Reconvening Bangkok Conference

Bangkok, Thailand

New Contraceptive Technology March 8, 2010

Jeff SpielerSenior Technical Advisor for

Science and TechnologyOffice of Population and RH

USAID/Washington

TOPICS:

LAPMs

Sino-Implant (Zarin)

NES/EE Contraceptive Vaginal Ring

Depo-Provera SubQ

LNG-IUS

SILCS Diaphragm

Women’s Condom

New Contraceptive Methods Needed

Long-Acting & Permanent Methods

Zarin® (Sino-implant II)

Subdermal Contraceptive Implant

New hormonal implants:Comparison of Sino-Implant, Jadelle, Implanon

Sino-implant (II) Jadelle Implanon

Manufacturer Shanghai Dahua Pharmaceutical

Bayer HealthCare Schering Plough /Organon

Formulation 150 mg levonorgestrel

In 2 rods

150 mg levonorgestrel In 2 rods

68 mg etonogestrel In 1 rod

Mean Insertion & Removal time

Insertion: 2 min Removal: 4.9 min

Insertion: 2 min Removal: 4.9 min

Insertion: 1.1 min Removal: 2.6 min

Labeled duration of product use

4 years 5 years 3 years

Trocars Disposable Autoclavable /Disposable

Pre-loaded disposable

Cost of implant (US$)

$8.00 $21-23 $20

Cost per Year (if used for duration)

$2.00 $4.80 $6.70

Registration status of Sino-Implant

BurundiEthiopiaGhanaMalawiMali

ChinaIndonesiaKenya

In Progress (n=20)

Under Review (n=10) NepalPakistanRwandaTanzania Uganda

ArgentinaBangladeshBoliviaBrazilBurkina FasoChileColombiaDominican RepublicEcuadorFiji

IndiaMexicoMozambiqueNigeriaPeruRussia South AfricaSudanVenezuelaZimbabwe

REGISTERED (n=6)Sierra LeoneMadagascarZambia

NES/EE CVRNES/EE CVR

NES 150µg/EE 15 µg CVRNES 150µg/EE 15 µg CVR

Designed to last one year

The CVR is an effective, convenient, easily-used new contraceptive method.

Strengths Monthly ring-good for one year

Daily action not required Not coitus dependent Eliminates need for repeated

visits to doctor & pharmacy

Effective

Lack of androgen effect Weight /lipids favorable

High level of user satisfaction

Under a woman’s control She decides when to stop & start No need for a trained health

provider Rapid return to fertility if

desired

Challenges Medical risks & side effects

similar to currently available hormonal contraceptives

Additional safety requirements regarding effect of NCE on cardiac rhythm a new “requirement”- studies still to be done for NDA

Manufacturing process improvements underway - advancement from pilot scale production to development of commercial process – must be low cost!

New formulation of Depo-Provera: Depo-subQ Provera 104, for delivery with

Uniject

Depo-subQ Provera 104: New formulation for subQ injection 30% lower dose (104 mg vs. 150 mg) Rapid onset of action Same effectiveness, same length of protection

(>3 months) Approved by USFDA (2005) and UK Potential for home- and self-injection

Available for roll-out in 2011; Acceptability studies to begin in mid-2010

Uniject: Single dose, single package Prefilled, sterile, non-reusable Short needles for subQ injection (easier use by

non-clinical personnel/CHWs) Compact; easy to use and store

Potential “home run”

Oral contraceptives Intrauterine devices

• Highly effective

• Reduction of menstrual loss

• Reduction of pelvic inflammatory disease

• No daily motivation

• Long-acting

• Estrogen -free

• Rapidly reversible

Levonorgestrelintrauterine system

The Best of Both WorldsThe Best of Both Worlds

The levonorgestrel intrauterine system

Levonorgestrelintrauterine

system

Detail

Hormone cylinderRate-controllingmembrane

Uterinewall

Section ofsystem

Change in hemoglobin during 5 years of use

Years

Levonorgestrelintrauterine system

Cu IUD

0 1 2 3 4 5

3

2

1

0

-1

-2

-3

-4

g/l

SILCS Diaphragm: “One size fits most”

Firm insertion edge w/

soft spring in

rim for improved

comfort

Grip dimples and easy insertion

Cervical cup membrane

Fingertip dome for easy removal

Side viewTop view

Silocone rather than latexAppropriate for OTC useNo pelvic exam or fitting required

Silocone rather than latexAppropriate for OTC useNo pelvic exam or fitting required

Woman’s Condom

Insertion Capsule

Foam Ellipses

Condom Pouch

Outer Ring

Product Features

New Contraceptive Methods Needed

While tremendous success can be achievedby expanding access to existing methods,some additional methods would likely haveimmediate application if they were of low cost:

1. Non-hormonal, non-steroidal or non-estrogen or progestin oral contraceptives

2. New long-acting non-DMPA injectables in novel delivery systems

3. Biodegradable implants4. Non-surgical methods of male and female

sterilization5. Novel dual protection methods

Dual Protection

Ethiopia Sex WorkersU sed forpregnancyprevention

U sed for S T Dprevention

C onsistentC ondom U se

65% * 24%

H IV infec tionra te

55% * 86%

W ould not havesex w ith c lientw ho refuses touse condom s

54% * 10%

Reference: Aklilu et al, AIDS 2001, 15:87 -96

* p< 0.001