3. 1 Int J Women’s Health. 2011;3: 207–21; 2. J Midlife Health. 2013;4(1):8–15; 3. Open Access J
Contracep. 2013; 4:21–28; 4 NICE 2007; 5. Drug safety 2004
Major impact on a woman’s quality of life
5. LNG-IUS first designed in Finland – 1990
• From the concept of contraception, the
spectrum of indications broadened
• In sept 2009 , the US FDA approved
mirena as a treatment for heavy
menstrual bleeding
Obstet gynecol 2009;1104-1116
6. NatIoNaL eSSeNtIaL LISt
of medIcINe (NeLm) 2011
Out of 348 drugs Govt. of India has
included LNG-IUS as hormonal IUD
in NELM 2011
Source: Union Health Ministry of India
From Research to Practice – Long Way to Go
7. • Progestin releasing
intrauterine system
• T shaped polyethylene
frame
• Contains 52 mg
levonorgestrel
• Releases 20 µg LNG daily
What is Mirena - LNG IUS
8. Mirena :‘Local is logical’
local mode of action
• Prevents endometrial
proliferation
• Thickens cervical mucus
• Inhibits sperm motility
serum levels are 4 times lower than
after oral ingestion
11. Motivational Facts …….
• Over 60% of women diagnosed with
HMB ended up having a hysterectomy
within 5 years from the diagnosis
• About 1/3 rd of hysterectomies for HMB
result in removal of anatomically
normal uterus
17. Efficacy of LNG - IUSEfficacy of LNG - IUS
“The results are in line with NICE
recommendations 2007, as they show
that women should be offered Mirena
first to avoid more invasive treatment”
19. 97% Reduction in Menstrual Blood Loss
over 1 year of therapy
Significant increase in Hemoglobin and Serum Ferritin
level
20. Comparison of Rx Modalities
Progesterone or LNG IUS
LNG IUS reduces menstrual blood loss more
effectively and has a higher likelihood of
treatment success than oral medroxyprogesterone
acetate.
Obstet Gynecol. 2010
21. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing
Intrauterine System in Primary Care against Standard Treatment for
Menorrhagia (ECLIPSE) Trial
21
Improvements in MMAS scores were significantly greater
(lesser score= more severity)
Gupta J, Kai J, Middleton L, Pattison H, Gray R, Daniels J for the ECLIPSE Trial Collaborative Group N Engl J Med 2013;368:128-37
Daily routine work, social and family life, and psychological and physical well-being
Menorrhagia Multi-Attribute Scale (MMAS)
22. COCs= Combined OC pills; LNG-IUS – Levonorgestrel Intrauterine System; GnRH – Gonadotrophin Releasing
Hormone agonists
Finnish Survey:: Among 75 Obstericians/ gynaecologists
working at the Helsinki University Central Hospital (2013)
Pre congress course on heavy menstrual bleeding, 10‐ th
Congress of European Society of Gynecologists, Brussels Belgium September 18-21 2013
In your opinion what is the most effective medical treatment for HMB?
23. Finnish trial
(multicentric RCT 236 pts)
• Mirena improves the quality of life as
effectively as surgical treatment at 1 year.
• Women ranked their satisfaction with a mean
score of 7 / 10.
• Less than 5% of women required
subsequent operative treatment
• Mirena is more cost effective than
hysterectomy in the short term
24. LNG IUS versus Hysterectomy
24
When patients were given the option of mirena
a significant percentage of women cancelled
their hysterectomy
Pekka Lähteenmäki et al. 1998 316: 1122 (6)
25. Objective: To evaluate the efficacy, acceptability,
and possible side effects of a
levonorgestrelreleasing
intrauterine system for menorrhagia.
Method : Sixty-three women with menorrhagia
but without uterine enlargement, endometrial
hyperplasia, or endometrial carcinoma
were enrolled in this prospective, open,
nonrandomized clinical trial and LNG-IUS was
inserter in post menstrual period to these women
Result : Menstrual pattern, number of bleeding
days, and subjective and objective
estimation of menstrual blood loss using a
pictorial blood loss assessment chart (PBAC)
were recorded before insertion and at specific
intervals for 4 years.
Conclusion: Using the LNG-IUS is an effective
and well-accepted option overall for the medical
management of menorrhagia.
Mirena is an effective and well-accepted option for the medical
management of menorrhagia in India : An AIIMS Study 2007
26. • OBJECTIVE : To evaluate the efficacy of an
intrauterine system releasing levonorgestrel (LNG-IUS,
Mirena) in the treatment of women with menorrhegia .
• METHOD(S) : This was a prospective, non-
comparative study. Twenty patients who had
Menorrhagia due to non-malignant causes were
included in the study (age range 20-42 years). However
patients of fibroid uterus with uterine size more than 12
weeks and those with submucous fibroid were
excluded. A LNG-releasing-intrauterine system was
inserted on any day during bleeding or within a week of
cessation of bleeding. Menstrual blood loss was
assessed, before LNG-IUS was inserted, and after 3, 6,
and 12 months of use.
• RESULTS : The most common bleeding pattern at 3
months after insertion was spotting and after 6 and 12
months the majority of women presented with
amenorrhea or oligomenorrhea. One woman requested
removal of the LNG-IUS because of continuous
spotting even after 4 months of insertion. The
remaining women continued the use of LNG-IUS
beyond 1 year.
• CONCLUSION: LNG-IUS is an effective treatment for
Menorrhagia due to benign causes and could be an
alternative to hysterectomy.
Mirena is an effective treatment for Menorrhagia and
could be an alternative to hysterectomy: An Indian Study
2005
27. Bleeding pattern in the first 5-year period
Rönnerdag M, Odlind V. Acta Obstet Gynecol Scand 1999;78:716–21
Infrequent
3.7% Regular
70.3%
Ammenorhea
26%
32. COUNSELLING
Is it not very costly as
compared to oral
medication?
Doctor, I am spotting
daily? What do I do?
I have not had periods
since 6 months? Am I
in menopause?
34. Irregular Bleeding or spotting
May last for 3 - 4 months
COC
Progesterone
GnRHa are used to tide over this period
Sevista
Acceptance depends on good
pre insertion counselling
40. Endometrial Hyperplasia
• Beneficial effects are observed by1
year.
• Treatment should be reliably
monitored through regular 6-montly
outpatient follow up
Eur J Obstet Gynecol Reprod Biol. 2008
41. Early-stage Endometrial Carcinoma
May have a role in selected patients
willing to preserve fertility
• Endometrial protection for women on tamoxifen
• Women With Clotting Disorders Or Under Anti
Thrombotic Treatment
Conservative treatment of early endometrial cancer: preliminary
results of a pilot study.
Gynecol Oncol. 2011; 120(1):43-6
42. How long ?
NICE GUIDELINES : If inserted > 45 yrs of
age and has complete amenorrhea may
continue to use it until menopause.
It can be removed at mid 50s as long as it controls the
bleeding
HRT
Change it after 4 years “licenced”
Contraception
< 45years…..5 years
> 45 years ….7 years
43. Are there any drugs that interact
with mirena ?
• Women using mirena
may be reassured that
• No drugs are known
to interact with
mirena
• Can be used safely
with ATT
• No effect on BMD
Not to be used as Emergency Contraceptive
44. Health Benefits
No significant change in
• Blood pressure
• Lipid profile
• Coagulation factors
• Carbohydrate metabolism
• Liver function
• Bone mineral density
47. Used in 300 cases
INCLUDING FIBROIDS AND ENDOMETRIOSIS
(July 2014)
Expulsion in 3
(UBT , hysterectomy , reinsertion )
• It can replace the need of hysterectomy in
50 % of cases.
• Especially useful when future fertility is
desired
52. LNG - IUS
Its not simply a
Pregnancy
Hormone.
But in true sense,a
Mother
Hormone.
53. ADDRESS
11 Gagan Vihar, Near Karkari
Morh Flyover, Delhi - 51
CONTACT US
9650588339, 011-22414049,
WEBSITE :
www.lifecarecentre.in
www.drshardajain.com
www.lifecareivf.com
E-MAIL ID
Sharda.lifecare@gmail.com
Lifecarecentre21@gmail.com
info@lifecareivf.com
&
Thank You
Editor's Notes
Ghazizadeh S. A randomized clinical trial to compare levonorgestrel-releasing intrauterine system (Mirena) vs. transcervical endometrial resection for treatment of menorrhagia. Int J Women’s Health. 2011;3: 207–21
Magon N, Chauhan M, Goel P, et al . Levonorgestrel intrauterine system: Current role in management of heavy menstrual bleeding. J Midlife Health. 2013;4(1):8–15.
Bitzer J. Women’s attitudes towards heavy menstrual bleeding, and their impact on quality of life. Open Access J Contracep. 2013; 4:21–28
National Collaborating Centre for Women’s and Children’s Health. Heavy Menstrual Bleeding Clinical Guideline. London: RCOG Press for NICE; 2007.
Roy SN, Bhattacharya S. Benefits and risks of Pharmacological Agents used for treatment of menorrhagia. Drug Safety 2004; 27(2): 75-90
In the past, over 60% of women diagnosed with HMB ended up having a hysterectomy within 5 years from the diagnosis, with 80% having an anatomically normal uterus removed
National Collaborating Centre for Women’s and Children’s Health Clinical Guideline on Heavy Menstrual Bleeding. January 2007 available at : http://www.nice.org.uk/CG44 accessed 4 Dec 2008
