis and pulmonary embolism. However, observational data suggest that dydrogesterone combined with oral or transdermal estrogen may carry a lower VTE risk than some other synthetic progestins. Nevertheless, standard precautions apply: HRT should be discontinued at least 4 weeks before major elective surgery and during prolonged immobilisation.
• Breast cancer: Combined HRT is associated with an increased risk of breast cancer, which increases with duration of use. Studies suggest that dydrogesterone combined with estrogen may confer a lower additional risk of breast cancer compared with other progestins. All women should undergo regular breast examinations and mammography.
• Depression: Progestogens can cause or exacerbate depression. Women with a history of depression should be monitored closely, and the medication should be discontinued if severe depression recurs.
• Allergy: Do not take Dydrogesterone if you have a known hypersensitivity to dydrogesterone or any excipient in the tablet.

Driving and alcohol

Dydrogesterone is not known to impair the ability to drive or operate machinery. Some patients may experience dizziness or fatigue, particularly at the start of therapy or at higher doses. Patients should ensure they are not adversely affected before driving. Alcohol consumption should be limited during treatment. Heavy alcohol intake may increase the risk of liver stress and can worsen mood disturbances. In women using dydrogesterone for fertility or early pregnancy support, alcohol should be completely avoided.

Dosage Instructions

• Luteal phase insufficiency (infertility, PMS): 10 mg once or twice daily, starting on the 14th day of the menstrual cycle and continuing until the 25th day. Withdrawal bleeding occurs 2‑4 days after the last dose. Treatment is repeated cyclically for at least three cycles.
• Endometriosis: 10 mg two or three times daily, given continuously or cyclically (e.g., from day 5 to day 25 of the cycle), depending on the severity of symptoms and physician’s preference.
• Threatened miscarriage: An initial dose of 40 mg (four 10 mg tablets) followed by 10 mg every 8 hours until symptoms resolve. The dose should be tapered gradually once stability is achieved.
• Habitual miscarriage: 10 mg twice daily, initiated as soon as pregnancy is confirmed and continued until the 20th week of gestation. The dose may be tapered gradually thereafter under medical supervision.
• Secondary amenorrhoea: An estrogen is administered for 28 days, with dydrogesterone 10 mg twice daily added during the last 12‑14 days of the estrogen cycle. Withdrawal bleeding should occur 2‑4 days after the last dydrogesterone dose.
• Dysfunctional uterine bleeding: 10 mg twice daily from day 11 to day 25 of the cycle (with an estrogen given continuously or in the follicular phase).
• Endometrial protection in HRT (postmenopausal women with a uterus): 10 mg once or twice daily for the last 12‑14 days of each estrogen cycle. If breakthrough bleeding occurs, the dose may be increased to 20 mg daily.
• Administration: Swallow the tablet whole with a glass of water. It may be taken with or without food. For cyclic regimens, take the tablet at approximately the same time each day during the treatment period. The scored tablet can be divided to achieve a 5 mg dose if prescribed (though the standard dose is 10 mg).
• Missed dose: If a dose is missed, take it as soon as remembered on the same day. If it is close to the time of the next dose, skip the missed dose and resume the regular schedule. Do not double the dose. If a cyclic regimen is interrupted, the pattern of withdrawal bleeding may be altered.

Side Effects and Contraindications

• Common side effects (1‑10%): Headache, dizziness, nausea, abdominal pain, breast tenderness, spotting or breakthrough bleeding, and mood changes (depression, irritability). These effects are usually mild and transient, and they tend to improve with continued use or dose adjustment.
• Uncommon side effects (0.1‑1%): Migraine, weight gain, oedema, and skin reactions (rash, pruritus).
• Rare but serious side effects: Cholestatic jaundice, hepatic dysfunction, severe depression, and allergic reactions including anaphylaxis. In the context of HRT, the combination of dydrogesterone and estrogen is associated with an increased risk of venous thromboembolism, stroke, and breast cancer, although the absolute risk is low.
• Safety in pregnancy: Dydrogesterone has been used extensively in early pregnancy for luteal phase support and threatened miscarriage without evidence of an increased risk of congenital malformations. It is considered safe for use during the first trimester under medical supervision. Use later in pregnancy is less well documented.
• Contraindications: Known hypersensitivity to dydrogesterone or any excipient; severe hepatic impairment or active liver disease; undiagnosed abnormal vaginal bleeding; known or suspected progestin‑dependent neoplasia; active venous thromboembolism; and pregnancy (for non‑obstetric indications unless specifically indicated).

Drug Interactions

• Enzyme‑inducing drugs (reduce progestin efficacy): Rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, topiramate, griseofulvin, and St. John’s wort can increase the hepatic metabolism of dydrogesterone and may reduce its clinical effect, leading to breakthrough bleeding or reduced endometrial protection. Alternative or additional protective measures may be required.
• CYP3A4 inhibitors (increase dydrogesterone exposure): Ketoconazole, itraconazole, clarithromycin, and ritonavir may increase dydrogesterone levels, potentially increasing the risk of side effects. Dose reduction may be considered.
• Cyclosporine: Progestogens may inhibit the metabolism of cyclosporine, increasing its serum levels and toxicity. Cyclosporine levels should be monitored.
• Alcohol and food: No significant food or alcohol interactions have been established, but heavy alcohol consumption should be avoided because of its potential to impair liver function and exacerbate mood disturbances.

Practical Advice

• Administration: Take the tablet at the same time each day during your prescribed treatment days. If you are using a cyclic regimen, mark your calendar to remember start and stop dates. Swallow the tablet whole; the scored tablet may be split if a lower dose is required.
• Monitoring: Before starting long‑term therapy (e.g., for endometriosis or HRT), a complete medical history and physical examination should be performed, including blood pressure measurement and breast examination. Any unexplained vaginal bleeding must be investigated. During HRT, mammography should be carried out according to age‑appropriate screening protocols. Liver function tests should be monitored periodically in women with pre‑existing liver disease or those taking other hepatotoxic medications.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep the container tightly closed. Keep out of the reach and sight of children.
• Lifestyle: Maintain a healthy diet and regular exercise to help manage weight gain and fluid retention. Report any sudden severe headache, vision changes, leg pain or swelling, or chest pain immediately. Do not smoke, particularly if over 35, as it greatly increases cardiovascular risk when using combined hormone therapy. If you are scheduled for surgery or prolonged immobilisation, inform your doctor; you may need to stop dydrogesterone temporarily.
• Missed dose: If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
• When to seek medical review: Contact your doctor immediately if you experience: signs of a blood clot (leg pain/swelling, sudden chest pain, coughing up blood, shortness of breath); signs of a stroke (sudden severe headache, confusion, weakness on one side of the body, vision changes); signs of liver problems (jaundice, dark urine, right upper abdominal pain); a new breast lump; severe depression; or, during pregnancy, severe abdominal pain or decreased fetal movement.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Micronised progesterone (Prometrium®): A bio‑identical progesterone that is chemically identical to natural progesterone. It is used for luteal phase support, threatened miscarriage, and endometrial protection. It has a favourable metabolic profile but may cause more drowsiness and dizziness due to its sedative metabolites. Dydrogesterone offers the advantage of a non‑sedative profile and equivalent endometrial protection without the androgenic side effects of some synthetic progestins.
• Medroxyprogesterone acetate (Provera®): A synthetic progestin used for endometrial protection and menstrual regulation. It is more likely to cause androgenic side effects and may negatively affect lipid profiles compared with dydrogesterone.
• Norethindrone acetate (Aygestin®): Another synthetic progestin with similar indications. Norethindrone has some androgenic activity, which may be beneficial in women with heavy bleeding but may cause acne or hirsutism in others.
• Levonorgestrel‑releasing intrauterine system (Mirena®, Kyleena®): Provides long‑acting local progestin delivery directly to the endometrium, used for heavy menstrual bleeding and endometrial protection during HRT. It avoids systemic progestin side effects but requires insertion by a healthcare professional.
• For infertility and recurrent miscarriage: Vaginal progesterone suppositories or gel (e.g., Endometrin®, Crinone®) deliver progesterone directly to the uterus with lower systemic side effects. They are often used in assisted reproductive technology (ART) protocols.
• Non‑hormonal alternatives: For heavy menstrual bleeding, tranexamic acid (Cyklokapron®) and non‑steroidal anti‑inflammatory drugs (e.g., ibuprofen) can be effective. For endometriosis pain, analgesics and non‑pharmacological approaches such as pelvic physiotherapy and acupuncture may be helpful adjuncts.

Clinical Efficacy

Dydrogesterone has been extensively studied for a variety of gynaecological and obstetric indications. In luteal phase insufficiency, it has been shown to improve endometrial histology, correct menstrual irregularity, and increase pregnancy rates. A meta‑analysis of randomised trials in threatened miscarriage found that dydrogesterone significantly reduces the risk of pregnancy loss compared with placebo or no treatment, with a relative risk of miscarriage of approximately 0.47. For habitual miscarriage, dydrogesterone started in early pregnancy is associated with a live birth rate of approximately 70‑80% in women with documented luteal phase deficiency. In endometriosis, dydrogesterone effectively reduces pelvic pain, dysmenorrhoea, and dyspareunia, and is comparable to other progestins in symptom relief. For endometrial protection in HRT, dydrogesterone at a dose of 10 mg once or twice daily for 12‑14 days per cycle provides effective secretory transformation and reduces the risk of endometrial hyperplasia to background levels. Observational data from large European cohorts have suggested that dydrogesterone may be associated with a lower risk of breast cancer and venous thromboembolism compared with other synthetic progestins. Dydrogesterone is included in the World Health Organization Model List of Essential Medicines for its role in reproductive health, and it is recommended by the International Federation of Gynecology and Obstetrics (FIGO) and other professional societies for the treatment of threatened miscarriage and luteal phase support.

Important:

Dydrogesterone is a prescription medication that should be used only under the supervision of a qualified healthcare professional. When used as part of combined hormone replacement therapy in postmenopausal women, it is associated with increased risks of breast cancer, stroke, and venous thromboembolism (blood clots). The lowest effective dose should be used for the shortest possible duration. In women of childbearing potential not seeking to conceive, effective contraception should be used, as dydrogesterone does not reliably prevent ovulation. For women using dydrogesterone for luteal phase support or threatened miscarriage, it should be initiated only after a confirmed intrauterine pregnancy and under appropriate monitoring. Seek immediate medical attention if you develop symptoms of a blood clot, stroke, or liver problems. This product is not currently marketed in Canada and is imported for personal use under a valid prescription. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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