ENDOMETRIOSIS
AN OVERVIEW
PREVALENCE
Endometriosis affects 1 in 10 women of
reproductive age worldwide
20-40% of infertile women & 5% of fertile women
Also found in 6-43% of women undergoing
laparoscopic sterilization
52% of teenagers
http://www.asrm.org/Endometriosis_booklet/
TIMELINE OF GUIDELINES
FOR ENDOMETRIOSIS
1927 1985 2005 2006 2006 2010
John ASRM Staging of ESHRE ASRM RCOG SOGC
Alberst Endometriosis Clinical Clinical Clinical Clinical
on guidelines guidelines guidelines guidelines
Sampso
n
Which treatment? Surgical Medical
SOGC: Society of Obstetricians and Gynaecologists of
WHEN IS THE MEDICAL
TREATMENT REQUIRED
First line treatment
After surgery to reduce recurrence
When surgery is not possible or refused
“Endometriosis should be viewed as a chronic disease
that requires a life-long management plan with the goal
of maximizing the use of medical treatment and avoiding
repeated surgical procedures”
actice committee of the ASRM. Fertility Sterility 2008;90:S260-S269
MEDICAL TREATMENTS
Combined oral contraceptives First line
Oral progestins: Dienogest
To induce hypo-estrogenism or antagonize estrogen
action.
Danazol
Second line
GnRH agonists
PROGESTINS AND
ENDOMETRIOSIS
Their effectiveness is due to their proven anti-
inflammatory effect;
Ideal for long-term treatment
Effective, inexpensive and generally well tolerated.
Side effects: anovulation and hypoestrogenism,
Bleeding abnormalities, bloating and weight gain
Int J Gynaecol Obstet 2010;108:21-25
DIENOGEST
INNOVATION IN
ENDOMETRIOSIS
DIENOGEST : INNOVATION IN
ENDOMETRIOSIS
At the 11th World Congress on Endometriosis
(WCE), held in Montpellier, France,
Dienogest was presented as the
new promising therapy
specifically developed to treat endometriosis
Reference: 11th World Congress on Endometriosis (WCE), held in Montpellier, France,
Dienogest is
presented
in FIGO, 2012
as a
First Line therapy for
Endometriosis
FIGO: International Federation of Gynecology and Obstetrics
Recently Presented in ….
Dienogest is an excellent drug
for the treatment of deeply
endometriosis
DOSE-RANGE STUDY: DESIGN
Open, randomized,
comparative, multicenter
Women with histologically-
confirmed endometriosis
(stage I, II, or III according to
rFAS
Dienogest (1, 2, or 4 mg- all
one tablet/day
24 weeks
Efficacy outcomes:
Lesion score (rFAS) at
baseline and 24 weeks
Improvement of symptoms
Int J Gynaecol Obstet 2010;108:21-25
DOSE-RANGE STUDY: DESIGN
First Second
laparoscopy for laparoscopy for
diagnosis/rFAS rFAS score after
score at week 0 DNG 1 mg/day 24 weeks of
n=4 treatment
DNG 2 mg/day
R n=29
DNG 4 mg/day
Week 0 n=35 Week 24
Inclusion criteria
Women from menarche to menopause
Endometriosis stages I to III (rFAS) confirmed by laparoscopy and
biopsy *1mg group stopped due to insufficient bleeding contro
R=randomization
Int J Gynaecol Obstet 2010;108:21-25
Dose-range study: Severity by rFAS Score
American Fertility Society scores
Baseline
At 24 wks Dienogest 2 mg
*P<0.001
-75%
-87%
*
*
Stage I Stage II Stage III
Int J Gynaecol Obstet 2010 Jan;108(1):21-5
Proportions of women (%) reporting
endometriosis-related symptoms
Both 2mg and 4 mg
regimens shown
similar improvement
Int J Gynaecol Obstet 2010;108:21-25
LONG -TERM EXTENSION
STUDY
Arch Gynecol Obstet. 2011
LONG -TERM EXTENSION STUDY:
PELVIC PAIN (VAS SCORE)
Efficacy shown over 15 months
Arch Gynecol Obstet. 2011
LONG -TERM EXTENSION STUDY:
FREQUENCY OF MAX INTENSITY BLEEDING
Arch Gynecol Obstet. 2011
DIENOGEST VERSUS LEUPROLIDE
ACETATE
STUDY DESIGN
Randomized, open label,
active controlled, multicenter
Dienogest 2mg/day or
Leuprolide acetate 3.75mg IM
every 4 weeks
24 weeks
VAS score for endometriosis-
associated pelvic pain every 4
weeks
Hum Reprod. 2010;25(3):633–
DIENOGEST VERSUS LEUPROLIDE
ACETATE:
OVERALL REDUCTION OF PELVIC PAIN
MEAN REDUCTION OF PELVIC PAIN
Non inferior versus LA
(P<0.0001)
Hum Reprod. 2010;25(3):633–
DIENOGEST VERSUS LEUPROLIDE
ACETATE:
OVERALL INCIDENCES OF HOT FLUSHES
MEAN INCIDENCES OF HOT FLUSHES
Number of hot flushes/week
Leuprolide Dienogest
Hum Reprod. 2010;25(3):633–
DIENOGEST VERSUS LEUPROLIDE
ACETATE:
EFFECT ON BMD
Hum Reprod. 2010;25(3):633–
DIENOGEST VERSUS LEUPROLIDE
ACETATE
CONCLUSION
Dienogest 2 mg/day orally demonstrated
equivalent efficacy to depot LA at standard
dose in relieving the pain associated
with endometriosis, although offering
advantages in safety and tolerability.
Hum Reprod. 2010;25(3):633–
Dienogest in Ovarian chocolate cysts &
Adenomyosis
100%
reduction
in Pain
Presented in FIGO,
2012
Phase III study
Effect of Dienogest on size of chocolate cysts
83%
reduction in
Ovarian
Chocolate
Cyst with
Dienogest
ADENOMYOSIS
DIENOGEST IN POST
OPERATIVE TREATMENT
DIENOGEST COMPLIANCE
Treatment compliance during the long-term
study was high as 98%
Discontinuation rates due to adverse events or
lack of efficacy were both low (2.4% and 0.6%,
respectively)
Patient satisfaction with dienogest: 88.9% of
women responding that they were “certainly
willing” or “would prefer” to use dienogest
again
Int J Womens Health. 2011; 3: 175–
INDICATIONS & DOSAGE
Indications:
Treatment of Endometriosis
Extragenital endometriosis (bladder,
colon)
Pre & post operative treatment for
endometriosis
Adenomyosis
Dosage:
2mg Once daily
