Menopause: The Journal of "re North American Menopause Society
`Vol. 22, No. 9. pp 926-936
`D01: 10.1097/GME.000(X11XXX11XX)0420
`0 2015 by The North American Menopause Society
`
`Compounded bioidentical hormone therapy: identifying use trends and
`knowledge gaps among US women
`
`JoAnn V. Pinkerton, MD,’ and Nanette Santoro, MD)
`
`Abstract
`
`Objective: Two surveys (Harris and Rose surveys) were conducted to quantify the use of compounded hormone
`therapy (CHT; or bioidentital hormone therapy) among perimenopausal and postmenopausal women in the United
`States, to assess women’s knowledge of CHT versus Food and Dmg Administration (FDA)—approved hormone
`therapy, and to gather information on menopausal experience.
`Methods: The Harris survey was administered to 801 women aged 45 to 60 years who had experienced at least
`one menopausal symptom. The Rose survey was adrninisteredto 2,044 women aged 40 years or older who were ever
`users ofhormone therapy. Women were queried about menopausal symptoms, hormone therapy use, and knowledge
`of CHT . Findings fiom the Rose survey were extrapolated using US Census Bureau data and prescription claims for
`FDA-approved hormone therapy to estimate the prevalence of CHT use.
`Results: According to extrapolations using Rose data, up to 2.5 million US women aged 40 years or older may
`use CHT annually, accounting for 28% to 68% of hormone therapy prescriptions. Harris data showed that 86% of
`women surveyed were unaware that CHT products are not FDA-approved. The Rose survey asked a subset of 1,771
`women whether their hormone therapy had been personalized based on hormone levels; 21% (378) answered “yes’ ’
`whereas 27% (476) did not know. In both surveys, most hormone therapy users stated that their physician had
`recommended the treatment.
`
`Conclrm'ons: We estimate that 1 million to 2.5 million US women aged 40 years or older use CHT. The data
`suggest that many women are unaware that compounded hormones have not been evaluated or approved by the
`FDA. Providers have an educational opportunity to ensure that women considering hormone therapy understand the
`risks and benefits of inadequately regulated CHT.
`Key Words: Compounded hormone therapy—Menopause — Bioidentical — Vasomotor symptoms — Hot flashes.
`
`H ormone therapy(HT) effectivelytreats moderate to
`
`severe vasomotor symptoms (VMS) and sympto-
`matic vaginal atrophy and prevents postmenopausal
`osteoporosis in women transitioning through menopause.l
`Although the use of commercially manufactured HT to treat
`
`revised and accepted November 25, 2014.
`Received October 3, 2014;
`From the ‘University of Virginia Health System, Charlottesville, VA;
`and 2University of Colorado School of Medicine, Aurora, CO.
`Funding/support: TheiapeuticsMD supported the conduct and analysis of
`the surveys and funded medical writing support (provided by Christin
`Melton, ELS, CMPP, of Precise Publications LLC).
`Financial disclosure/conflicts of interest: J.V.P. has received grants and
`research support (paid to the University of Virginia) ti'om Therapeu
`tiesMD Inc, Bionova Inc, and EndoCeuties Inc, and has served as a
`consultant (fires paid to the University ofVirginia) for Pfizer Inc, Noven
`Pharmaceuticals Inc, TherapeuticsMD Inc, and Shionogi Inc. N.S. has
`received investigator initiated grant support from Bayer Inc maid to the
`University of Colorado School of Medicine) and has stock options in
`MenoGenix.
`
`Address correspondence to: JoAnn V. Pinkerton, MD, University of
`Virginia, Box 801104, Charlottesville, VA 22908. E mail: JVP9U@
`hscmail.mcc.virginia.edu
`This is an open accem article distributed under the terms of the Creative
`Commons Attribution NonCommercial NoDerivatives 3.0 License,
`where it is permissible to download and share the work provided it is
`properly cited The work cannot be changed in any way or used
`commercially.
`
`926 Menopause, Vol. 22, No. 9, 2015
`
`menopausal symptoms has declined during the past 12 years
`in response to the now well-known safety findings of the
`Women’s Health Initiative trials (primarily for women aged
`60 y or older),2'8 use ofcustom compounded hormone therapy
`(CHT) seems to have increased.942 This seemingly para-
`doxical increase in CHT use suggests that postmenopausal
`women do not apply their concerns about the class effects of
`estrogens and progestogens identified in the Women’s Health
`Initiative to CHT products.
`Another driving force behind the use ofCHT seems to be the
`absence of regulation governing product advertising, which
`allows purveyors ofCHT to make unsubstantiated claims about
`its safety and efficacy.'2'l3 In addition, high-profile celebrities
`such as Oprah Winfi'ey and Sumne Somers have promoted
`CHT to postmenopausal women.”'15 Physiciam and pharma-
`cists who stand to benefit economically from the sales of CHT
`may also have encouraged its use.'3'm‘I7
`Although the general consensus is that use of CHT has
`grown,” "'8 prescriptions for CHT are not systematically
`tracked in the United States, and no one knows exactly
`how many women are managing their menopausal symptoms
`with compounded hormones. In a survey of 184 women
`visiting a physician at the Mayo Clinic Women’s Health
`Clinic (Rochester, MN) about 8 years ago, Iftikhar et all9
`
`Biogen Exhibit 2180
`
`Page 1 of 11
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`Copyright
`
`Mylan v. Biogen
`IPR 2018—01403
`2015 The North American Menopause SOCIety. Unauthorized reproduction of this article is prohibited.
`
`

`

`TRENDS IN USE OF COMPOUNDED HORMONE THERAPY
`
`found that 14% of respondents were current CHT users; this
`was twice the rate of prior CHT users. However, because of
`the survey’s age and small nonrepresentative convenience
`sample, it cannot be assumed that these findings would apply
`to a broader population of postmenopausal women today.
`Recently, two large Internet surveys of middle-aged or
`older US women were conducted
`one conducted by Harris
`Interactive Inc (Harris) and one conducted by Rose Research
`LLC (Rose)
`to measure the prevalence of HT and CHT use
`in the United States and to evaluate the extent to which
`perimenopausal and postmenopausal women recognize that
`CHT products are not approved by the US Food and Drug
`Administration (FDA). From the Rose survey, we extrapo-
`lated information on trends in HT use to US Census Bureau
`figures and used a report on HT prescriptions generated from
`Symphony Health’s Pharmaceutical Audit Suite (PHAST) 2.0
`database (Symphony Health, Horsham, PA) of US prescrip-
`tion information to estimate the amount of CHT used in the
`United States and the proportion of HT prescriptions that are
`compounded. We also examined survey data on menopausal
`experience, knowledge of and practices regarding HT, and
`treatment outcomes. We anticipated that the data would show
`a high rate of CHT use and limited knowledge regarding the
`regulatory status of CHT in a sample of reasonably repre-
`sentative perimenopausal and postmenopausal women.
`
`METHODS
`
`Survey design
`The market research firms Harris and Rose each adminis-
`tered a population-based, cross-sectional Internet survey on
`menopause and HT to US women. The source populations were
`drawn from Web-based nonprobability consumer panels main-
`tained by Harris and Global Market Insite (GMI). Members
`were recruited to their respective panels primarily through
`Internet recruitment drives (eg, advertisements and newslet-
`ters) and opted to join the panels. Privacy policies were fully
`disclosed to each member at registration, at which time they
`submitted a profile containing their E-mail address, name,
`home address, age, and other demographic information. An
`e-mail was sent to the e-mail address recorded at registration,
`with a link for panel applicants to confirm their desire to join the
`panel and to sign a confidentiality agreement.
`The Harris survey was conducted between June 24 and July
`10, 2013, and the Rose survey was conducted during three
`consecutive weeks in April 2014. The sample population was
`invited via e-mail to take the survey during the defined time
`frame. The e-mail provided an encrypted link to the survey,
`which is housed on a secure database and must be completed
`in a single sitting. Participation was voluntary, no medical
`procedures were conducted, and risk to participants was
`considered minimal. Although a written informed consent
`form was not formally obtained, respondents were advised
`before they began the survey
`that their opinions regarding
`medications or products that they might be taking for health
`were being sought, and they were assured that their answers
`and identifying information would remain confidential.
`
`Responses were captured electronically and stored on a
`secure private server. Survey administrators applied several
`techniques to exclude duplicate or fraudulent responses.
`Respondents’ digital fingerprints were compared with their
`registered profile, and surveys completed in less than two
`fifths of the median time estimated for completion were
`excluded. Only aggregated deidentified data were provided
`for analyses. As a reward for completing the survey, panel
`members received sweepstakes entries and/or points redeem-
`able for approximately US$10 in cash or merchandise.
`Harris and GMI are members of The World Association for
`Opinion and Marketing Research and comply with the Inter-
`national Chamber of Commerce/World Association for
`Opinion and Marketing Research International Code on Market
`and Social Research. Harris also conforms to the American
`Association for Public Opinion Research Code of Professional
`Ethics and Practices, the Health Insurance Portability and
`Accountability Act, and other US privacy regulations and
`guidelines.
`
`Sample and inclusion criteria
`For the Harris poll, women aged 45 to 60 years who were
`currently going through menopause or had experienced men-
`opause were eligible to participate. With the goal of accruing
`800 completed surveys, Harris invited 10,781 women aged 45
`to 60 years from its consumer panel to take a survey on an
`unspecified topic. Invitations were balanced by US Census
`Bureau statistics for age, race, geographic location, household
`income, and education levels; invitees were systematically
`sampled from among panel members matching each target
`demographic. Quotas were established according to the
`desired number of completers per demographic attribute,
`and additional invitations were sent in batches in blinded
`fashion until each quota was met. These steps were taken to
`help mitigate sample biases and to ensure reliable and project-
`able survey results.
`For the Rose survey, women aged 40 years or older who (1)
`confirmed current or former use of an HT product from a list of
`generic and branded drugs approved by the FDA to treat
`menopausal symptoms or (2) identified themselves as ever
`users of any product for ‘‘hormone therapy replacement or
`supplement’’ were eligible to participate. Women who did not
`indicate current or prior use of an HT product on the list or who
`answered ‘‘no’’ when asked whether they had ever used any
`product for ‘‘hormone therapy replacement or supplement’’
`were excluded. In all, 90,120 women aged 40 years or older
`who belonged to the GMI consumer panel were invited, with
`the intent of obtaining 2,000 completed surveys. As with the
`Harris poll, the Rose survey used systematic sampling of panel
`members to ensure that the number of women invited per
`demographic attribute comported with US Census Bureau
`figures. Additional responses were sent in waves until response
`quotas for all demographic categories were satisfied.
`Throughout
`this report, women who responded to the
`invitation are referred to as ‘‘respondents.’’ Those respond-
`ents who were deemed eligible after answering all screening
`
`Menopause, Vol. 22, No. 9, 2015 927
`
`Copyright ß 2015 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.
`
`Page 2 of 11
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`

`PINKERTON AND SANTORO
`55-59, 60-64, 65-69, 70-74, 75-79, and 80 y). Subset
`analyses were conducted for women aged 50 to 64 years,
`which is the age group more likely to experience menopausal
`symptoms. In addition, responses were stratified by region,
`income level, ethnicity, current or former use, and hyster-
`ectomy or menopause status (perimenopausal and postmeno-
`pausal vs premenopausal).
`There is no consensus for calculating response rates or
`estimating sampling error for a sample drawn from a non-
`probability panel.20 As recommended by the American
`Association for Public Opinion Research20 in accordance
`with terms defined in the International Organization for
`Standardization report ISO 26362:2009, we reported the
`participation rate and cooperation rate, calculated as follows:
`Participation rete ¼ Respondents with usable response
`Invitations sent
`
`questions and who completed the remainder of the survey are
`referred to as ‘‘completers.’’
`
`Survey instrument
`Questionnaires were developed by TherapeuticsMD in con-
`junction with survey administrators. Before the Rose survey
`was fielded, it was tested for face validity among a sample of
`100 women and adjusted as needed. Each of the finalized
`surveys took about 15 minutes to complete. Most questions
`were multiple choice and allowed participants to select only
`one answer. Answer choices were rotated randomly for each
`participant to minimize potential bias, and a response was
`required before proceeding to the next question.
`Harris respondents were asked whether they had ever
`experienced menopausal symptoms and whether they were
`currently experiencing them. Both Harris and Rose com-
`pleters were asked about age at menopausal symptom onset,
`whether they had ever experienced specific menopausal
`symptoms, and severity of any symptoms. Completers in both
`surveys were also asked about HT use (type, where obtained,
`duration, and effectiveness) and specifically about CHT use.
`Because CHT is described in different ways, pertinent ques-
`tions attempted to define CHT using terminology associated
`with how this treatment is prescribed. Harris completers were
`given a list of treatments of menopause symptoms and asked
`to indicate any treatment they had tried, including ‘‘bioident-
`ical hormone replacement therapy (HRT) from a specialty
`pharmacy (personalized specifically for you by a special
`compounding pharmacy
`local or mail order/Internet).’’
`Ever users in the Rose survey were asked, ‘‘Was your
`prescription for hormone therapy specifically formulated,
`personalized, or compounded specifically for you based on
`your hormone levels?’’ This question was added to the survey
`after 273 of the eventual completers had already taken the
`survey to permit the collection of more complete information
`on CHT use. Only Harris completers were asked, ‘‘Do you
`believe that bioidentical hormone therapies compounded at a
`specialty pharmacy are FDA-approved?’’
`
`Cooperative rate
`
`Complete interviews
`ðComplete þ partial interviewsÞ þ refusal=breakoff þ other
`
`We also calculated the qualification rate using the following
`formula:
`
`Qualification rate
`
`Eligible respondents
`Respondents with a usable response
`
`To estimate US trends in CHT use and annual spending on
`CHT, we used Rose survey information on rate of current HT
`use, number and cost of HT products used, and duration of
`use; the 2012 census estimates; and a summary report of HT
`prescriptions filled by US women aged 18 years or older. The
`report was generated using PHAST 2.0 (Symphony Health), a
`database of prescription information collected weekly from
`retail, mail order, and specialty pharmacies across the United
`States. (Calculations are detailed in ‘‘Results.’’)
`
`RESULTS
`Response rates and demographic information
`The Harris survey invited 10,781 women aged 45 to 60
`years, via e-mail, to participate in an online survey between
`June 24 and July 10, 2013 (Fig. 1). A total of 1,099 women
`responded (participation rate, 10%). Of these women, 855 had
`experienced or were experiencing menopausal symptoms and
`were thus eligible (qualification rate, 78%). The cooperation
`rate was 94%, with 801 of 855 eligible women completing
`the survey.
`An invitation to take the Rose survey was e-mailed to
`90,210 individuals during a 3-week period in April 2014, and
`17,897 invitees responded (participation rate, 20%). Seventy-
`two respondents were men and were excluded. Screening of
`the remaining 17,825 Rose respondents identified 2,369
`women aged 40 years or older who were currently using or
`had previously used HT and were eligible to complete the
`survey (qualification rate, 13%). The cooperation rate was
`86%, with 2,044 of 2,369 eligible women completing the
`survey. Subset analysis in the Rose survey included 855
`respondents aged 50 to 64 years, of whom 839 completed
`
`Data analyses
`Weighting by US Census Bureau statistics was applied to
`the final pool of Harris respondents to ensure that demo-
`graphic attributes of age, race, and geographic distribution
`were proportional with the general population of US women.
`The Harris survey also weighted results to the US population
`by age, income level, educational status, and race, which did
`not materially affect outcomes. The pool of Rose respondents
`yielded a population of completers well-matched to the gen-
`eral population on target demographic variables and did not
`require weighting. Both surveys were slightly underweighted
`for race (80%-84% of completers were white). In analyzing
`data for eligible completers, we considered only women who
`answered 100% of the survey questions posed; partial inter-
`views were excluded.
`For the Rose survey, responses were analyzed for the entire
`pool of completers and stratified by age (40-44, 45-49, 50-54,
`
`928 Menopause, Vol. 22, No. 9, 2015
`
`ß 2015 The North American Menopause Society
`
`Copyright ß 2015 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.
`
`Page 3 of 11
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`

`

`TRENDS IN USE OF COMPOUNDED HORMONE THERAPY
`
`Harris Survey
`
`Rose Survey
`
`10,781 were
`invited to participate
`
`
`1099 (10%)
`responded
`
`801 were eligible
`completers
`
`
`
`
`
`
`298 were excluded
`
`
`244 ineligible'
`
`
`54 incomplete
`
`
`CHT, compounded hormone therapy.
`'Ineligible because of age or no history of
`menopausal symptoms.
`°lneligible because of age or no history of hormone
`therapy use.
`cQuestion added partway through the Rose survey.
`
`
`
`
`
`
`90,210 were
`invited to participate
`
`
`17,897 (20%)
`responded
`
`17,825 were
`screened
`
`
`
`
`
`
`
`72 men were excluded
`
`15,781 were excluded
`15,456 ineligible"
`
`325 incomplete
`
`
`
`
`
`2044 were eligible
`completers
`
`1771 were asked
`question on CHT"
`
`FIG. 1. Survey sample and disposition for the Harris and Rose surveys.
`
`the survey and 714 were asked about CHT use. The coopera-
`tion rates among eligible women were very high (94% for the
`Harris survey and 86% for the Rose survey), with the number
`of dropoffs in each survey too low to draw meaningful
`conclusions about differences between eligible completers
`and noncompleters.
`Most completers in the Harris and Rose surveys were white,
`had some postsecondary education or vocational training, and
`had public or private healthcare coverage (Table l). Approxi-
`mately three quarters of completers in each survey were
`postmenopausal, having indicated that their last menstrual
`cycle occurred more than 12 months earlier. We considered
`the remaining Harris completers perirnenopausal because all
`had experienced menopausal symptoms. In the Rose survey,
`5% of completers stated that they had just started menopause,
`and 7% stated that they had been going through menopause
`for less than 1 year, these women were considered perime-
`nopausal. Another 15% stated that they had yet to go through
`menopause and were categorized as nonmenopausal. Among
`Rose completers aged 50 to 64 years, 84% were postmeno-
`pausal, 13% were perimenopausal, and 4% had yet to go
`through menopause.
`
`Prevalence, cost, and knowledge of CHT
`We used a four—step process to estimate the prevalence of
`CHT use among US women. In step 1, we calculated the
`estimated number of US women aged 40 years or older who
`are currently using menopausal HT (compounded and FDA—
`approved). First, we determined the rate of current HT use for
`Rose respondents per age range: 40 to 44, 45 to 49, 50 to 54,
`55 to 59, 60 to 69, 70 to 74, 75 to 79, and 80 years or older.
`Next, we multiplied the current use rate for each age range by
`
`the total number of same-age US women per US Census
`Bureau population estimates for 2012 (Table 2).21 This shows
`that approximately 3.7 million US women aged 40 years or
`older currently use HT.
`In step 2, we calculated the number of HT prescriptions
`(compounded and FDA-approved) dispensed annually. We
`multiplied the estimated 3.7 million current HT users by the
`mean number of HT products taken per month in the Rose
`survey (1.7) by the estimated duration of use, which we
`assumed to range from 9 to 12 months. This suggests that
`57 million to 75 million prescriptions for HT are filled
`annually (Fig. 2).
`In step 3, we estimated the number of CHT prescriptions
`dispensed annually. According to PHAST 2.0 prescription
`data, approximately 36 million prescriptions
`for FDA-
`approved HT were filled in 2012; a small percentage may
`have been filled for men and for women younger than 40 years
`(<l%).‘S Subtracting the 36 million annual prescriptions of
`FDA-approved HT from the 57 million to 75 million annual
`prescriptions for all HT indicates that 21 million to 39 million
`prescriptions for CHT may be filled annually, accounting for
`28% to 68% of HT use.
`
`In step 4, we determined the number of US women aged 40
`years or older using CHT annually by dividing the number of
`CHT prescriptions filled annually by the mean 1.7 HT prod-
`ucts taken per month in the Rose survey (1.7) by assumed
`duration of use (9-12 mo). This suggests that 1 million to 2.5
`million women may use CHT annually.
`To calculate the estimated amount spent on CHT annually,
`we multiplied the number of CHT prescriptions filled annu-
`ally by the average price of US$49 that Rose completers
`reported paying out of pocket for HT. Results show that
`
`Menopause. Vol.22, No. 9, 2015 929
`
`Page 4 of 11
`
`Copyright
`
`.
`
`. 2015 The North American Menopause Socnety. Unauthorized reproduction of this article is prohibited.
`
`

`

`PINKERTON AND SANTORO
`TABLE 1. Demographic characteristics of Harris (N¼ 801; 73%)
`and Rose (N¼ 2,044; 11%) completers
`
`TABLE 2. Current rate of HT use among Rose respondents
`extrapolated to an age matched population of US women
`
`Characteristics
`
`Harris survey
`
`Rose survey
`
`Age group (Harris/Rose)
`40 44 y
`45 50/45 49 y
`51 55/50 54 y
`56-59/55-59 y
`60-64 y
`65-69 y
`70-74 y
`75-79 y
`80 y
`Race/ethnicity
`White
`Black
`Hispanic
`Othera
`Highest level of education
`Less than or some high school
`Completed high school
`Vocational training
`Some college (no degree)
`Associate’s degree
`Bachelor’s degree
`Some graduate school
`Graduate degree
`Household income for 2012
`US$<25,000
`US$25,000-49,999
`US$50,000-74,999
`US$75,000-99,000
`US$100,000
`Declined to answer
`Healthcare coverage
`PPO/HMO
`Traditional insurance
`Medicare/Medicaid
`Other/unknown
`No coverage
`Prior hysterectomy
`Menopause status
`Menopausalb
`Perimenopausal
`Nonmenopausal
`
`NA
`208 (26)
`312 (39)
`280 (35)
`NA
`NA
`NA
`NA
`NA
`
`641 (80)
`72 (9)
`72 (9)
`16 (2)
`
`NA
`264 (33)
`NA
`NA
`NA
`449 (56)
`NA
`88 (11)
`
`128 (16)
`168 (21)
`144 (18)
`120 (15)
`216 (27)
`NA
`
`489 (61)
`56 (7)
`88 (11)
`56 (7)
`104 (13)
`160 (20)
`
`278 (14)
`286 (14)
`307 (15)
`287 (14)
`245 (12)
`186 (9)
`145 (7)
`125 (6)
`185 (9)
`
`1,726 (84)
`136 (7)
`99 (5)
`83 (4)
`
`46 (2)
`372 (18)
`94 (5)
`485 (24)
`282 (14)
`434 (21)
`99 (5)
`232 (11)
`
`305 (15)
`599 (29)
`434 (21)
`244 (12)
`335 (16)
`127 (6)
`
`792 (39)
`239 (12)
`752 (37)
`165 (8)
`96 (5)
`927 (45)
`
`601 (75)
`200 (25)c
`NA
`
`1,594 (78)
`259 (12)d
`301 (15)
`
`Data are presented as n (%).
`NA, not available; PPO, preferred provider organization; HMO, health
`maintenance organization.
`aFor the Harris survey, ‘‘other’’ includes Asian American and other. For
`the Rose survey, ‘‘other’’ includes Asian American, Pacific Islander,
`Native American/Alaskan Native, mixed race, and other.
`b‘‘Menopausal’’ refers to women who reported that their last menstrual
`cycle was more than 1 year ago.
`cBecause eligibility for the Harris survey required at least one menopausal
`symptom, women who stated that they had not ceased menstruating for
`1 year or longer were assumed to be perimenopausal.
`dIn the Rose survey, ‘‘perimenopausal’’ refers to women who stated that
`they had been going through menopause for less than 1 year and included
`some women who stated that they had stopped menstruating more than
`1 year ago.
`
`between US$1 billion and US$2 billion may be spent on CHT
`each year in the United States.
`
`Reported prevalence of CHT use
`Two percent (16 of 801) of Harris completers affirmed that
`they had used CHT. Assuming that the 16 CHT users belong
`to the subset of HT ever users (n¼ 123), CHT use would
`account for 13% of the total HT used by Harris completers.
`Twenty-one percent (378 of 1,771) of Rose completers
`
`Age range (y)
`
`Number of
`US women21
`
`Current HT use
`among Rose
`respondents,
`by age (%)
`
`Estimated number
`of US women
`using HT
`
`40-44
`45-49
`50-54
`55-59
`60-64
`65-69
`70-74
`75-79
`80
`Total
`
`10,569,227
`10,962,854
`11,499,014
`10,704,108
`9,279,200
`7,370,497
`5,412,023
`4,198,131
`7,349,650
`77,344,704
`
`7
`7
`5
`3
`5
`3
`3
`3
`5
`
`HT, hormone therapy.
`
`739,846
`767,400
`574,951
`321,123
`463,960
`221,115
`162,361
`125,944
`367,483
`3,744,183
`
`reported current or prior use of personalized CHT, with no
`difference in the rate of CHT use observed among the subset
`of women aged 50 to 64 years (153 of 714). Rates of CHT use
`were higher in the younger age groups and lower in the older
`age groups compared with the overall population of Rose
`completers (Fig. 3). Rose completers taking CHT were more
`than twice as likely as women using conventional HT to
`obtain it through their physician’s office (15% vs 6%, respect-
`ively), although women in both groups were most likely to
`obtain their HT products from a local pharmacy (59% vs 54%,
`respectively; Fig. 4).
`
`Knowledge of CHT
`All Harris completers (N¼ 801) were asked, ‘‘Do you
`believe that bioidentical hormone therapies compounded at
`a specialty pharmacy are FDA-approved?’’ Only 14% cor-
`rectly answered ‘‘no,’’ whereas 10% answered ‘‘yes’’ and
`76% stated that they were not sure (Fig. 5). When Rose
`completers (N¼ 2,044) were asked whether their HT had
`been personalized or compounded for them, 27% of the
`women stated that they did not know.
`
`General findings on menopause symptoms and treatment
`Any HT use
`In the Harris survey, 15% of completers were ever users of
`HT, 6% were current users of HT, and 9% were prior users of
`HT. Patterns of HT use among Rose respondents (n¼ 17,825)
`were similar, with 13% reporting ever use of HT. Approxi-
`mately 5% of Rose respondents were current HT users,
`suggesting that 8% were prior users. In the subset of Rose
`respondents aged 50 to 64 years, 4% were current users and
`6% were prior users. The mean duration of HT use among
`ever users in the Harris survey was 50 months (Fig. 6A). The
`Rose survey expressed duration of use as a range. Based on
`the midpoint for each range, the approximate median use for
`Rose completers was 28 months (Fig. 6B).
`Both surveys showed that HT was generally effective in
`relieving menopausal symptoms. Approximately 89% of ever
`users in the Harris survey stated that HT provided moderate or
`significant relief; 83% of ever users in the Rose survey stated
`
`930 Menopause, Vol. 22, No. 9, 2015
`
`ß 2015 The North American Menopause Society
`
`Copyright ß 2015 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.
`
`Page 5 of 11
`
`

`

`TRENDS IN USE OF COMPOUNDED HORMONE THERAPY
`
`Current HT use rate
`Same-aged women
`
`
`
`per age range
`per US Census
`(see Table 2)
`in the Rose survey
`
`
`
`
`Est. 3.7 million
`Est 9-12 month
`
`Mean 1.7 products
`
`otHTuse
`
`used per month
`US women who X
`HT annuely
`In the Rose survey
`
`
`57-75 milion
`36 million annual
`
`prescriptions for
`FDA-approved HT
`
`EsL 9—12 months
`Mean 1.7 products
`Average $49 cost
`
`of HT use
`
`
`per year
`per product In
`+ used per month
`the Rose survey
`in the Rose survey
`
`
`
`
`1-2.5 mlllon
`51-2 billion spent
`
`
`
`ennuely for CHT
`US women using
`In the Unlted States
`
`CHT per year
`
`
`FIG. 2. Extrapolation of Rose survey data to quantify the annual amount and cost of compounded hormone therapy (CHT) in the United States. HT,
`hormone therapy; Est, estimated; FDA, Food and Drug Administration.
`
`that HT was extremely effective, very effective, or somewhat
`effective.
`
`Most ever users in the Harris and Rose surveys stated that
`their physician had recommended HT (91% and 63%, respect-
`ively). Rose completers were more likely to have received a
`prescription for HT from an ob-gyn than from a general
`practitioner or other types of physician (57% vs 33% vs
`8%, respectively).
`
`Use of nonhormonal treatments
`Harris completers were asked about various nonhormonal
`treatments. Responses showed that 42% of Harris completers
`had tried lifestyle changes (eg, exercise, diet, and stress
`reduction), 26% had tried natural
`therapies and dietary
`supplements (eg, black cohosh, ginseng, and phytoestrogens),
`and 10% had tried nonhormonal prescription medications
`such as gabapentin and antidepressants. More than one third
`of Harris completers never received any treatment of meno-
`pausal symptoms. Most women who had used nonhormonal
`100
`
`treatments stated that the treatments provided moderate to
`significant relief, including 78% of women who made life-
`style changes, 66% of women who tried natural therapies
`and dietary supplements, and 82% of women who used
`nonhormonal prescriptions.
`
`History of menopausal symptoms
`Seventy-eight percent of Harris respondents reported that
`they had experienced or were experiencing menopausal
`symptoms. Almost half (47%) of the women who had experi-
`enced menopausal symptoms were symptomatic at the time
`the survey was taken. Rose completers were not asked directly
`whether they had ever had menopausal symptoms, but the
`survey’s use of adaptive questioning allowed us to determine
`that 15% had no history of symptoms. In both surveys, the
`mean age at menopausal symptom onset was 47 years.
`Harris and Rose completers were asked about specific
`menopausal symptoms and asked to rate symptoms they
`had experienced as mild, moderate, or severe. All completers
`
`219°
`580‘u
`
`370
`
`$60:50a
`
`'640
`
`330
`3"
`E”
`
`”w
`
`0
`
`222121
`
`14
`
`
`iIII
`
`65-69
`
`70-74
`
`75.79
`
`230
`
`40-44
`
`45-49
`
`50-54
`
`55-59
`
`80-64
`
`Mon!
`
`Physician‘s office
`
`nEvermersolCHT(n=37B)
`nEverueersolepprvvedHT(n=917)
`lEverueersoluirknownHUn-Ha)
`
`
`
`
`.
`
` Via the Internet
`
`Loeel pharmacy t
`
`National/regional chain
`(pharmacy/supermarket)
`
`Other/don't Know
`
`0
`
`1o
`
`so
`so
`40
`so
`20
`Rose Complete" Asked About CHT, %
`
`70
`
`FIG. 3. Use of personalized hormone therapy (HT) among Rose com
`pleters, by age (It
`378).
`
`FIG. 4. Sources of hormone therapy (HT) products as self reported by
`women belonging to the subset of Rose ever users questioned about
`compounded hormone therapy (CHT) use (11
`1,771).
`
`Menopause. Vol. 22, No. 9, 2015 931
`
`Page 6 of 11
`
`Copyright
`
`2015 The North American Menopause Sooety. Unauthorized reproduction of this article is prohibited.
`
`

`

`PINKERTON AND SANTORO
`
`76%
`
`Not sure
`
`FIG. 5. Responses of Harris completers (N 801) to the question, ”Do
`you believe that bioidentical hormone therapies compounded at a spe
`cialty pharmacy are FDA approved."
`
`in the Harris survey had experienced menopausal symptoms
`(a requisite for eligibility): 91% ofwomen had a history ofhot
`flashes (of whom 67% described hot flashes as moderate to
`severe), 65% had vaginal dryness, 85% had sleep disturb-
`ance, 48% had urinary complaints, and 48% had sexual
`dysfunction (Fig. 7A).
`When Rose completers (including the 15% who reported
`that they have not yet entered the menopausal transition) were
`questioned about specific menopausal symptoms, 59% of
`women acknowledged a history of hot flashes (of whom
`62% indicated hot flashes to be moderate to severe), 49%
`had experienced vaginal dryness, 66% had sleep disturbance,
`44% had urinary complaints, and 28% had sexual dysfiinction
`(Fig. 7B). In the subset of 1,743 Rose completers considered
`perimenopausal and postmenopausal, 61% reported experi-
`encing hot flashes (of whom 64% considered hot flashes to be
`moderate to severe), 51% had vaginal dryness, 65% had sleep
`disturbance, 45% had urinary complaints, and 29% had sexual
`dysfunction. The experience of menopausal symptoms among
`
`all Rose completers aged 50 to 64 years approached that of the
`overall population in the Harris survey, with similar rates of hot
`flashes (71%), vaginal dryness (59%), sleep disturbance (73%),
`urinary complaints (46%), and sexual dysfunction (35%).
`
`Knowledge of and information on HT
`Most Harris completers (63%) recalled consulting their
`physician about their menopausal sym