Shifren · Menopause (New York, N.Y.) 2007 · randomized open-label crossover trial · n=27

A randomized, open-label, crossover study comparing the effects of oral versus transdermal estrogen therapy on serum androgens, thyroid hormones, and adrenal hormones in naturally menopausal women.

Cited 87 times in the scientific literature.

Level 2 - randomized trial

Individual randomized crossover trial

PubMed 17507833 · doi:10.1097/gme.0b013e31803867a · record verified 2026-08-29

What was done

A randomized, open-label, crossover trial evaluated 27 naturally menopausal women (25 completed both arms). Following a 6-week withdrawal from prior hormone therapy, participants received 12 weeks of oral conjugated equine estrogens (CEE, 0.625 mg/day) and 12 weeks of transdermal estradiol (TD E2, 0.05 mg/day) in randomized order, with oral micronized progesterone (100 mg/day) co-administered continuously during both regimens. Total and free concentrations of testosterone, thyroxine (T4), and cortisol, along with their binding globulins (SHBG, TBG, CBG), were measured.

What was found

Oral CEE markedly increased binding globulins and altered free hormone concentrations, whereas transdermal E2 had minimal effects: - SHBG: +132.1% (SD 74.5%) with oral CEE vs +12.0% (SD 25.1%) with TD E2. - Total testosterone: +16.4% (SD 43.8%) with oral CEE vs +1.2% (SD 43.7%) with TD E2. - Free testosterone: -32.7% (SD 25.9%) with oral CEE vs +1.0% (SD 45.0%) with TD E2. - TBG: +39.9% (SD 20.1%) with oral CEE vs +0.4% (SD 11.1%) with TD E2. - Total T4: +28.4% (SD 29.2%) with oral CEE vs -0.7% (SD 16.5%) with TD E2. - Free T4: -10.4% (SD 22.3%) with oral CEE vs +0.2% (SD 26.6%) with TD E2. - CBG: +18.0% (SD 19.5%) with oral CEE vs -2.2% (SD 11.3%) with TD E2. - Total cortisol: +29.2% (SD 46.3%) with oral CEE vs -6.7% (SD 30.8%) with TD E2. - Free cortisol: +50.4% (SD 126.5%) with oral CEE vs +1.8% (SD 77.1%) with TD E2. Concentrations of all binding globulins and total hormones differed significantly between routes (P <= 0.003), whereas free T4 and free cortisol did not differ significantly.

Why it matters

Unlike oral estrogens, which induce hepatic protein synthesis and reduce bioavailable free testosterone, transdermal estradiol bypasses first-pass hepatic metabolism and avoids major perturbations in binding globulins and circulating hormone levels.

Limits

The sample size was small (27 enrolled, 25 completed), and the trial was open-label. Only specific fixed doses of oral CEE and transdermal estradiol were tested, both in combination with oral micronized progesterone, and the abstract did not report clinical symptoms or long-term outcomes.

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