2133

ORIGINAL RESEARCH—EPIDEMIOLOGY

Prevalence and Impact of Vaginal Symptoms among

Postmenopausal Women jsm_1335 2133..2142

Nanette Santoro, MD,* and Janne Komi, MD, PhD†

*Albert Einstein College of Medicine, Ob/Gyn & Women’s Health, New York, NY, USA; †QuatRx Pharmaceuticals
Company, Ann Arbor, MI, USA

DOI: 10.1111/j.1743-6109.2009.01335.x

ABSTRACT

Introduction. Vulvovaginal atrophy (VVA) is reported by one-quarter to one-half of postmenopausal women.

Aim. We evaluated the prevalence, inconvenience of, and issues surrounding hormone use for VVA symptoms in
women who were current, past, and never users of menopausal hormone therapy (MHT), along with the relationship
of sexual activity to VVA symptoms.
Methods. An online survey was sent to 3,471 women ⱖ45 years old participating in a panel of approximately 43,000
U.S. adults maintained by Knowledge Networks. Respondents were stratified by MHT use (current, past, and never)
and sexual activity (sexually active and not sexually active). Final respondent data underwent a poststratification
process and Chi-square analysis of hormone use and VVA by sexual activity.
Main Outcome Measures. Percent, calculated as the ratio of response over total responding for each survey question
for all and stratified respondents.
Results. Forty-five percent (1,038/2,290) of respondents (age range 45–89 years; mean 60.7 years) were postmeno-
pausal and currently or previously experienced VVA. Approximately 60% of past or never users of MHT reported
vaginal symptoms; >90% found them bothersome. In comparison, 82% of current users reported VVA symptoms
prior to use. 85% of all respondents were aware of safety issues associated with MHT. The prevalence and perceived
severity of VVA symptoms were substantial but less frequent in nonsexually active women. Analysis of MHT use by
past or current hormone use indicated a trend away from oral dosing and towards patch or vaginal hormones.
Conclusions. Postmenopausal women have a high rate of VVA symptoms. Those who use MHT do so for multiple
reasons—hot flashes, VVA, bone protection, dyspareunia—and most have concerns about long-term safety, despite
the fact that the majority of MHT use was for >5 years. Safety concerns and lack of physician recommendation were
major reasons for not using or discontinuing MHT. Santoro N, and Komi J. Prevalence and impact of vaginal
symptoms among postmenopausal women. J Sex Med 2009;6:2133–2142.
Key Words. Vulvoaginal Atrophy; Menopause; Menopausal Hormone Therapy; Sexual Activity; Vagina; Vaginal
Symptoms

Introduction MHT long term. Hormone therapy concurrently

provided relief of vaginal symptoms (dryness,

M enopausal hormone replacement therapy

(MHT) has been widely prescribed for
well over 50 years to treat the symptoms of estro-
irritation, itching, dyspareunia, and urinary
symptoms) and was believed to provide the addi-
tional benefits of protection against cardiac
gen deficiency in women. Millions of women disease and osteoporosis.
began MHT for vasomotor symptoms (VMS), In 2002, results from the U.S.-based Women’s
such as hot flashes and night sweats that began Health Initiative (WHI) began to change many
with their menopausal transition, and continued physicians’ and patients’ minds about the long-

© 2009 International Society for Sexual Medicine J Sex Med 2009;6:2133–2142

2134 Santoro and Komi

term safety of MHT [1]. For many years there shape the approach to developing better therapeu-
had been an expectation that exogenous estrogen tic options.
would provide long-term cardioprotection, as had Six years after the initial WHI publication, we
been suggested by longitudinal cohort studies [2]. were interested in the prevalence of VVA, how
However, neither the estrogen plus progestin nor bothersome postmenopausal women found the
the estrogen alone arm demonstrated cardiovascu- symptoms of VVA, how living with them affects
lar disease benefit [1,3]. While other risks of their quality of life, their perceptions of the safety of
MHT, including venous thromboembolism and MHT, and what treatments they were using for
breast cancer, had been reported previously [4], VVA and other menopausal symptoms. We
the lack of cardiovascular benefit with MHT designed a survey to specifically evaluate these
resulted in a finding of net harm in the WHI parameters among populations with three different
members who took E + P1 and neither net harm histories of MHT use—those who currently were
nor benefit in women who had had hysterectomies using MHT, those who formerly used MHT but
and took E alone [3]. There has been recent had stopped, and those who never used MHT. To
rethinking of these findings and an appreciation determine the degree to which sexual activity is
that women in the WHI, with a mean age in their linked to VVA symptoms, we looked for differences
early 1960s, are not representative of the age at in the survey results between sexually active and not
initiation of MHT for most symptomatic women sexually active women overall and across the three
[5]. This relatively late initiation of MHT has been groups—current, past, and never MHT users.
hypothesized to be responsible for the lack of car-
diovascular benefit, and there are currently efforts
underway to test the hypothesis that early ini- Methods
tiation of MHT will provide cardioprotection
consistent with prior observational studies [6]. Survey Design and Distribution
Nonetheless, there has been a critical reconsidera- The participants in this population-based study
tion of the usefulness of MHT—even as a short- were drawn from a panel of approximately 43,000
term, symptom-based treatment option, and a U.S. adults in a database actively managed by
reappreciation of the value of lower doses and Knowledge Networks (KN), San Francisco, CA.
nonoral routes of hormone administration. The sample was controlled for gender, age, eth-
Vulvovaginal atrophy (VVA), with its symptoms nicity, education, region, metropolitan area, and
of vaginal dryness, itching, sexual pain, and irrita- Internet use. Results were weighted to reflect the
tion, is strongly and consistently linked to estrogen U.S. Census Bureau Current Population Survey
deficiency and is highly responsive to estrogen (CPS) benchmarks. In return for their participa-
therapy [7]. Similar to VMS, VVA is highly preva- tion, panel members receive Internet access if not
lent in menopausal and perimenopausal women, already on line or points per survey redeemable for
with incidences ranging from 27–59%, depending cash and gifts. The survey was conducted between
upon the exact survey used and population studied March 3rd and 7th, 2008.
[8–12]. The online survey was sent to 3,471 women
However, unlike VMS, which tend to remit ⱖ45 years of age. Of the 66% (2,290/3,471)
over time in the majority of women [13], VVA respondents, 45% (1,038; age range 45–89 years;
symptoms are likely to recur after hormones mean 60.7 years) answered yes to the qualifying
are withdrawn. Thus, for some women VVA question: “Are you postmenopausal and experienc-
symptoms remain a long-term indication for ing, or have experienced in the past, feelings of
treatment. vaginal discomfort, such as dryness, pain, irrita-
Limited data exist in the medical literature tion, itching or similar symptoms?”
addressing the prevalence of vulvovaginal sym- Respondents were stratified by self-reported
ptomatology in postmenopausal women, both sexual activity (sexually active or not sexually
sexually active and not sexually active. Less infor- active, based upon response to the question:
mation has been compiled and published about the “Would you describe yourself and your partner as
bothersomeness of VVA symptoms and attitudes being sexually active?”) and MHT use: current,
about MHT therapy for them. More population- past, and never.
based data about how postmenopausal women Most survey questions were in multiple choice
approach seeking treatment for these symptoms format in which respondents either chose one
and their attitudes toward treatment can help answer or were instructed to check all that applied.

J Sex Med 2009;6:2133–2142

Vaginal Symptoms among Postmenopausal Women 2135

Data Analysis
Final respondent data underwent a poststratifica-
tion process to adjust for variable nonresponse and
noncoverage. Demographic and geographic distri-
butions from CPS and internet penetration from
KN were used as benchmarks. Percents were
calculated on the ratio of response over total
responding for each survey question.
Frequencies of hormone use by type were ana-
lyzed by Chi-square testing among current and past
users, as was frequency of VVA symptoms by self-
reported sexual activity. Percentages differ slightly
from those derived using whole numbers in these
chi-square calculations due to weighting adjust-
ments by KN, but did not affect the overall results.
Figure 1 Survey sample: VVA prevalence and respondent
disposition.
Results
The prevalence of current or past symptoms of
VVA among the 2,290 postmenopausal respon- answered “No” to the original question required
dents was 45% (Figure 1). Approximately half of for entry into the survey could have answered no
the women were sexually active. Results are either because they were not postmenopausal, or
reported for 334 current, 363 past, and 341 never did not have VVA symptoms, it is possible that the
users of MHT [8]. Among the current MHT 45% prevalence of VVA symptoms is slightly
users, 52/334 or 15.6% used vaginal therapy underestimated.
(either cream, pill, or ring) and among the past Across the three groups, the proportion of
MHT users, 23/363 or 6.3% used vaginal therapy. women who reported being sexually active fell
All other current and past MHT users used sys- within the range of 42–57%, with current MHT
temic pills, patches, or gels. Characteristics of the users reporting the highest proportion who were
final sample are shown by MHT history and type sexually active (Table 1; P = 0.0021 for differences
of MHT use (Table 1). Because women who in self reported sexual activity by MHT use).

Table 1 Demographics and history of hormone replacement therapy: qualified respondents (N = 1,038)
Characteristic MHT Use History
Estrogen use status, n Current Past Never All
334 363 341 1,038
Age, mean years (range) 61 62 59 61 (45–89)
Sexually active, n (%)*
Yes 184 (55) 152 (42) 154 (45) 490 (47)
No 148 (44) 206 (57) 184 (54) 538 (52)
No response 2 (0.6) 5 (1) 3 (0.9) 10 (1)
Type of hormone, n**
Oral tablets 231 304 NA 535
Patch 43 26 NA 69
Vaginal cream or tablet 46 22 NA 68
No response 3 6 NA 9
Gel or lotion 5 3 NA 8
Vaginal ring 6 1 NA 7
Race/ethnicity, n (%)†
White 819 (79%)
African American (non-Hispanic) 104 (10%)
Hispanic 87 (8%)
Other 18 (2%)
2+ Races 8 (1%)

*P = 0.0021 for differences in self reported sexual activity by MHT history; **P < 0.0001 for difference in type of hormone used by MHT history; Total may not equal
100% due to rounding.
†
Total ⫽ 1,038 due to weighting.
NA = not applicable.

J Sex Med 2009;6:2133–2142

2136 Santoro and Komi

Figure 2 Current estrogen users:*

82 negative impacts on quality of life prior
to MHT.

Further analysis of the type of hormones used similar to those of past and current users. A total of
by current and past users of MHT indicated a 60% (203/338) reported current symptoms of
significant difference between these two groups VVA including dyspareunia (Figure 3), 59% (120/
(P < 0.0001). Current users were more likely to use 203) used over-the-counter lubricants or moistur-
transdermal or vaginal estradiol than were past izers, and in 31% (63/203), the symptoms went
users, who were overwhelmingly likely to have untreated.
taken estrogen in a pill (83.7% vs. 69.2% past vs. In the past and never used MHT groups, only
current users). Patch and vaginal estrogen use was 7% and 9% respectively of symptomatic post-
approximately twice as frequent in current versus menopausal women reported their VVA symptoms
past users; 12.9% current users used patches and as not bothersome (Figure 4).
13.8% current users used vaginal creams or Bothersomeness and perceived negative impact
tablets, compared to 7.2% and 6.1% of past users, of VVA on quality of life were similar within each
respectively. A small proportion of women re- group whether or not a woman reported being
ported using vaginal rings (1.8% of current vs. sexually active (Figures 2 and 4). Of past users,
0.3% past users); it was not possible to determine 46% (97/209) reported their VVA symptoms to be
from the survey whether the rings delivered sys- moderate or very bothersome. A similar result,
temic, full-dose MHT or local, low-dose vaginal almost 40% (38%; 78/203), was seen among the
therapy.
Bothersomeness and Impact of VVA Symptoms
Of current users, 82% (272/333) reported VVA
symptoms prior to taking MHT and 66% (219/
333) said the symptoms had a negative impact on
their quality of life. This percentage was similar
regardless of whether women identified them- 58 % 60 %
selves as sexually active or not sexually active
(Figure 2).
Of women who were past users of MHT, 58%
(209/360) reported they were currently experienc-
ing symptoms of VVA, including dyspareunia
(Figure 3). More than half, 58% (121/209), were
using over-the-counter lubricants or moisturizers,
but for 38% (78/208) symptoms went untreated.
Most past users (80%, 289/360) had discontinued
MHT therapy >2 years ago and 67% (240/360)
had used MHT for >2 years. Figure 3 Past and never estrogen users: prevalence of
Among respondents who had never used MHT, vaginal dryness symptoms including pain associated with
the prevalence and treatment approaches were sexual intercourse.

J Sex Med 2009;6:2133–2142

Vaginal Symptoms among Postmenopausal Women 2137

Figure 4 Past and never estrogen

users—all, sexually and non-sexually
active: degree of bother from vaginal
dryness and sexual pain.

never users group. This represents a four-choice but 95% (106/112) of them reported that those
response (not, mild, moderate or very) to the concerns included long-term safety. In the past
question: “How bothersome do you find these MHT user group, those who had stopped using
symptoms?” MHT did so as a result of a combination of long-
A large majority of women who had never used term safety concerns (48%; 175/363) and physi-
MHT reported that their physicians had not cians’ advice (36%; 129/363; Figure 5).
suggested MHT for VMS (94%; 288/308), VVA Among postmenopausal women who had never
(83%; 270/325), or other reasons (92%; 283/309). used MHT, 51% (174/341) said they did not start
due to concerns about safety and 38% 1(31/341)
Attitudes by MHT Use History did not start due to concerns about other
All respondents reported some level of concern unwanted adverse effects; 45% (154/341) said
about MHT therapy, especially about long-term their symptoms were not bothersome enough; and
safety. Across all groups, 85% of respondents were 26% (88/341) assumed VMS and VVA symptoms
aware of safety issues associated with MHT use. would go away over time (Figure 5).
They cited physicians, television, and magazines as The reasons women were currently using MHT
the most common sources of this information and (Figure 6) in order of frequency were for relief of
advice. hot flashes (67%; 225/334); relief of vaginal symp-
Current MHT users had a lower percentage of toms (dryness, itching, irritation) (44%; 148/334);
concern about hormone therapy, 34% (112/332), osteoprotection (42%; 141/334); and relief of dys-

J Sex Med 2009;6:2133–2142

2138 Santoro and Komi

Figure 5 Past and never estrogen

users: reasons for stopping or not
starting MHT.

pareunia (19%; 64/334). A total of 70% (233/334) 438 Australian-born women included 172 women
of current users had been taking MHT for more who transitioned from premenopausal to post-
than 5 years and most of them, 67% (222/329), menopausal over the course of 7 years. For this
planned to continue until their doctors advised cohort, the prevalence of vaginal dryness pro-
them to stop. gressed from 4% in early perimenopause to 21%
in late perimenopause to 47% by 3 years after the
final menstrual period. Severity, as assessed by the
Discussion
geometric mean of symptom scores by menopausal
Our finding of a 45% prevalence rate of VVA status, demonstrated a significant increase for
among a large sample of women ⱖ45 years of age vaginal dryness (P < 0.001) across the transition.
confirmed that symptoms of VVA, including dys- The prevalence of VVA in our study and others
pareunia, are common among postmenopausal is somewhat higher than results from the WHI
women. The reported prevalence in our study is in cohort [11], which at baseline reported a 27%
agreement with prevalence rates reported in the prevalence of vaginal or genital dryness and an
literature over the past several years. 18.6% prevalence of vaginal or genital irritation
A 1996 survey questionnaire of 1,280 61-year- or itching. The WHI study population included
old postmenopausal women in Uppsala County 98,705 women, 56% of whom participated only in
Sweden found that 43% reported trouble with the observational study and 44% of whom partici-
vaginal dryness [9]. pated in one of the three clinical trials. It is
In 2000, a longitudinal population-based study possible that the lower prevalence of vaginal symp-
tracked the progression of vaginal dryness, among toms in this study reflects less overall symptoma-
other symptoms, over time [10]. The population of tology in the clinical trial participants, who had

Figure 6 Current estrogen users;

reasons for using MHT.

J Sex Med 2009;6:2133–2142

Vaginal Symptoms among Postmenopausal Women 2139

to be willing to agree to discontinue MHT terns because 84% of past MHT users took pills,
in order to undergo randomization. Thus, such but only 69% of current users reporting taking
women would be expected to be less likely to suffer pills, reflecting a trend toward lower doses and
from severe VVA. nonoral dosing. In particular, transdermal estradiol
In addition to these large epidemiological and vaginal preparations nearly doubled in fre-
series, several large surveys focusing on women’s quency of use, although both remain low compared
menopausal symptoms have reported on the to overall pill use. Our data did not include infor-
prevalence rates of VVA. In a 2007 internet survey mation on dose or other specifics of the hormone
of postmenopausal women over 45 years of age, regimen but seem to indicate change in prescribing
32% (505/1601) reported “experiencing feelings trends for MHT. Recent studies suggest that both
of vaginal discomfort, such as dryness, pain, irrita- vaginal and oral estrogen are similarly effective in
tion, itching or similar symptoms” [12]. alleviating vaginal symptoms and improving sexual
In a series of on-line interviews on how function [15]. Others suggest that menopausal
menopausal symptoms impact women’s lives, hormone therapy improves sexual thoughts and
(N = 1054; ⱖ35 years), of the 81% of women who feelings, but does not necessarily increase the
reported experiencing menopausal symptoms, amount of sexual activity [16].
59% had some type of vaginal symptoms, i.e., In general, the group that had never used MHT
dryness, pain during active sex, vaginal atrophy, seemed to have been less influenced by physicians,
and increased urinary infection. Among those reporting that they had heard about safety con-
reporting vaginal atrophy, the great majority, 88%, cerns (checking all that applied) most often from
considered this symptom of menopause to be “at magazines (59%), followed by television (50%),
least somewhat problematic” [13]. newspapers (41%), and least of all by physicians
A 2008 internet survey of sexually active post- (40%). Notably, up to 94 % said physicians had
menopausal women (N = 1,480) addressed the not suggested MHT for VMS, VVA, or other
relationship between female sexual dysfunction reasons. Taken together, these findings imply that
(FSD) and VVA [14]. The prevalence of VVA in this the concerns about MHT use among this group
sample was 57%. As for the association between may have been influenced by other than medical
FSD and VVA, the study reported that 40% of the advice. The past MHT user group listed physi-
population had both conditions, that women with cians and television equally as sources of informa-
FSD were 3.84 times more likely to have VVA, and tion (approximately 58%), whereas 68% of current
that treating one may treat the other. users had heard about safety concerns from their
We looked across three groups stratified by physicians. Thus, for current users, who are typi-
history of MHT use for both expected and unex- cally seen annually for prescription renewals, phy-
pected differences. Not surprisingly, past, and sician interaction provided the most information.
never MHT users appeared to have a somewhat When asked to select from a list of reasons for
greater overall concern about the safety of hor- never using MHT, 26% of never users of MHT
mones, 48% and 51%, respectively. This was in assumed that menopausal symptoms, whether
contrast to 34% of current users, although almost VMS or VVA, would go away in time. This mis-
all of the current users with concerns about MHT conception indicates inadequate education about
had long-term safety concerns. Despite the long menopausal symptoms and a possible detriment of
term safety concerns of a third of the MHT users, a lack of physician contact in this group of women.
70% had been using MHT for more than 5 years A recently published meta-analysis of available evi-
and 67% planned to continue until advised by dence found a median duration of VMS of 4 years
their physicians to stop. among symptomatic women [17]. Thereafter,
Women who had never used hormones appeared symptoms subsided for most women. In contrast,
to be more worried about unwanted side effects; VVA is not known to subside over time, clearly
38% listed this as their reason for not using MHT, worsens across the menopause, and for many
suggesting that the anticipation of adverse effects women remains a problem into their 1960s and
was a deterrent to initiating MHT. Only 10% of 1970s [11]. In the WHI cohort, the frequency
past users indicated experiencing side effects as a of self-reported baseline urogenital symptoms
reason for stopping MHT use. Many said they had (vaginal dryness, discharge, and dysuria) did not
stopped because of concerns for long-term safety meet the criteria for meaningful differences across
(48%) and their physicians’ advice (35%). We the 10-year age bands of 50–59, 60–69, and 70–79
observed evidence of change in prescribing pat- years of age. Recent trends toward lower doses and

J Sex Med 2009;6:2133–2142

2140 Santoro and Komi

exclusively vaginal routes of administration of strated promise in a recently reported phase-III

MHT may help assuage women’s fears and con- clinical trial [23–25]. More research continues to
cerns about the longer term treatment required to be needed into new treatments that are effective
address VVA. and free of the safety concerns surrounding long-
In our study the three groups stratified by term MHT.
MHT use included similar percentages of sexually Our survey results reveal a large proportion of
and not sexually active women who currently were women suffering from untreated or only episodi-
experiencing, or had in the past experienced, the cally treated VVA symptoms. Among the 704 past
symptoms of VVA (Figures 1 and 3) although past and never MHT users, 59% reported current VVA
and never users reported being sexually active less symptoms and 92% found them mildly to very
frequently. We conclude that VVA symptoms bothersome (Figure 4). Although we did not
clearly occur both in the presence and absence capture sufficient information in this survey on the
of sexual activity and are similarly bothersome perceived effectiveness of over-the-counter rem-
regardless of sexual activity status. This finding is edies such as vaginal moisturizers and lubricants,
in sharp contrast to two common misconceptions: the striking similarity of the prevalence of VVA
that only sexually active women are seriously both- symptoms in all groups of women regardless of
ered by the symptoms of VVA and that continued sexual activity and past or never MHT use argues
sexual activity is protective against the symptoms that these remedies are not effective. Of those
of VVA. These misconceptions may mean that cli- using over-the-counter lubricants or moisturizers,
nicians often overlook the possibility of clinically 59% reported VVA symptoms including dyspareu-
significant VVA, especially in women who are not nia. Evidently, these agents were not providing
sexually active. sufficient relief, given the level of bothersomeness
A major 2007 study of sexuality and health reported. It is also possible that the women were
among older adults [18] included 1550 women, 57 not using these treatments in an ideal fashion,
to 85 years of age. Among women aged 57–64 accounting for their apparent ineffectiveness. Of
years, 61% were sexually active, compared to the other past and never MHT users with VVA
39.5% aged 65–74 years and 16.7% aged 75–85 symptoms, 34% did not treat their symptoms,
years. Although this was an older population than despite finding them bothersome.
we surveyed, the numbers support our finding that Our study has some strengths and some limita-
about half of postmenopausal women are sexually tions. The completion of an Internet based survey
active. on such a topic might be expected to improve the
It has been widely accepted that continued honesty of the responses, since women could com-
sexual activity is protective against VVA symptoms plete the survey in the privacy of their homes. The
[19]. Indeed, as discussed by Pastore, et al. [11], representativeness of the sample is reasonable
the researchers in the WHI had supposed that because of the broad reach of the Internet;
sexual activity would protect against vaginal however, women without Internet access, who
dryness but found that not to be the case. Our tend to be poorer and less educated, were not
findings that substantial percentages of both sexu- represented in this study. The need to limit the
ally active and inactive women reported VVA length of the survey resulted in less detail about
symptoms argues against the notion of sexual patterns of hormone use, compliance with
activity as protective against VVA. hormone use, specific aspects of vulvovaginal
Other than MHT, there are currently no FDA- symptoms and their possible relationships to dif-
approved remedies for VVA. Most evaluations of ferent hormone regimens, and specific aspects of
nonhormonal pharmaceutical or natural therapies sexual function or dysfunction linked to VVA.
for the symptoms of menopause have focused on Moreover, it is possible that women in each of our
relief of VMS [20–22]. The drug class of selective hormone use groups have a different overall expe-
estrogen-receptor modulators (SERMS) has been rience of symptom severity, i.e., it is likely that
investigated for treatment of certain estrogen- current users continue to do so because they have
deficiency related conditions, such as the use of more severe symptoms. Because no direct contact
raloxifene for osteoporosis. Each member of this with participants was involved, we were unable to
ever-growing class of drugs has a distinctive profile verify the self-reported findings against a physical
of activity based on its molecular mechanisms of examination. Despite these limitations, we have
action at the cellular and tissue levels. For VVA produced data that are in general agreement with
symptoms, the SERM ospemifene has demon- the published literature in this area and extend

J Sex Med 2009;6:2133–2142

Vaginal Symptoms among Postmenopausal Women 2141

information about VVA to include perceptions 2 Stampfer MJ, Colditz GA, Willett WC, Manson JE,
about the effectiveness, safety, and tolerability of Rosner B, Speizer FE, Hennekens CH. Postmeno-
MHT. pausal estrogen therapy and cardiovascular disease.
In summary, our results confirm a high preva- Ten year follow-up from the nurses’ health study. N
Engl J Med 1991;325:756–62.
lence of VVA among postmenopausal women,
3 Anderson GL, Limacher M, Assaf AR, Bassford T,
sexually active and not sexually active, resulting in Beresford SA, Black H, Bonds D, Brunner R,
symptoms such as vaginal dryness and dyspareunia, Brzyski R, Caan B, Chleboweski R, Curb D, Gass
which most women report as bothersome. Post- M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J,
menopausal women who discontinued or never Hubbell A, Jackson R, Johnson KC, Judd H,
used hormone therapy did so due to safety con- Kotchen JM, Kuller L, LaCroix AZ, Lane D,
cerns, physician advice (or lack thereof), and other Langer RD, Lasser N, Lewis CE, Manson J, Marg-
unspecified concerns. Those women who currently olis K, Ockene J, O’Sullivan MJ, Philips L, Prentice
take MHT do so for multiple reasons—VMS, VVA, RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G,
bone protection, dyspareunia—but many have con- Stefanick ML, Van Horn L, Wactawski-Wende J,
cerns about long-term safety, despite most having Wallace R, Wassertheil-Smoller S. Women’s Health
Initiative Steering Committee. Effects of conjugated
been on hormone therapy for longer than 5 years.
equine estrogen in postmenopausal women with
Corresponding Author: Nanette Santoro, MD, Divi- hysterectomy: The Women’s Health Initiative ran-
sion of Reproductive Endocrinology, Albert Einstein domized controlled trial. JAMA 2004;291:1701–12.
College of Medicine, 1300 Morris Park Avenue, Mazer 4 Colditz GA, Hankinson SE, Hunter DJ, Willett
314, Bronx, NY 10461, USA. Tel: 718-430-3512; Fax: WC, Manson JE, Stampfer MJ, Hennekens C,
718-430-8586; E-mail: [email protected] Rosner B, Spetzer FE. The use of estrogens and
progestins and the risk of breast cancer in post-
Conflict of Interest: Dr. Santoro is a past consultant to menopausal women. N Engl J Med 1995;332:1589–
QuatRx Pharmaceuticals Company. Dr. Komi is an 93.
employee of QuatRx Pharmaceuticals Company. 5 Rossouw JE, Prentice RL, Manson JE, Wu L, Barad
D, Barnabei VM, Ko M. LaCroix AZ, Margolis KL,
Stefanick ML. Postmenopausal hormone therapy
Statement of Authorship and risk of cardiovascular disease by age and years
since menopause. JAMA 2007;297:1465–77.
Category 1
6 Harmon SM, Brinton EA, Cedars M, Lobo R,
(a) Conception and Design Manson JE, Merriam GR, Miller VM, Naftolin R,
Nanette Santoro; Janne Komi Santoro N. KEEPS; The Kronos early estrogen
(b) Acquisition of Data prevention study. Climacteric 2005;8:3–12.
Nanette Santoro; Janne Komi 7 Santoro N, Sherman S. New interventions for
(c) Analysis and Interpretation of Data menopausal symptoms. Bethesda, MD: National
Nanette Santoro; Janne Komi Institutes of Health, US Dept of Health and Human
Services; 2006.
Category 2 8 Santoro N, Komi J. High prevalence and impact of
(a) Drafting the Article vaginal symptoms among postmenopausal women.
Nanette Santoro; Janne Komi North American Menopause Society Meeting,
(b) Revising It for Intellectual Content Orlando, September 24–27, 2008, Abstract/Poster
Nanette Santoro; Janne Komi P-51.
9 Stenberg A, Heimer G, Ulmsten U, Cnattingius S.
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