What are the indications and dosing guidelines for Dydrogesterone (progesterone derivative)?

Dydrogesterone: Indications and Dosing Guidelines

Dydrogesterone is indicated for treatment of moderate to severe vasomotor symptoms due to menopause, vulvar and vaginal atrophy, hypoestrogenism due to hypogonadism or primary ovarian failure, and prevention of postmenopausal osteoporosis, with dosing typically 5-10 mg daily for 12-14 days per month in cyclic regimens. 1

Main Indications

Dydrogesterone is a synthetic progestogen with a molecular structure similar to natural progesterone but with greater bioavailability and higher selectivity for progesterone receptors. It has several clinical applications:

1. Menopausal Hormone Therapy

   • For women with an intact uterus receiving estrogen therapy
   • Dosage: 5-10 mg daily for 12-14 days per 28-day cycle in sequential regimens 2, 3

2. Premature Ovarian Insufficiency (POI)

   • For adolescents with POI after estrogen therapy
   • Dosage: 5-10 mg daily during 12-14 days of the month 2
   • Begin cyclical progestogens after at least 2 years of estrogen or when breakthrough bleeding occurs

3. Other Gynecological Indications (based on clinical evidence)

   • Dysmenorrhea: 5 mg twice daily from day 5-25 of menstrual cycle 4
   • Irregular menstrual cycles: Used for menstrual cycle regularization 5
   • Threatened or recurrent miscarriage 6, 7
   • Luteal phase support in assisted reproduction 6

Dosing Guidelines

For Menopausal Hormone Therapy:

• Standard dose: 5-10 mg daily for 12-14 days per month in cyclic regimens 2, 3
• Preferred over medroxyprogesterone acetate due to less negative effects on lipid metabolism and less androgenic effects 2

For Adolescents with POI:

• Begin after at least 2 years of estrogen therapy or when breakthrough bleeding occurs
• Dosage: 5-10 mg daily during 12-14 days of the month 2

For Extended-Release Formulations:

• Dydrogesterone 20 mg SR and 30 mg SR are typically prescribed once daily (OD) 8
• These formulations reduce pill burden compared to multiple daily dosing regimens

Advantages and Considerations

• Dydrogesterone does not inhibit ovulation at standard doses and is devoid of estrogenic or androgenic properties 6
• It has minimal metabolic side effects, making it suitable throughout a woman's lifetime 6
• For women with an intact uterus receiving estrogen therapy, progestin (such as dydrogesterone) must be administered to reduce endometrial cancer risk 3
• Preferred over other progestogens due to less negative effects on lipid metabolism 2

Contraindications and Precautions

• History of hormonally mediated cancers
• Undiagnosed vaginal bleeding
• Active thromboembolic disorders
• Current or history of arterial thrombotic disease 3

Monitoring and Follow-up

• Clinical review every 3-6 months initially, then annually
• Use the lowest effective dose for the shortest duration consistent with treatment goals
• Regular reassessment of risks and benefits 3

Common Adverse Effects

• Metrorrhagia (irregular uterine bleeding) is the most commonly reported adverse event 4
• Overall incidence of adverse drug reactions is approximately 31.8% 4

Dydrogesterone has a well-established safety profile and is effective across various indications related to progesterone deficiency, with dosing regimens that should be tailored based on the specific indication and patient characteristics.