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Use of compounded hormone therapy in the United States

report of The North American Menopause Society Survey

Gass, Margery L.S. MD, NCMP1; Stuenkel, Cynthia A. MD, NCMP2; Utian, Wulf H. MD, PhD, DSc(Med)1; LaCroix, Andrea NCMP, PhD3; Liu, James H. MD4; Shifren, Jan L. MD, NCMP5 This survey was developed by The North American Menopause Society (NAMS) Advisory Panel consisting of representatives of the NAMS Board of Trustees and other experts in women's health:

doi: 10.1097/GME.0000000000000553
NAMS Survey

Objective: A national survey was conducted to determine the extent of use of compounded hormone therapy (C-HT) and to characterize the differences between C-HT users and users of hormone therapy approved by the US Food and Drug Administration (FDA-HT users).

Methods: This Internet survey enrolled 3,725 women aged 40 to 84 years who were postmenopausal or experiencing the menopause transition. The sample was weighted slightly by age, region, education, and race to reflect population attributes based on US Census data.

Results: Overall, 9% of women were current users of HT, and 28% of all respondents were ever-users of HT. C-HT users represented 31% of ever-users of HT, 35% of current users of HT, and 41% of ever-users aged 40 to 49 years. Approximately 13% of ever-users indicated current or past use of testosterone. The most cited reason for using HT was vasomotor symptoms (∼70%). Nonapproved indications for using HT were selected more often by C-HT users. There were four reports of endometrial cancer among the 326 C-HT users compared with none reported among the 738 FDA-HT users. Significance was not determined because of small numbers.

Conclusions: This survey indicates substantial use of C-HT across the country and the possibility of higher rates of endometrial side effects with such products. There is a need for standardized data collection on the extent of use of compounded hormones and their potential risks.

1North American Menopause Society, Mayfield Heights, OH

2Endocrinology and Metabolism Service, University of California, San Diego, School of Medicine

3Division of Epidemiology, University of California, San Diego, School of Medicine

4Department of Obstetrics and Gynecology, University Hospitals Case Medical Center, Cleveland, OH

5Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA.

Address correspondence to: The North American Menopause Society, 5900 Landerbrook Dr., Suite 390, Mayfield Heights, OH 44124. E-mail:

Received 27 August, 2015

Revised 27 August, 2015

Accepted 27 August, 2015

Financial disclosure/conflicts of interest: M.L.S.G. and C.S. report no conflicts. W.H.U. has participated as a consultant/advisory board member for Pharmavite and PulseNMore. A.L. is on the advisory board for Amgen and Sermonix and attended an advisory meeting for Pfizer. J.H.L. has participated as a consultant/advisory board member or received honoraria from Ferring, Nora, Noven, Decile Ten, Huntworth Health North America and has performed patent litigation consulting for Actavis. J.L.S. reports serving as a consultant/advisory board member for New England Research Institutes and has received royalties or patents for UpToDate.

This survey was made possible through an unrestricted grant from TherapeuticsMD.

© 2015 by The North American Menopause Society.