Is combination Hormone Replacement Therapy (HRT) available in India for estrogen plus progesterone therapy?

Combination HRT Availability in India

Yes, combination hormone replacement therapy (HRT) containing both estrogen and progesterone is available in India, with multiple formulations including oral tablets, transdermal patches, and various progestogen options.

Available Combination Formulations

Oral Combined HRT Options

• Sequential regimens are widely available, typically containing estradiol valerate (2 mg) combined with various progestogens for 10-14 days per cycle 1
• Continuous combined preparations containing estradiol with progestogens like dydrogesterone (5 mg daily) or medroxyprogesterone acetate (2.5 mg daily) are marketed in India 2
• Specific branded products include formulations with cyproterone acetate (1 mg) combined with estradiol valerate (2 mg) for sequential use 3

Transdermal Options

• Estradiol patches are available in India, though these typically require separate oral progestogen supplementation 1
• Combined estrogen-progestogen patches exist in some markets but availability in India may be limited 2

Recommended Progestogen Components

First-Line Progestogen Choices

• Micronized progesterone (100-200 mg daily for 12-14 days/month) is the preferred progestogen due to superior cardiovascular and thrombotic safety profile compared to synthetic progestins 1, 4
• Dydrogesterone (5-10 mg daily for 12-14 days in sequential regimens, or 5 mg daily for continuous) is listed among recommended progestogens by ESHRE guidelines 1, 2

Alternative Progestogen Options

• Medroxyprogesterone acetate (10 mg daily for 12-14 days sequential, or 2.5 mg daily continuous) demonstrates full effectiveness in endometrial protection but may have less favorable cardiovascular effects 1, 2
• Norethisterone acetate is available but shows worse profile regarding blood pressure and renal function compared to natural progesterone 1

Optimal HRT Regimen Selection

For Women with Intact Uterus

• Transdermal 17β-estradiol (50-100 mcg/day) combined with oral micronized progesterone (200 mg for 12-14 days/month) represents the optimal combination for cardiovascular safety and endometrial protection 1, 4
• Sequential regimens allow withdrawal bleeding and earlier pregnancy recognition in women with premature ovarian insufficiency who may spontaneously ovulate 1
• Continuous combined regimens prevent withdrawal bleeding and are appropriate for women beyond early menopause 2, 5

Route of Administration Considerations

• Transdermal estradiol is preferred over oral to minimize risks of venous thromboembolism, stroke, and gallbladder disease 1, 4
• Oral 17β-estradiol (2-4 mg daily) is preferred over ethinylestradiol or conjugated equine estrogens when oral route is chosen 1
• Vaginal micronized progesterone (200 mg daily) provides adequate endometrial protection as an alternative to oral administration 2, 6

Critical Prescribing Considerations

Endometrial Protection Requirements

• Any woman with an intact uterus receiving estrogen must receive concurrent progestogen to prevent endometrial hyperplasia and cancer 7, 8
• Progestogen must be administered for at least 12-14 days per month in sequential regimens to provide adequate endometrial protection 6
• Continuous combined regimens provide superior long-term endometrial protection compared to sequential regimens 4, 9

Monitoring and Duration

• Annual clinical review is required, with particular attention to compliance 1
• No routine monitoring tests are needed unless prompted by specific symptoms 1
• Treatment should use the lowest effective dose for the shortest duration consistent with treatment goals 7, 5

Common Pitfalls to Avoid

• Inadequate progestogen duration (<12 days/month) fails to provide sufficient endometrial protection 6
• Using synthetic progestins with androgenic properties (like norethisterone) may attenuate beneficial cardiovascular effects of estrogen 1, 9
• Prescribing oral estrogen in women with hypertension, diabetes, or cardiovascular risk factors when transdermal would be safer 1, 4
• Many micronized progesterone capsules contain peanut oil, contraindicated in severe peanut allergy 6