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Effects of vaginal estradiol tablets and

moisturizer on menopause-specific quality of


life and mood in healthy postmenopausal
women with vaginal symptoms: a randomized
clinical trial

By : Gabriella Patricia Angkow (01073170090)


Preceptor : dr Julita Nainggolan Sp.OG
Introduction

▪ vulvovaginal symptoms : Moderate to severe vulvovaginal


lack of lubrication and symptoms in postmenopausal
discomfort or pain with women are associated with
vaginal intercourse significant decreases in sexual
functioning and in quality of life
(QOL)

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vaginal estrogen creams, vaginal
estrogen tablets, intravaginal
Randomized, prasterone
Double Blind, (dehydroepiandrosterone), and
Placebo-controlled ospemifene reduce vulvovaginal
symptoms

Vaginal menopause-related
Vaginal
estradiol QOL, depressive
moisturizer Dual
tablet +
+ placebo placebo symptoms, and
placebo
tablet anxiety
gel 3
Treatment Data
Study Design and study collections
procedures

Outcomes/ Other Statistical


Measurement measurements analysis

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Study Design

▪ randomized, double-blind, placebo-


controlled 12-week trial
▪ 302 women from April 2016 to February 2017

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Inclusion Criteria :
• 45 to70 years old Exclusion Criteria :
• 2 or more years since last • current vaginal infection
menses, reported 1 or • use of hormonal
more moderate–severe medication in past 2 months
symptom of vulvovaginal • use of antibiotics, vaginal
itching, moisturizer, probiotic,
pain, dryness, or irritation prebiotic, or douche in past
experienced at least weekly month
within • chronic premenopausal
the past 30 days vulvovaginal symptoms
• pain with penetration at
least once monthly

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Treatments and Study Procedures

Targeted Woman : 50-70 years old

vaginal estradiol 10 mcg placebo vaginal tablet + placebo tablet + placebo


tablet (Vagifem) + vaginal moisturizer gel
placebo vaginal gel (Replens)
(hydroxyethyl cellulose)

Vaginal tablet (active or placebo) Vaginal gel (active or placebo)

Daily for 2 weeks, then twice weekly for Every 3 days throghout the trial
remaining 10 weeks
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“ Follow up at 4 and 12 weeks
postrandomization

Completion of
questionnaires

Menopause-specific QOL, mood


and sexual function 8
Outcomes/Measurements

Menopause Evaluated Anxiety


QOL Mood

Menopause-
Specific Quality Generalized Patient Health
of Life Anxiety Disorder Questionnaire
(MENQOL) (GAD-7) (PHQ-8)
questionnaire

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Other Measurements

▪ Primary outcome of ▪ At each visit, women


the trial was severity of completed a
the most bothersome questionnaire about
symptom presence and severity
of vulvovaginal
symptoms

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Statistical Analysis

▪ A modified intent-to-treat analysis included all


randomized participants who provided follow-
up QOL, depressive symptoms, or anxiety
symptoms data at week 4, week 12, or both,

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Results
receive vaginal estradiol tablet
plus placebo gel (n=102),
302 women placebo tablet plus vaginal
moisturizer (n=100), or dual
placebo (n=100)

61 years; 88% were


Mean age of study white and 85% were
participants married or partnered

Most bothersome Pain with vaginal


penetration
symptom

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Mean (SD)
total 3.3 (SD 3.1)
MENQOL

70 women (23.3%) 28 (9.3%) had


indicating mild
PHQ 8 scores indicating
Scores
depressive moderate anxiety
symptoms

70 (23.3%) 28 (9.3%) had


GAD-7
indicating mild Scores scores indicating
anxiety moderate anxiety

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4
Effect of treatment assignment on total
MENQOL scale and domain subscales

▪ Vaginal estradiol ▪ Greater improvement


+ placebo gel in MENQOL
▪ Vaginal estradiol ▪ Sexual function domain
▪ Vaginal ▪ Not result in greater
moisturizer + improvement in
placebo tablet MENQOL

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Effect of treatment assignment on depressive
symptoms and anxiety

PHQ-8
No
Statistically
Significant
GAD-7

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Discussion
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▪ Here you have a list of items
▪ And some text
▪ But remember not to overload your slides
with content

Your audience will listen to you or read the


content, but won’t do both.
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YOU CAN ALSO SPLIT YOUR CONTENT

White Black
Is the color of milk and Is the color of coal, ebony,
fresh snow, the color and of outer space. It is the
produced by the darkest color, the result of
combination of all the the absence of or
colors of the visible complete absorption of
spectrum. light.

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IN TWO OR THREE COLUMNS

Yellow Blue Red


Is the color of gold, Is the colour of the Is the color of blood,
butter and ripe clear sky and the and because of this it
lemons. In the deep sea. It is has historically been
spectrum of visible located between associated with
light, yellow is found violet and green on sacrifice, danger and
between green and the optical spectrum. courage.
orange.

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Strengths of this trial :
Use of reliable and valid measures of
Strength of This Trial
menopause-related QOL and mood
symptoms
Use of placebos for both the vaginal
estradiol and the vaginal moisturizer
Excellent participant retention and
medication adherence.

26
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Want big impact?
Use big image.

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USE DIAGRAMS TO EXPLAIN YOUR IDEAS

Vestibulum congue Vestibulum congue Vestibulum congue tempus


tempus tempus
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sed do eiusmod tempor. sed do eiusmod tempor. dolor sit amet elit, sed do eiusmod tempor.

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AND TABLES TO COMPARE DATA

A B C

Yellow 10 20 7

Blue 30 15 10

Orange 5 24 16

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LET’S REVIEW SOME CONCEPTS

Yellow Blue Red


Is the color of gold, butter and Is the colour of the clear sky and Is the color of blood, and
ripe lemons. In the spectrum of the deep sea. It is located because of this it has
visible light, yellow is found between violet and green on the historically been associated
between green and orange. optical spectrum. with sacrifice, danger and
courage.

Yellow Blue Red


Is the color of gold, butter and Is the colour of the clear sky and Is the color of blood, and
ripe lemons. In the spectrum of the deep sea. It is located because of this it has
visible light, yellow is found between violet and green on the historically been associated
between green and orange. optical spectrum. with sacrifice, danger and
courage.
34
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THANKS!
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You can find me at:
▪ @username
▪ user@mail.me

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CREDITS

Special thanks to all the people who made and


released these awesome resources for free:
▪ Presentation template by SlidesCarnival
▪ Photographs by Unsplash

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