Transdermal progesterone cream as an alternative progestin in hormone therapy.

OBJECTIVE To evaluate the endometrial effects and determine patients' acceptance of transdermal progresterone cream compared to standard hormone therapy. METHODS Healthy menopausal women were recruited and received a pretreatment endometrial biopsy (EMB). They were randomized to 0.625 mg conjugated equine estrogen (CEE) daily and 2.5 mg medroxyprogesterone acetate (MPA) (Prempro, Wyeth USA) or daily 0.625 mg CEE and twice daily 20 mg transdermal PC (Pro-gest, Transitions for Health USA). At the end of 6 months, a repeat EMB was obtained, and the women were crossed over to other treatment. A final EMB was performed after the final 6 months. RESULTS Twenty-six women completed both arms of the study. Seventy-seven percent of women preferred the CEE/PC to the CEE/MPA (P<.001). Of the 52 post-treatment endometrial biopsies: 40 revealed atrophic endometrium and 12 proliferative endometrium (7 in the oral progestin group and 5 in the PC group). There was no evidence of endometrial hyperplasia in any of the specimens. The incidence of vaginal spotting was similar in both groups. CONCLUSION Patients preferred transdermal PC over oral MPA. This preliminary data indicate that CEE/PC has a similar effect on the endometrium as standard oral HT over a 6-month period.

[1]  J. Eden,et al.  Transdermal progesterone and its effect on vasomotor symptoms, blood lipid levels, bone metabolic markers, moods, and quality of life for postmenopausal women , 2003, Menopause.

[2]  Heidi D Nelson,et al.  Postmenopausal hormone replacement therapy: scientific review. , 2002, JAMA.

[3]  P. Elder,et al.  Caution on the use of saliva measurements to monitor absorption of progesterone from transdermal creams in postmenopausal women. , 2002, Maturitas.

[4]  S. Evans,et al.  Salivary, but not serum or urinary levels of progesterone are elevated after topical application of progesterone cream to pre‐and postmenopausal women , 2000, Clinical endocrinology.

[5]  N. Watson,et al.  Comparison of the pharmacokinetics of crinone 8% administered vaginally versus Prometrium administered orally in postmenopausal women(3). , 2000, Fertility and sterility.

[6]  J. Eden,et al.  Effect of sequential transdermal progesterone cream on endometrium, bleeding pattern, and plasma progesterone and salivary progesterone levels in postmenopausal women , 2000, Climacteric : the journal of the International Menopause Society.

[7]  S. Longo,et al.  Transdermal progesterone cream for vasomotor symptoms and postmenopausal bone loss. , 1999, Obstetrics and gynecology.

[8]  K. Hermsmeyer,et al.  Percutaneous absorption of progesterone in postmenopausal women treated with transdermal estrogen. , 1999, American journal of obstetrics and gynecology.

[9]  D. Ross,et al.  Systemic absorption of progesterone from Progest cream in postmenopausal women , 1998, The Lancet.

[10]  J. Studd,et al.  Progestogen intolerance and compliance with hormone replacement therapy in menopausal women. , 1997, Human reproduction update.

[11]  J. Simon.  Micronized progesterone: vaginal and oral uses. , 1995, Clinical obstetrics and gynecology.

[12]  C. Nappi,et al.  Endometrial hyperplasia: efficacy of a new treatment with a vaginal cream containing natural micronized progesterone. , 1994, Maturitas.

[13]  J. Woodruff,et al.  Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone. The Menopause Study Group. , 1994, American journal of obstetrics and gynecology.

[14]  A. Lethaby,et al.  Hormone replacement therapy in postmenopausal women: endometrial hyperplasia and irregular bleeding. , 2004, The Cochrane database of systematic reviews.

[15]  H. B. Leonetti,et al.  Topical progesterone cream has an antiproliferative effect on estrogen-stimulated endometrium. , 2003, Fertility and sterility.

[16]  D. Miron,et al.  Pharmacokinetics of progesterone in postmenopausal women: 2. Pharmacokinetics following percutaneous administration. , 1998, European journal of drug metabolism and pharmacokinetics.