empowering the vaginal atrophy dialogue multi_therapeutic2

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Empowering the Vaginal Atrophy Dialogue

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Page 1: Empowering the vaginal atrophy dialogue multi_therapeutic2

Empowering the Vaginal Atrophy Dialogue

Page 2: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 3: Empowering the vaginal atrophy dialogue multi_therapeutic2

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)

Page 4: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 5: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 6: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 7: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 8: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 9: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 10: Empowering the vaginal atrophy dialogue multi_therapeutic2

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.

Page 11: Empowering the vaginal atrophy dialogue multi_therapeutic2

IMS Recommendations: Background

Post-menopausal vaginal atrophy:A common cause of distressing symptoms due to estrogen deficiencyPoorly recognized by healthcare professionalsShould 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.

Page 12: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Page 13: Empowering the vaginal atrophy dialogue multi_therapeutic2

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 activityThe vagina narrows and shortens

Page 14: Empowering the vaginal atrophy dialogue multi_therapeutic2

Vaginal Atrophy Pathophysiology:Cellular Changes

Thick, healthy, well-estrogenized

lining of the vagina in premenopausal women

Thin, dry lining of vaginadue 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

Page 15: Empowering the vaginal atrophy dialogue multi_therapeutic2

Discussion Question

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

Page 16: Empowering the vaginal atrophy dialogue multi_therapeutic2

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]

Page 17: Empowering the vaginal atrophy dialogue multi_therapeutic2

VIVA Survey Results: How Many Women Experience Symptoms of Vaginal Atrophy?

VIVA, Vaginal Health: Insights, Views & Attitudes.Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

50% of Canadian women experienced vaginal symptoms

59% rated these symptoms as moderate or severe

Page 18: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 19: Empowering the vaginal atrophy dialogue multi_therapeutic2

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;13:509-22.2. Nappi RE, Kokot-Kierepa M. Climacteric. 2012;15:36-44.

Page 20: Empowering the vaginal atrophy dialogue multi_therapeutic2

VIVA Survey Results: Which Symptoms of Vaginal Atrophy Do Canadian Women Experience?

VIVA, Vaginal Health: Insights, Views & Attitudes.Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

Dryness was by far the most commonly experienced symptom of vaginal atrophy

Page 21: Empowering the vaginal atrophy dialogue multi_therapeutic2

In Her Own Words… About Her Symptoms

Play videoJoan 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.”

Page 22: Empowering the vaginal atrophy dialogue multi_therapeutic2

Discussion Question

How does vaginal atrophy impact the lives of post-menopausal women?

Page 23: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

IMS, International Menopause Society. VIVA, Vaginal Health: Insights, Views & Attitudes.1. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.2. Nappi RE, Kokot-Kierepa M. Climacteric. 2012;15:36-44.3. 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

Page 24: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

Page 25: Empowering the vaginal atrophy dialogue multi_therapeutic2

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 themselvesas 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.

Page 26: Empowering the vaginal atrophy dialogue multi_therapeutic2

58%

49%

35%

23%

62%61%

28%

14%

22%

76%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Less sex Less satisfyingsex

Put off havingsex

Stoppedhaving sexaltogether

Avoidedintimacy

Resp

onde

nts,

%

Women

Men

CLOSER, CLarifying Vaginal Atrophy’s Impact On SEx and Relationships.Gingras L, et al. SOGC 68th Annual Conference. June 2012. Poster 486.

CLOSER Survey: Effects of Vaginal Discomfort on Intimate Relationships (Canadian Data)

Page 27: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

VIVA, Vaginal Health: Insights, Views & Attitudes.Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

Page 28: Empowering the vaginal atrophy dialogue multi_therapeutic2

Discussion Question

How would you start the vaginal atrophy conversation?

Page 29: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

IMS, International Menopause Society.1. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.2. Gingras L, et al. SOGC 68th Annual Conference. June 2012. Poster 486.

Page 30: Empowering the vaginal atrophy dialogue multi_therapeutic2

IMS Recommendations: 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?”

IMS, International Menopause Society.Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Page 31: Empowering the vaginal atrophy dialogue multi_therapeutic2

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.Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

Page 32: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

IMS, International Menopause Society. VIVA, Vaginal Health: Insights, Views & Attitudes.1. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.2. Nappi RE, Kokot-Kierepa M. Climacteric. 2012;15:36-44.3. Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

Page 33: Empowering the vaginal atrophy dialogue multi_therapeutic2

VIVA Survey Results: Canadian Women Willingto 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

VIVA, Vaginal Health: Insights, Views & Attitudes.Frank SM, et al. Menopause Int. 2012 Nov 30. [Epub ahead of print]

Page 34: Empowering the vaginal atrophy dialogue multi_therapeutic2

Discussion Questions

What are the available treatment options for vaginal atrophy?

Page 35: Empowering the vaginal atrophy dialogue multi_therapeutic2

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-S30.2. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.3. Bélisle S, et al; Menopause Guidelines Committee. J Obstet Gynaecol Can. 2006;28(2 Suppl 1):S7-S94.

Page 36: Empowering the vaginal atrophy dialogue multi_therapeutic2

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.1. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.2. 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.

Page 37: Empowering the vaginal atrophy dialogue multi_therapeutic2

IMS Recommendations:Local Estrogen Therapy

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

IMS, International Menopause Society.Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Vaginal cream with applicator Intravaginal ring

Vaginal tablet with applicator

Page 38: Empowering the vaginal atrophy dialogue multi_therapeutic2

SOGC Recommendations: Local Estrogen Therapy

SOGC Clinical Practice GuidelinesConjugated 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.

Page 39: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 40: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 41: Empowering the vaginal atrophy dialogue multi_therapeutic2

Local Estrogen Therapy: 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

Page 42: Empowering the vaginal atrophy dialogue multi_therapeutic2

Local Estrogen Therapy: Effect on Vaginal Health

Grading vaginal healthEvaluations 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

Simon J, et al. Obstet Gynecol. 2008;112(5):1053-60.

Page 43: Empowering the vaginal atrophy dialogue multi_therapeutic2

Local Estrogen Therapy: Effect on Vaginal Health

P-values describe comparisons of the change from baseline between treatment groups.

LOCF, Last observation carried forward.Simon J, et al. Obstet Gynecol. 2008;112(5):1053-60.

Improvement in vaginal health

p<0.001

p<0.001p<0.001 p<0.001

p<0.001

Page 44: Empowering the vaginal atrophy dialogue multi_therapeutic2

Local Estrogen Therapy: Effect on Bothersome Symptoms

p=0.053

p=0.014 p=0.003 p=0.004

P-values describe comparisons of the change from baseline between treatment groups.

LOCF, Last observation carried forward.Simon J, et al. Obstet Gynecol. 2008;112(5):1053-60.

Change in most bothersome symptom score

Page 45: Empowering the vaginal atrophy dialogue multi_therapeutic2

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%)

CLOSER, CLarifying Vaginal Atrophy’s Impact On SEx and Relationships.Gingras L, et al. SOGC 68th Annual Conference. June 2012. Poster 486.

Page 46: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

CLOSER, CLarifying Vaginal Atrophy’s Impact On SEx and Relationships.Gingras L, et al. SOGC 68th Annual Conference. June 2012. Poster 486.

Page 47: Empowering the vaginal atrophy dialogue multi_therapeutic2

In Her Own Words… About Her Treatment

Play VideoJoan 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.”

Page 48: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 49: Empowering the vaginal atrophy dialogue multi_therapeutic2

Local Estrogen Therapy: Contraindications

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

Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Page 50: Empowering the vaginal atrophy dialogue multi_therapeutic2

Local Estrogen Therapy: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

Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Page 51: Empowering the vaginal atrophy dialogue multi_therapeutic2

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. 1. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.2. The North American Menopause Society. Menopause. 2007;14:357-69.

Page 52: Empowering the vaginal atrophy dialogue multi_therapeutic2

Local Estrogen Therapy: 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 mannerAppropriate 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-S30.2. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Page 53: Empowering the vaginal atrophy dialogue multi_therapeutic2

Local Estrogen Therapy: 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

VIVA, Vaginal Health: Insights, Views & Attitudes.1. Sturdee DW, Panay N. Climacteric. 2010;13:509-22.2. Nappi RE, Kokot-Kierepa M. Climacteric. 2012;15:36-44.

Page 54: Empowering the vaginal atrophy dialogue multi_therapeutic2

IMS Key Treatment Recommendations

1. Start treatment early, before irrevocable atrophic changes have occurred

2. Continued treatment is needed to maintain the benefits

3. All local estrogen preparations are effective

4. Patient preference will usually determine the treatment that is used

IMS, International Menopause Society.Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Page 55: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

IMS, International Menopause Society.Sturdee DW, Panay N. Climacteric. 2010;13:509-22.

Page 56: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 57: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 58: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 59: Empowering the vaginal atrophy dialogue multi_therapeutic2

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

Page 60: Empowering the vaginal atrophy dialogue multi_therapeutic2

Post-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