ULIPRISTAL

WHERE DO WE STAND?
 UTERINE FIBROIDS
5 mg daily for 12 to 13 weeks
 EMERGENCY CONTRACEPTION
30 mg within 5 days of unprotected
intercourse
Other possible uses
 Reduction in endometriosis pain
 Reduced unscheduled bleeding in women
having etonorgestrel implantation and
reduces discontinuation of treatment
 FIBROIDS >3CM
 WOMEN WITH HEAVY BLEEDING
 Hb <10g/l
 TO ALLIEVIATE SYMPTOMS
 PRETREATMENT TO ASSIST SURGICAL
REMOVAL
 5 MG/DAY FOR 3 MONTHS FOLLOWED BY A

MINIMUM BREAK OF 2MONTHS
 10 MG/ DAY FOR 3 MONTHS WITH A BREAK
OF 2 MONTHS
 Selective progesterone receptor modulator
binds and prevents natural progesterone
 Direct action on fibroids by inhibition of cell
proliferation and induction of apoptosis
 Antagonist for glucocorticoid receptor
 Inhibits ovulation
 In luteal phase decreases makes
endometrium inhospitable for implantation
 HEADACHE
 NAUSEA
 FATIGUE
 HOT FLUSHES
 BREAST PAIN
 FUNCTIONAL OVARIAN CYST
 ACNE
 SWEATING & MUSCLE PAIN
 THICKENING OCCURS BUT
REVERSES AFTER STOPPING
 INCIDENCE OF HYPERPLASIA
DID NOT INCREASE
 INVESTIGATION WARRANTED
IF BLEEDING PATTERNS
CHANGE /THICKENING
PERSISTS 3 MONTHS ATER
STOPPING ULIPRISTAL
UPA WAS INVESTIGATED IN
4 PHASE 3 TRIALS CALLED
PEARL STUDIES
 Progesterone receptor modulator associated
endometrial changes
 Inactive weekly proliferating epithelium
 Asymmetry of stromal and epithelial growth
 Prominent cystically enlarged endometrial
glands which simultaneously exhibit the
epithelial effect of estrogen and gestagen
 Increased apoptosis and compact stroma
 Double blind placebo controlled study
in which women were randomised in
the ratio of 2:2:1 to 5 mg/day& 10
mg/day ulipristal & placebo
 End points
• reduction in PABC <75( 90%with UA &19% with
placebo)
• change in fibroid volume from baseline to 13
weeks(20% with UA &3% with placebo)
 Secondary end points were
amenorrhea pain relief and quality of
life improvement
 Double blind randomised double dummy active
controlled phase 3 trial.
 1:1:1 of 5 mg:10 mg:3.75 leuprorelin injection
 Primary endpoint PABC <75 and estradiol levels
at the end of treatment
 Secondary end points fibroid volume pain
quality of life and haemoglobin levels.
 PABC <75 in 90 to 98 % of UA & 89% of
leuprorelin
 Hot flushes 24 to 26% in UA & 65 % WITH
LEUPRORELIN
 Showed that ulipristal is not inferior to
leuprorelin but has superior tolerability
 Long term multicenter trial evaluating
sustained intermittent treatment with four
repeated 3 month course of UA 10 mg/day
for moderate to severe symptoms.
 Single course 78% became amenorrhoeic.
 Extension course 89% became amenorrheic.
 Median reduction in fibroid volume 45% with
single course and that after 4 courses its72%.
 Double blind parallel group trial involving 46
centers to assess sustained efficacy safety
and tolerability of repeated 12 week courses
of 5 or 10 mg UA
 1:1 OF 5 mg &10 mg UA
 Rate of amenorrhea after cycle 4 was 69% in
5mg and 74% in 10 mg
 67% reduction of fibroid volume
 No difference in PABC scores and pain scores
 Clinically significant reduction in volume 25%
in both groups
 PEARL 2 3 &4 had no placebo control
 Women with maximum utrine size 16 weeks
& fibroid size 12 cm have been included
 Trials mostly conducted in EUROPEAN centers
did not include significant black women in
whom fibroids are significantly prevalent
 Can patients treated with UA become
pregnant?
 Is pregnancy following UA is associated with
complications?
 Does fibroid in infertility be treated with UA
alone for achieving pregnancy?
 Cassandra and others made a systematic
reviews of 7 studies and reported about 24
post UA pregnancies
 UA alone or in conjunction with surgery
permit conception and favourable outcome
 No pregnancy related complications or
teratogenic effects are reported till date
 Still more studies are needed to establish
safety of UA as a treatment of symptomatic
fibroid prior to pregnancy
MENORRHAGIA VOLUME FERTILITY
REDUCTION
UAE 80 to 90% 50 to 60% REDUCED
UA 75% 45 to 72% NOT AFFECTED

 FEB 2018 PRAC (Pharmacovigilance Risk
Assessment Committee) issued temporary
recommendations that no new patient be
started on UA
 Now the committee concluded that new
patients can start treatment with the latest
recomendations
 Liver Function to be done
 before starting treatment course
 once a month during first two treatment
courses &
 2 to 4 weeks after stopping treatment
 Women who are eligible for surgery shall be
given only one course
 Women who are not eligible for surgery shall
receive more than one course
 ASTHMA
 PREGNANCY
 LACTATION
 PATIENT ON GLUCOCORTICOID TREATMENT
 LIVER DISEASES
 OVARIAN CYST
 GENITAL MALIGNANCIES
TYPE 1 FIBROID >3CM TYPE 2 FIBROIDS OR
OR WITH ANAEMIA MULTIPLE TYPE 2-5 FIBROIDS
a. women with desire

a. one or two to have children
treatment TWO 12 week course
intervals with b. women who don’t
UA is wish to have
considered. children or
b. if good perimenopausal
response FOUR 12 week course
surgery is
avoided.
CONCLUSION
no confusion……
SPRM Ulipristal acetate
still presents new perspectives
particularly
for
SYMPTOMATIC FIBROID
PATIENTS
WHO WISH TO RETAIN
THE ORGAN
FOR WHOM FERTILITY IS
A PRIORITY

ULIPRISTAL

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WHERE DO WE STAND?

 5 MG/DAY FOR 3 MONTHS FOLLOWED BY A

4 PHASE 3 TRIALS CALLED

UAE 80 to 90% 50 to 60% REDUCED

UA 75% 45 to 72% NOT AFFECTED

a. women with desire

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