When is Duphaston (dydrogesterone) indicated?

When is Duphaston (Dydrogesterone) Given?

Duphaston is primarily indicated for endometrial protection in postmenopausal hormone replacement therapy, and for treatment of progesterone-deficiency conditions including threatened/recurrent miscarriage, luteal phase support in assisted reproduction, irregular menstrual cycles, dysmenorrhea, and premenstrual syndrome.

Primary Indication: Hormone Replacement Therapy

Postmenopausal Women with Intact Uterus

• Dydrogesterone 10 mg daily for 12-14 days per month is recommended as a sequential regimen option when combined with continuous estrogen therapy 1
• Dydrogesterone 5 mg daily continuously is recommended for continuous combined regimens to avoid withdrawal bleeding 1
• The American College of Obstetricians and Gynecologists endorses dydrogesterone as an alternative progestogen for endometrial protection, though micronized progesterone remains first-line due to superior cardiovascular safety profile 1
• Dydrogesterone should be paired with transdermal 17β-estradiol 50-100 μg daily rather than oral formulations to minimize cardiovascular and thrombotic risk 1

Important Caveat for HRT Use

• While dydrogesterone is FDA-approved and guideline-endorsed for HRT, micronized progesterone (200 mg daily for 12-14 days) is explicitly preferred as first-line due to lower cardiovascular and thrombotic risk 1
• Dydrogesterone is considered a second-choice progestin when micronized progesterone is not tolerated or available 1

Pregnancy-Related Indications

Threatened and Recurrent Miscarriage

• Dydrogesterone significantly improves pregnancy outcomes in women with threatened miscarriage or history of recurrent miscarriage 2
• Clinical trials, systematic reviews, and meta-analyses demonstrate efficacy for this indication 2
• Treatment is typically continued until week 10 of pregnancy if pregnancy is achieved 3

Luteal Phase Support in Assisted Reproductive Technology

• Oral dydrogesterone 10 mg twice daily (20 mg total) is as effective as vaginal micronized progesterone for luteal phase support 3
• Administered from day of oocyte retrieval (day 0) until pregnancy test, or until week 10 if pregnancy occurs 3
• Ongoing pregnancy rates are comparable to vaginal progesterone (30.3% vs 28.1%) 3
• Patients report significantly higher satisfaction and tolerability compared to vaginal progesterone, with fewer local adverse effects, less vaginal bleeding, and less interference with coitus 3

Infertility Due to Luteal Phase Insufficiency

• Dydrogesterone is indicated for treatment of infertility associated with luteal phase insufficiency 2
• Does not inhibit ovulation at standard doses, allowing natural ovulatory cycles to continue 4

Menstrual Disorder Indications

Dysmenorrhea

• Dydrogesterone 20 mg daily (10 mg twice daily) during the second half of the menstrual cycle effectively relieves dysmenorrhea 5
• Best treatment results are obtained for dysmenorrhea among premenstrual complaints 5

Irregular Menstrual Cycles and Bleeding Irregularities

• Dydrogesterone is indicated for treatment of irregular menstrual cycles 4
• Excellent results for bleeding irregularities when administered during the luteal phase 5

Premenstrual Syndrome

• Dydrogesterone 20 mg daily (10 mg twice daily) during the second half of the menstrual cycle relieves premenstrual symptoms 5
• Best results for depression, edema, dysmenorrhea, and bleeding irregularities 5
• Mastodynia may be less responsive to dydrogesterone therapy 5

Special Populations

Premature Ovarian Insufficiency

• For adolescents with premature ovarian insufficiency, dydrogesterone 5-10 mg daily for 12-14 days per month is recommended after at least 2 years of estrogen-only therapy 1
• Treatment should continue until the average age of natural menopause (45-55 years) 1

Key Clinical Advantages of Dydrogesterone

Pharmacological Profile

• High oral bioavailability compared to natural progesterone 6
• Greater selectivity for progesterone receptor 2
• Does not inhibit ovulation at standard doses 4
• Devoid of estrogenic or androgenic properties 4
• Does not induce metabolic side effects 4
• Menstrual cycles remain ovulatory under therapy 5

Safety and Tolerability

• Well-established favorable benefit-risk profile in pregnant women 2
• Blood pressure and body weight not significantly altered 5
• Generally well tolerated with minimal systemic side effects 4

Critical Monitoring and Contraindications

Before Initiation

• Blood pressure measurement required before starting HRT 7
• Rule out pregnancy if any uncertainty exists 7
• No routine pelvic examination required unless clinically indicated 7

Contraindications (FDA Label)

• Active liver disease 8
• Current or history of breast cancer or hormone-sensitive malignancies 8
• Undiagnosed abnormal vaginal bleeding 8
• Known or suspected pregnancy (for HRT indication) 8

Monitoring During Treatment

• Annual clinical review focusing on compliance, bleeding patterns, and symptom control 1
• No routine laboratory monitoring required unless specific symptoms arise 1
• If withdrawal bleeding does not occur within 3 weeks in sequential regimens, pregnancy testing is advised 7