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Source: Leonetti HB, et al. Transdermal progesterone cream for vasomotor symptoms and postmenopausal bone loss. Obstet Gynecol 1999;94:225-228.
Design and Setting: Randomized, double-blind, placebo-controlled trial in Bethlehem, PA.
Subjects: 102 healthy postmenopausal women who were within five years of menopause and had not taken hormonal therapy for at least a year. Twelve women dropped out (two for rashes—one in each group; two for unrelated hospitalizations; and eight failed to keep appointments or missed more than 15% of medication doses). Final analysis was done on 90 women (43 in the treatment group and 47 in the placebo group).
Treatment: Transdermal progesterone cream.
Dose/Route/Duration: One quarter teaspoon of cream (containing 20 mg progesterone or placebo) was applied to the skin daily; all women received both multivitamins and 1,200 mg calcium daily. The study lasted one year and patients were seen every four months.
Outcome Measures: Bone mineral density (measured in the lumbar spine and hip by dual energy x-ray absorptiometry), symptomology, and lipid profiles.
Results: There were no significant differences between the treatment and control groups in terms of change from initial bone mineral density (of the lumbar spine, femoral neck, or total hip) nor in the number of subjects in each group who showed an increase of bone mineral density of over 1.2%. Eight women in the treatment group experienced vaginal spotting. Biopsies found proliferative endometrium in one woman, the other seven had tissue insufficient for diagnosis. Controls and women in the treatment group had vasomotor symptoms. Of those who reported vasomotor symptoms initially, 5/26 women in the control group reported improved vasomotor symptoms compared to 25/30 women in the treatment group. No significant changes were seen in lipids or mood ratings between groups or from baseline.
Funding: "In part" by Astraea, Inc. (Portland, OR); donations from June Pearson, MD.
Comments: This study should lay to rest the notion that progesterone cream increases bone density. (See Alternative Therapies in Women’s Health, April 1999, pp. 33-36.) It has been known for some time that progestins can decrease hot flashes, but it is news that transdermal creams can have this effect (a previous study1 found that serum levels of progesterone from transdermal creams were only a third of those obtained from oral micronized progesterone).
1. Cooper A, et al. Systemic absorption of progesterone from Progest cream in postmeno-pausal women. Lancet 1998;351:1255-1256.