1. Dr. Sharda Jain
Dr. Jyoti Agarwal
Dr. Jyoti Bhaskar

2. 2014
INTERACTIVE SESSION
FEEDBACK
SHARE EXPERIENCE

3. CDR INSTITUTE OF LUCKNOW -- 1991

4. SERM
A NON STEROIDAL
MEDICAL TREATMENT
FOR
DUB

5. “An optimally designed SERM with Varied Tissue Response”

7.  PILOT STUDY AT AIIMS IN 2009
 A DOUBLE BLINDED RCT IN BELGAUM IN
2011
 OTHER SMALLER STUDIES

8. LIARE TEAM
OVER 700 PATIENTS TREATED WITH ORMELOXIFENE

9. PERSISTENT ,
NON RESPONDING
 ANTIFIBRINOLYTICS, PROGESTERONES
 NO ESTROGENS TILL AGE OF 16 YRS
 ORMELOXIFENE : HB >12 gm %

10. VERY DISTRESSING
TVS – NORMAL
 DAFLON FOR 1 WEEK
 ORMELOXIFENE – DOUBLE BENEFIT

11.  INJ DMPA IS GIVEN INITIALLY
 THEN ORMELOXIFENE -- PROVIDES
CONTRACEPTION AND CONTROL OF BLEEDING

12.  FIRST 3 - 6 MONTHS – THE DIFFICULT PERIOD
 EXTREMELY GOOD RESPONSE

13.  TVS IN ALL PATIENTS
 ENDOMETRIAL BIOPSY
TO RULE OUT HYPERPLASIA

14.  Convenient dosage – twice or once weekly
 60 mg tablets twice a week ( for example, Sunday &
Wednesday) for 12 weeks followed by one tablet of 60
mg once a week for another 12 weeks

15. 1. Postmenopausal Bleeding
2. Endometrial Hyperplasia
3. Infertile patients
4. PCOS
Special mention:
1. In PMB , after balloon therapy – once a week
for 3 months
2. In hyperplasia – along with progesterone's

16.  Ovarian Cysts

17. 15 CASES -- ON BIOPSY , ATROPHIC ENDOMETRITIS

19. Progestational agents
 Medroxyprogesterone acetate,
 Norethisterone
 Depo-medroxyprogesterone
 Oral contraceptives
 Levonorgestrel-releasing intrauterine device
 Clomiphene citrate
Other – Antiprostaglandins, antifibrinolytics, danazol,
gonadotropin-releasing hormone analogs (GnRH).
DUB – Medical Management Options –DUB – Medical Management Options –

20. 0 -25 -50 -75 -100
Mirena
Placebo
Prostaglandins Synthetase Inhibitor
T A
COCs
Decrease %
Percentage reduction in blood loss

21. QUEST GOES ON ………

22.  Medical Management remains the first line
 Option has to be individualised
 No medication so far is satisfactory
 Let us be selective, develop our own
wealth of experience and share

23. FEEDBACK !!!!

24. Dr.Jyoti Bhaskar
MD MRCOG
Director Lifecare IVF
Consultant
Lifecare Centre, Pushpanjali Crosslay Hospital

25. “Excessive menstrual blood loss which
interferes with the woman’s physical,
emotional, social and material quality of life,
and which can occur alone or in combination
with other symptoms.”
Nice guidelines 2007

26. Woman Centred Care
 Goals
 Control bleeding
 Correct anemia/associated conditions
 Prevent recurrence
 Improve quality of life

27. MEDICAL RX
MINIMAL ACCESS
SURGERY
HYSTERECTOMY
Any interventions should aim to improve quality of life measures. [D] -- NICE guidelines

28.  Whether cycles are ovulatory
or not
 Age
 Whether the patient requires
contraception
 Desires Fertility
 Choice of the patient

29. First Line Levonorgestrel-releasing intrauterine
system (LNG-IUS)
Second Line Tranexamic acid (non-hormonal)
Can be used in parallel with investigations. If
no improvement, stop treatment after 3 cycles
Non-steroidal anti-inflammatory drugs (NSAIDs)
If no improvement, stop treatment after 3 cycles.
Can be used in parallel with investigations
Preferred over tranexamic acid in dysmenorrhoea
Combined oral contraceptives
Pharmaceutical Treatment – Nice Guidelines

30. Third Line Oral progestogen
Norethisterone (15 mg) daily from days 5 to
26 of the menstrual cycle
Injected progestogen
Others Gonadotrophin-releasing hormone
analogue (Gn-RH analogue)
If used for more than 6 months add back
HRT therapy is recommended

31.  Oral progestogens in the luteal phase only
 Danazol
 Ethamsylate
 Dilatation and curettage (D and C)

32.  Medical treatment is an effective first line
therapeutic option for abnormal uterine
bleeding.
 Tailored to the individual woman’s
therapeutic goals, desire for contraception,
underlying medical conditions, and tolerance
of side effects

33.  Cyclic or Predictable in timing
Non-hormonal options such as non-
steroidal anti-inflammatory drugs and
antifibrinolytics
 Who desire effective contraception.
COC, INJ DMPA, LNG-IUS

34.  Cyclic luteal-phase progestins do not
effectively reduce blood loss and therefore
should not be used as a specific
treatment for heavy menstrual bleeding
 Medical or Surgical treatments have failed
or are contraindicated :
Danazol and gonadotropin-releasing
hormone agonists

35. Progestational agents
 Medroxyprogesterone acetate,
 Norethisterone
 Depo-medroxyprogesterone
 Oral contraceptives
 Levonorgestrel-releasing intrauterine device
 Clomiphene citrate
Other – Antiprostaglandins, antifibrinolytics, danazol,
gonadotropin-releasing hormone analogs (GnRH)
.
DUB – Medical Management Options –DUB – Medical Management Options –

36. 0 -25 -50 -75 -100
Mirena
Placebo
Prostaglandins Synthetase Inhibitor
T A
COCs
Decrease %
Percentage reduction in blood loss

37. QUEST GOES ON ………

38. “The ideal therapy should be a
designer drug which can block
the action of estrogen on the
endometrium but not its beneficial
actions on other tissues”

39. J Clin Oncol 2000 18:3172-3186.
Estrogens
Antiestrogens
SERMs
TamoxifineTamoxifine
DroloxifineDroloxifine
ToremifineToremifine
RaloxifineRaloxifine
OrmeloxifineOrmeloxifine

40. “An optimally designed SERM with Varied Tissue Response”

41.  It blocks the cytosol receptors by its competitive binding affinity over
Estradiol
 It’s action lasts long after the drug is withdrawn
 The long elimination of the half-life of ormeloxifene provides a basis for a
weekly dosing schedule1
 It is estrogen antagonist in Uterus & Breast and has mild estrogenic action on
vagina, Bone mineral density, CNS and Serum Lipids2
 No action on Hypothalamic Pituitary Ovarian function, Thyroid or Adrenal
 No Progestational, Androgenic or Antiandrogenic properties2

42.  Dysfunctional uterine bleeding at any age
 Relief of PMS in perimenopausal women
 For women desiring contraceptive property
 Has an excellent safety profile, very well-tolerated &
practically without any undesirable side-effects

43.  Convenient dosage – twice or once weekly
 60 mg tablets twice a week ( for example, Sunday &
Wednesday) for 12 weeks followed by one tablet of 60 mg
once a week for another 12 weeks

44.  CDR Institute Lucknow 1991
 Once a week Non Hormonal
Contraceptive
 Marketed in India in 1992 as
Saheli and Choice-7 and
Centron
 Included in the National
Family Welfare Programme in
1995

45.  Study Population: Forty-two women with menorrhagia were recruited for the
study
 Dosage: Ormeloxifene was given to each patient 60 mg twice a week for 3
months and then once a week for 1 month. Patients were followed up at 2
and 4 months of therapy, then at 3 and 6 months after treatment was stopped
 Assessments:
 Menstrual blood loss (MBL) was measured objectively by a pictorial
blood loss assessment chart (PBAC) score and subjectively by a
visual analog scale (VAS)
J. Obstet. Gynaecol. Res. vol. 35, No. 4: 746–752, August 2009

46.  The pretreatment median PBAC
score was 388 (range 169–835)
 Median PBAC reduced to 80
(range 0–730) and 5 (range 0–
310) at 2 and 4 months,
respectively (p-value <0.001)
 The percentage reduction in
PBAC score - 97.7% at 4 months
J. Obstet. Gynaecol. Res. vol. 35, No. 4: 746–752, August 2009
Reduction in PBAC Score

47.  Amenorrhea with the
therapy – 18 patients
(42.9%)
 Adverse effects included
ovarian cyst (7.1%),
cervical erosion and
discharge (7.1%), gastric
dyspepsia (4.8%), vague
abdominal pain (4.8%) and
headache (4.8%)
J. Obstet. Gynaecol. Res. Vol. 35, No. 4: 746–752, August 2009
Percentage Reduction in PBAC ScorePercentage Reduction in PBAC Score
97.7%97.7%
2.3%2.3%

48. Journal of South Asian Federation of obstetrics and Gynaecology Jan –April 2011
.Study Population: 84 women attending gynae OPD in Belgaum India were
enrolled , 42 in each arm.
Dosage: Group A – 60 mg ormeloxifene twice a week for 3 consecutive cycles
and Group B – 10 mg MPA from day 5-25 for 3 cycles. All were made to use
same type of sanitary napkins and TVS done for ET before and after treatment
Data Analysis : Mean PBAC score and endometrial thickness were compared
Result: Mean PBAC score reduction of 85.7 % and 54% in group A and B resp
ET reduction was more in Ormeloxifene group but not statistically sign.
Conclusion: oremloxifene is more effective in reducing bleeding than MPA

49. 49
PBAC Score
(p = 0.0205)

50.  Indications
1. Puberty Mennorhagia
2. Postnatal Bleeding
3. DUB- after TVS r/o Ovarian Cyst
4. Mirena Users – immediate 3 months
 Dose- 60mg twice weekly for 3months.
 Effective upto 1 year after stopping it.

51. 1. Postmenopausal Bleeding
2. Endometrial Hyperplasia
3. Infertile patients
4. PCOS
Special mention:
1. In PMB , after balloon therapy – once a week
for 3 months
2. In hyperplasia – along with progesterone's

52.  Ovarian Cysts

54.  FIBROADENOMA
 BREAST MASTALGIA

56. Role of Ormeloxifene in benign Mastalgia of diverse origin
Paper No 779 presented by Dr. Subrat kumar Mohakul and Dr. Sujatha Guttala. on 18th
Jan 2013 at 56th AICOG 2013,

57. Ormeloxifene (Sevista) Product Monograph. Data on file.

58.  First Line of management of DUB should be
pharmaceutical
 Available medical modalities are far from satisfactory
 Important to individualize the treatment
 Mirena is the first line of treatment – Nice Guidelines
 Ormeloxifene is safe, efficacious, cheap and easy to
administer.

59. 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

60. Thank YouThank You
THANK YOU
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May be not the whole world but their world..