Empowering the vaginal atrophy dialogue multi_therapeutic2

Empowering the Vaginal
Atrophy Dialogue

Faculty/Presenter Disclosure
 Faculty: Dr. Unjali Malhotra
 Relationships with commercial interests:
 Grants/Research Support: none
 Speakers Bureau/Honoraria: Bayer, Merck, Pfizer,
Novo Nordisk
 Consulting Fees: Pfizer
 Other: none

Disclosure of Commercial Support
 This program has received financial support from
Novo Nordisk in the form of an educational grant
 Potential for conflict(s) of interest:
 Dr. Unjali Malhotra has received an honorarium from
Novo Nordisk whose product(s) are being discussed in
this program
 Novo Nordisk distributes, licenses a product that will be
discussed in this program: Estradiol 10 μg (Vagifem® 10)

Mitigating Potential Bias
 Material was developed and reviewed by
independent third-party experts who were
responsible for vetting the program’s needs
assessment results and subsequent content
development to ensure accuracy and fair balance

Learning Objectives
 After this session, participants will be able to:
 Describe the prevalence and pathophysiology of
vaginal atrophy
 Discuss women’s attitudes about vaginal atrophy
 Examine the effects of vaginal atrophy and its treatment
on intimate relationships
 Manage vaginal atrophy using the latest treatment
recommendations
 Counsel post-menopausal women about vaginal
atrophy and treatment options

Pre-Test Questions
1. In vaginal atrophy :
A. Vaginal pH decreases
B. Blood flow is maintained
C. Parabasal cells predominate in the epithelium
D. Inflammation is always absent

Pre-Test Questions
2. Post-menopausal Canadian women:
A. Have a good understanding of vaginal atrophy and its
associated symptoms
B. Are aware of the chronic nature of the condition
C. Are likely to use over-the-counter products before
discussing symptoms with their physicians
D. More than 40% would be willing to use local vaginal
estrogen to treat vaginal atrophy symptoms
E. All of the above
F. C and D

Pre-Test Questions
3. Local estrogen therapy:
A. Effectively manages symptoms
B. Reverses atrophic changes
C. Has a positive impact on intimate relationships
D. All of the above
E. A and B

Pre-Test Questions
4. How comfortable are you discussing
treatment options for vaginal atrophy with
post-menopausal women?
A. Very uncomfortable
B. Somewhat uncomfortable
C. Somewhat comfortable
D. Very comfortable

Prevalence of Vaginal Atrophy
 Up to 75% of menopausal women may experience vaginal
atrophy symptoms1,2
 Approximately 50% of post-menopausal women have vaginal
atrophy symptoms that impact on sexual function and quality of
life3
 Despite its prevalence, vaginal atrophy is often not recognized
by women as a chronic condition
 1/3 will not seek medical advice3
 The taboo status surrounding vaginal atrophy means that many
women do not receive effective treatment
1. The North American Menopause Society. Menopause. 2007;14:357-369.
2. Labrie F, et al. Menopause. 2009;16:907-22.
3. Nappi RE, Kokot-Kierepa M. Climacteric. 2012;15:36-44.

IMS Recommendations: Background
Post-menopausal vaginal atrophy:
A common cause of distressing symptoms due to
estrogen deficiency
Poorly recognized by healthcare professionals
Should be diagnosed and treated promptly to avoid
cascade of events that do not resolve spontaneously
IMS, International Menopause Society.
Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Vaginal Atrophy Pathophysiology:
Effects of Declining Estrogen
 Vaginal epithelium becomes thinner, vaginal
rugae diminish
 Vaginal wall appears smoother
 Colonization of the vagina by lactobacillus
decreases
 Vaginal pH rises above 6
 Blood flow is reduced
 Vagina has pale appearance and may contain
small petechiae and/or other signs of inflammation

Vaginal Atrophy: Pathophysiology
Johnston SL. Geriatrics & Aging. 2002;5(7):9-15.
Vaginal environment before menopause Vaginal environment after estrogen loss
Ovaries produce less estrogen
(or none at all)Ovaries produce estrogen
The vaginal lining is thick and moist The vaginal lining becomes thin and dry
There is
decreased blood
flow to vaginal
tissues
There is good blood
flow to vaginal
tissues
Vaginal walls are elastic
Vaginal fluid is secreted during sexual activity
Vaginal elasticity decreases
There is less secretion of fluids during
sexual activity
The vagina narrows and shortens

Vaginal Atrophy Pathophysiology:
Cellular Changes
Thick, healthy,
well-estrogenized
lining of the vagina
in premenopausal women
Thin, dry lining of vagina
due to menopause
(after estrogen loss)
superficial
parabasal
intermediate
The North American Menopause Society. Menopause. 2007;14:357-69.
After menopause, there is an increase in
parabasal and intermediate cells and a
substantial decrease in superficial cells
Intermediate and superficial cells
predominate in premenopausal
women; minimal parabasal cells

Discussion Question
 What do post-menopausal Canadian women know
about vaginal atrophy?

Viva Survey Results: What Do Post-menopausal
Canadian Women Know About Vaginal Atrophy?
 Most women thought vaginal dryness, itching,
burning, soreness, or pain during intercourse were
merely symptoms of menopause
 Only 7% of Canadian women associated these
symptoms with vaginal atrophy
VIVA, Vaginal Health: Insights, Views & Attitudes.
Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

VIVA Survey Results: How Many Women
Experience Symptoms of Vaginal Atrophy?
50% of Canadian women experienced vaginal symptoms
59% rated these symptoms as moderate or severe

Discussion Question
Which of the following is not a symptom of
vaginal atrophy?
A.Dryness
B.Incontinence
C.Pain during intercourse
D.Itching
E.Vaginal discharge
F.All are symptoms of vaginal atrophy

Recognizing the Symptoms of
Vaginal Atrophy
 The most common vaginal atrophy symptoms reported in
the IMS recommendations1
are the same as those reported
by women in the VIVA survey2
 Dryness (estimated 75%)1
 Dyspareunia (estimated 38%)1
 Vaginal itching, discharge, pain (estimated 15%)1
 Urinary symptoms associated with vaginal atrophy:1
 Dysuria, nocturia, and urgency
 Urinary incontinence
 Recurrent urinary tract infections
IMS, International Menopause Society. VIVA, Vaginal Health: Insights, Views & Attitudes.
1. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

VIVA Survey Results: Which Symptoms of Vaginal
Atrophy Do Canadian Women Experience?
Dryness was by far the most commonly experienced symptom
of vaginal atrophy

In Her Own Words…
About Her Symptoms
Play video
Joan Boone
TRANSCRIPT OF VIDEO CLIP: “Vaginal atrophy has so many symptoms, but not every woman has
every symptom. The ones I had were dryness, a loss of natural moisturizer; I had painful intercourse,
and I had really just the driest feeling, so it was uncomfortable.”

Discussion Question
 How does vaginal atrophy impact the lives of

IMS Recommendations: Be Aware That
Women Are Suffering in Silence
 Women are often reluctant to consult/complain about
vaginal atrophy, and they may feel their doctors are also
uninterested or uncomfortable talking about this issue1,2
 The Canadian cohort of the VIVA survey also
demonstrated this3
3. Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]
“We don’t have a pink Viagra for women,” says Dr. Rossella Nappi.
“… maybe it’s less easy to treat VA because it’s easy to speak about
ED, and it’s not so easy to talk about VA. We should talk about ED
and VA together for a better life of the couple.” ZOOMER Magazine, March 2013

Canadian Women Are Suffering in Silence
 52% of women with
vaginal atrophy waited
≥6 months before seeing
a healthcare provider
 56% of women
experiencing vaginal
atrophy had symptoms
≥3 years
Length of time women experienced
symptoms of vaginal discomfort

CLOSER Survey Results: Effects of Vaginal
Atrophy on How a Woman Feels About Herself
 51% of women felt upset that their body doesn’t work
as well anymore
 41% of women felt they had lost their youth
 33% of women were concerned that vaginal atrophy
would never go away
 27% women had lost confidence in themselves
as a sexual partner and no longer felt
sexually attractive
CLOSER, CLarifying Vaginal Atrophy’s Impact On SEx and Relationships.
Nappi RE. European Menopause and Andropause Society (EMAS) Annual Congress, March 2012.
Gingras L, et al. SOGC 68th
Annual Conference. June 2012. Poster 486.

58%
49%
35%
23%
62%61%
28%
14%
22%
76%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Less sex Less satisfying
sex
Put off having
sex
Stopped
having sex
altogether
Avoided
intimacy
Respondents,%
Women
Men
CLOSER Survey: Effects of Vaginal Discomfort
on Intimate Relationships (Canadian Data)

VIVA Survey Results: Who Would Canadian
Women Turn to if They Experienced Vaginal
Discomfort?
 60% of women were comfortable discussing
vaginal atrophy with their doctor
 72% of Canadian women would talk to their
primary care physician if they experienced vaginal
discomfort
 30% would speak to their gynecologist
The Physician-Patient conversation about
vaginal atrophy needs to be routine

Discussion Question
 How would you start the vaginal atrophy
conversation?

IMS Recommendations:
Getting the Conversation Started
 Talk about vaginal dryness since patients may be reluctant to
do so1
 Consider that relationship/sexual issues may present as
vaginal discomfort1
 In the CLOSER Survey, 27% of Canadian women said vaginal
atrophy made them lose confidence in themselves as a sexual
partner2
 Remember that women using systemic estrogen can still
develop vaginal atrophy symptoms1
 Some urinary symptoms occur concurrently with vaginal
atrophy and also respond positively to vaginal estrogen
therapy1
2. Gingras L, et al. SOGC 68th

Getting the Conversation Started
 Ask questions such as:
 “Around the time of menopause, some women may
experience vaginal dryness, which may make intercourse
uncomfortable. Have you noticed this type of change?”
 Be sensitive to the presence of an able sexual partner
 “Are you bothered by vaginal itching or vaginal burning?”
 “Have you noticed a change in vaginal discharge?”
 “Do you sometimes or often have vaginal yeast infections?”
 “Do you sometimes or often have urinary tract infections?”
 “Have you ever taken any vaginal lubricants or moisturizers
to relieve vaginal dryness or itching?”

VIVA Survey Results: Canadian Women More Likely to
Use OTC Products Than Treat Underlying Cause
HRT, hormone replacement therapy. OTC, over-the-counter. VIVA, Vaginal Health: Insights, Views & Attitudes.

IMS Recommendations and
VIVA Survey: Treatment Options
 Women need to be informed about effective
treatment options for vaginal atrophy1
 VIVA survey data revealed women’s lack of
knowledge about treatment options
 Close to 1 in 10 women believed there is no effective
treatment for vaginal discomfort2
 In Canada, 42% of women were unaware of local
estrogen treatments3
3. Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

VIVA Survey Results: Canadian Women Willing
to Try Effective Treatment That Maintains
Normal Hormone Levels
 Only 32% would consider systemic hormone replacement
therapy
 43% were willing to try local estrogen treatment (LET)
 24% undecided about using LET
 65% Canadian women did not expect return to the vagina
of their youth, but would welcome greater comfort

Discussion Questions
 What are the available treatment options for
vaginal atrophy?

IMS and SOGC Recommendations:
Vaginal Moisturizers and Lubricants
Vaginal lubricants
May be recommended for subjective symptom improvement of dyspareunia
(Level IIIC evidence)1
Do not reverse vaginal atrophy1
Are non-physiological2
Give temporary symptom relief, often followed by vaginal irritation2
Vaginal moisturizers
Polycarbophil gel is an effective treatment for symptoms of vaginal atrophy,
including dryness and dyspareunia (Level IA evidence)1
Improve lubrication2
Do not reverse vaginal atrophy3
Are less effective than topical estrogen therapy2
Are useful for women who cannot take hormones2
IMS, International Menopause Society. SOGC, Society of Obstetricians and Gynaecologists of Canada.
1. Society of Obstetricians and Gynaecologists of Canada. J Obstet Gynaecol Can. 2009;31(1 Suppl 1):S27-S30.
3. Bélisle S, et al; Menopause Guidelines Committee. J Obstet Gynaecol Can. 2006;28(2 Suppl 1):S7-S94.

IMS Recommendations: Principles of
Local Estrogen Therapy
 Restore urogenital physiology1-3
 Estrogen therapy lowers vaginal pH, thickens the epithelium,
increases blood flow, improves vaginal lubrication1
 Alleviate symptoms1-3
 Most women will obtain substantial relief from their
symptoms after about 3 weeks of treatment1
 Some women may require 4–6 weeks before adequate
improvement is observed1
 These principles are also supported by NAMS and SOGC2,3
IMS, International Menopause Society. NAMS, North American Menopause Society. SOGC, Society of Obstetricians and Gynaecologists of Canada.
2. North American Menopause Society. Menopause. 2007;14(Pt 1):357-69.
3. Bélisle S, et al; Menopause Guidelines Committee. J Obstet Gynaecol Can. 2006;28(2 Suppl 1):S7-S94.

 Local estrogen therapy is preferable for vaginal atrophy when
systemic treatment is not needed for other reasons
 Systemic and local therapy may be initially required for some
women
 Local therapy avoids most systemic adverse events and is
probably more efficacious for vaginal problems
Vaginal cream with applicator Intravaginal ring
Vaginal tablet with applicator

SOGC Recommendations:
SOGC Clinical Practice Guidelines
Conjugated estrogen cream, an intravaginal
sustained-release estradiol ring, or estradiol vaginal
tablets can be recommended as effective
treatment for vaginal atrophy (Level IA)
Vaginal estrogen therapy can be recommended for
the prevention of recurrent urinary tract
infections in post-menopausal women (Level IA)
SOGC, Society of Obstetricians and Gynaecologists of Canada.
Society of Obstetricians and Gynaecologists of Canada. J Obstet Gynaecol Can. 2009;31(1 Suppl 1):S27-S30.

Vaginal Atrophy Treatment: Local
Estrogen Therapies Available in Canada
Formulation Vaginal Tablet Vaginal Cream Vaginal Ring
Estrogen type
(trade name)
Estradiol 10 μg
(Vagifem®
10)1
Conjugated estrogens
0.625 mg/g (Premarin®
)2
Estrone 0.1%
(Estragyn®
)3
17 ß-Estradiol 2 mg
(Estring™)4
Dose • 1 vaginal tablet • Start at 0.5 g daily dose
strength
• Dose adjustments (0.5
to 2 g) may be made
based on individual
response
• 2.0 to 4.0 g per
day
• 1 ring/3 months
Dosage • Initial: daily for 2 weeks
• Maintenance: twice a
week with a 3-4 day
interval between doses
• Daily for 21 days, then 7
days off
• Daily for 25 days,
then 5 days off
• 1 ring should remain
inserted in the vagina
for 90 days
Administration • Each tablet is in a pre-
loaded applicator ready
to be inserted into the
vagina
• Cream needs to be squeezed into the
applicator and dose measured prior to
administration
• 1 ring inserted into
the vagina
1. Vagifem®
10 product monograph. 2010. 2. Premarin®
product monograph. 2012. 3. Estragyn®
product monograph. 2011; 4. Estring™ product monograph. 2009.
5. Sturdee DW, Panay N. Climacteric. 2010;13:509-22. 6. Rioux JE, et al. Menopause. 2000;7(3):156-61. 7. Ayton RA, et al. Br J Obstet Gynaecol. 1996;103(4):351-8.
 All local estrogen preparations are effective5
 Patient preference usually determines treatment used5
 Patients prefer vaginal tablets and rings over cream6,7

Local Estrogen Therapy:
Effect on Vaginal Epithelium
Improvement in vaginal epithelium maturation
LOCF, last observation carried forward.
Simon J, et al. Obstet Gynecol. 2008;112(5):1053-60.
*
*
**
* **
* * *
*
* * * *
*
*
*p<0.001 10 µg estradiol vs. placebo. **p=0.007 10 µg estradiol vs. placebo.
Placebo 10 µg Estradiol 2

Effect on pH
pH <5 = grade 0 (no vaginal atrophy)
pH 5–5.49 = grade 1 (mild vaginal atrophy)
pH 5.5–6.49 = grade 2 (moderate vaginal atrophy)
pH >6.49 = grade 3 (severe vaginal atrophy)
P-values describe comparisons of the change from baseline between treatment groups.
LOCF, last observation carried forward.
1. Vagifem®
10 product monograph. 2010.
2. Simon JA, et al. 18th Annual Meeting of the North American Menopause Society (NAMS). 2008.
Improvement (lowering) of vaginal pH

Effect on Vaginal Health
Grading vaginal health
Evaluations of:
 Vaginal secretions
 Epithelial integrity
 Epithelial surface thickness
 Vaginal colour
 Vaginal pH
Coded on 4-point scale:
 No atrophy = 0
 Mild atrophy = 1
 Moderate atrophy = 2
 Severe atrophy = 3

Effect on Vaginal Health
LOCF, Last observation carried forward.
Improvement in vaginal health
p<0.001
p<0.001
p<0.001 p<0.001
p<0.001

Effect on Bothersome Symptoms
p=0.053
p=0.014 p=0.003 p=0.004
LOCF, Last observation carried forward.
Change in most bothersome symptom score
0.0
0.5
1.0
1.5
2.0
2.5
Baseline 2 4 8 12 (LOCF) 52 (LOCF)
Meanscore
Mostbothersomesymptom
Weeks
Placebo 10 µg Estradiol 2

Local Estrogen Therapy: Effects on Sex
Life (CLOSER Survey, Canadian Data)
 Canadian women with vaginal atrophy reported that
since starting local estrogen therapy:
 Sex was less painful (58%)
 Sex was more satisfying for them personally (43%)
 They were more optimistic about the future of their sex life
(33%)
 Their sex life had improved (32%)
 Canadian men reported that since their partner started
local estrogen therapy for vaginal atrophy:
 Sex was less painful (58%)
 They look forward to having sex (59%)

Local Estrogen Therapy: Effects on Sex
Life (CLOSER Survey, Canadian Data)

In Her Own Words…
About Her Treatment
Play Video
Joan Boone
TRANSCRIPT OF VIDEO CLIP: “I find that it’s treated all my symptoms, it’s improved my vaginal health,
it’s improved my home life with my husband because I’m not having the same kind of problems that I
was previously.”

For Discussion
Which of the following conditions is not a
contraindication for treatment with local
estrogen therapy?
A.Undiagnosed vaginal/uterine bleeding
B.Interstitial cystitis
C.Known or suspected endometrial cancer
D.Other hormone-sensitive cancers

Contraindications
 Treatment is contraindicated in patients with:
 Undiagnosed vaginal/uterine bleeding
 Known or suspected endometrial cancer
 Other hormone-sensitive cancers

Adverse Effects
 Few adverse events
 Vaginal discharge, itching, irritation, and pelvic pain may be
more common with creams
 Systemic effects are uncommon
 Endometrial hyperplasia and breast tenderness may be
more common with creams
 Women need to report vaginal bleeding and breast
tenderness, as these side effects are not anticipated with
low-dose vaginal therapy

Local Estrogen Therapy (LET):
Adverse Effects (cont’d)
 No evidence of increase in VTEs with use of LET1
 No evidence of increase in metastases in breast cancer
survivors using LET1
 For women with a history of hormone-dependent cancer:
 Management should depend on patient preference in
consultation with oncologist2
 For women treated for non-hormone-dependent cancer:
 Management of vaginal atrophy is similar to that for women
without a cancer history2
 Data insufficient to recommend annual endometrial
surveillance in asymptomatic women2
VTE, venous thromboembolism.
2. The North American Menopause Society. Menopause. 2007;14:357-69.

Is Progestin Required?
SOGC Clinical Practice Guidelines:1
Routine progestin co-therapy is not required for endometrial
protection in women receiving vaginal estrogen therapy in
appropriate dose (IIIC)
IMS recommendations:2
Conjugated estrogen and estradiol vaginal preparations may
stimulate the endometrium in a dose-related manner
Appropriate use of low doses of local estrogen does not
require additional progestin for endometrial protection
IMS, International Menopause Society. SOGC, Society of Obstetricians and Gynaecologists of Canada.
1. Society of Obstetricians and Gynaecologists of Canada. J Obstet Gynaecol Can. 2009;31(1 Suppl 1):S27-S30.

Treatment Duration
 There are no guidelines for therapy duration1
 There are limited data on use of local estrogen beyond 6 months
 Symptoms commonly return when treatment is
discontinued1
 If long-term therapy is going to be implemented, low-dose
therapy should be used1
 Women need to be informed that long-term treatment may
be needed1
 In the VIVA survey, more than 6 in 10 women did not know that
vaginal atrophy is a chronic condition2
 Treatment failure should mandate further evaluation1

IMS Key Treatment Recommendations
1. Start treatment early, before irrevocable atrophic changes
have occurred
2. Continued treatment is needed to maintain the benefits
1. All local estrogen preparations are effective
2. Patient preference will usually determine the treatment
that is used

IMS Key Treatment Recommendations
5. Additional progestin is not indicated when appropriate
low-dose, local estrogen is used, although long-term data
(more than 1 year) are lacking
6. If estrogen is ineffective or undesired, vaginal lubricants
and moisturizers can relieve symptoms due to dryness
7. It is essential that healthcare providers routinely engage
in open and sensitive discussions with post-menopausal
women about their urogenital health to ensure that
symptomatic atrophy is detected early and managed
appropriately

Summary: Key Learning Points
 Vaginal atrophy is a common, chronic condition that can have a
significant effect on a woman’s quality of life
 Women suffer in silence, are reluctant to initiate a dialogue about their
symptoms, and are unaware that effective treatments are available
 There is a need to normalize this condition
 Treatment with local estrogen is simple and safe and can transform a
woman’s quality of life including intimate relationships
 43% of Canadian women are open to treatment with local estrogen
therapy that maintains normal hormone levels
 Physicians need to routinely discuss and effectively manage the
symptoms of vaginal atrophy in post-menopausal women

Post-Test Questions
1. In vaginal atrophy:
A. Vaginal pH decreases
B. Blood flow is maintained
C. Parabasal cells predominate in the epithelium
D. Inflammation is always absent

Post-Test Questions
2. Post-menopausal Canadian women:
A. Have a good understanding of vaginal atrophy and its
associated symptoms
B. Are aware of the chronic nature of the condition
C. Are likely to use over-the-counter products before
discussing symptoms with their physicians.
D. More than 40% would be willing to use local vaginal
estrogen to treat vaginal atrophy symptoms
E. All of the above
F. C and D

Post-Test Questions
3. Local estrogen therapy:
A. Effectively manages symptoms
B. Reverses atrophic changes
C. Has a positive impact on intimate relationships
D. All of the above
E. A and B

Post-Test Questions
4. How comfortable are you discussing
treatment options for vaginal atrophy with
A. Very uncomfortable
B. Somewhat uncomfortable
C. Somewhat comfortable
D. Very comfortable

Empowering the vaginal atrophy dialogue multi_therapeutic2

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