Innovation Update

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2 Popular EC Products
PC4
Schering
Postinor-2
Gedeon
Richter
Progestin-alone EC has
Better Effectiveness
Pregnancy rates (per episode)
Levonorgestrel (LNG)
1.1%
Yuzpe (Combined
Formulation)
3.2%
Progestin (LNg)-Alone EC
has Fewer Side Effects
Vomiting
Nausea
LNg
5.6%
23.1%
Yuzpe
18.8%
50.5%
Source: WHO 1998
The Necklace
Standard Days Method
Efficacy of SDM
Pregnancy rate
over 13 cycles
Correct use (w/abstinence)
4.4
Correct use
(abstinence + other method)
5.6
Correct + non-compliance
11.9
• “Generally regarded as safe (GRAS)”  reclassify as
active pharmaceutical ingredient
• Inexpensive, widely available, stable at several
temperatures
• Sulphated polymer – high molecular weight, negatively
charged – may block binding of pathogens to target
cells
Carraguard - PC-515 (1)
• Population Council’s lead
microbicide
• Derived from seaweed
(carrageenan)
• Carrageenans used widely in
food, pharmaceuticals &
cosmetics as excipient
Microbicides in clinical trials
Sept. 2002
10
8
6
4
2002
2
0
Phase 1
Phase 2
Phase2/3
Phase 3
When will we actually see a
microbicide product for use in
programs?
Not for at least several
years.
Female Condom
Plastic sheath
with ring
at both ends
Outer ring
Inner ring
Grasping female condom
for insertion
Reality and Reddy Female
Condoms
Auto-Disable (AD) Syringes
•
•
•
•
•
Automatic inactivation after single use
Difficult / impossible to re-use
Slightly more expensive
Successful experience in immunization
Starting to be shipped by USAID for DepoProvera
What country in ANE/E&E has
already had Depo shipped with
AD Syringes?
Jordan!
What ANE/E&E countires are
Scheduled for AD Syringes in
2002-3?
• Afganistan, Bangldesh, Jordan,
Nepal, Philippines, Egypt, WB
Gaza
• Albania, Romania
CBD Workers….
A. Can provide condoms
B. Can provide condoms and pills
C. Can provide condoms, pills and injectables
D. Can provide condoms, pills and injectables
but certain quality components (e.g. side
effect counseling, clean needle) key
N-9 Spermicides..
A. Very effective for preventing pregnancy and
HIV.
B. Very effective for preventing pregnancy but
not HIV.
C. Effective against HIV but not pregnancy.
D. Mediocre against pregnancy and not
effective against HIV.
Non-Menstruating FP Clients
A. Are only a small part of potential FP users.
B. Should be told to go away and return when
they are menstruating
C. Should be given condoms and told to return
when they are menstruating.
D. Can be given hormonal methods if
pregnancy is ruled out e.g. by the “Pregnancy
Checklist.”
Syndromic Management of
STIs
A. Not a sound approach to SITs
B. Not a sound approach for cervical STI’s in women
such as gonorrhea and chlamydia, but effective for
urethritis, and often for genital ulcers. May be
sensible approach to vaginitis
C. Good for all STI syndromes
D. A good approach for social marketing antibiotics
for urethritis.
According to WHO, how many pill
packs should be given at initial visits?
A. 1 Pack
B. 3 Packs
C. 6 Packs
D. Up to 13 Packs (1 year)
E. As many as client wants
IUDs
A. Can be safely provided to nulliparous
women with proper screening
B. Require a follow-up only at about one month
unless the client has problems
C. May be appropriate for HIV+ women
D. Do not increase the risk of infertility in wellscreened clients.
Nonfatal Venous
Thromboembolism May be More
Common with Third Generation Pills
Rate
(per 100,000
women/years)
Situation
5 - 11
No COC
COC with Desogestrel or Gestodene (3rd
generation)
30
COC with Norethisterone or Levonorgestrel
15
Pregnant and postpartum women
60
Source: Vessey MP. BJOG 1997; 104:516.
Types of Monthly
Combined Injectables
Cyclofem
(Cyclo-Provera):
Mesigyna
(Norigynon):
25 mg DMPA
5 mg estradiol cypionate
50 mg NET-EN
5 mg estradiol valerate
Comparative Characteristics of
DMPA and NET-EN
DMPA
Effectiveness
Bleeding
Needle/pain
Reinjection window
Duration
Cost
NET-EN
(no significant difference)
More amenorrhea
Smaller/less
2 - 4 weeks early or late
More irregular
Larger/more
1 - 2 weeks early or late
3 months
2 months
Less expensive
More expensive
4 mm
(1/8 in)
54 mm
(2 inches)
EC:The Sooner the Better
WHO Pooled Data (Yuzpe and LNg)
5.0%
4.1%
4.0%
p<.01
3.0%
2.6%
Pregnancy
Rate 2.0%
1.0%
3.1%
1.5%
1.8%
0.5%
0.0%
0-12
13-24
25-36
37-48
49-60
61-72
Source: Piaggio, von Hertzen, Grimes and Van Look 1999
Actual Return of Menses
Compared with Expected Return
70%
60%
50%
40%
WHO
Pop Council
30%
20%
10%
0%
<-3
-3 to +3
+4 to +7
>+7
Source: WHO 1998; Ellertson et al. 2001
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