Reconvening Bangkok Conference Bangkok, Thailand New Contraceptive Technology March 8, 2010 Jeff Spieler Senior Technical Advisor for Science and Technology Office 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)JadelleImplanon ManufacturerShanghai Dahua Pharmaceutical Bayer HealthCareSchering 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 years5 years3 years TrocarsDisposableAutoclavable / 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 Burundi Ethiopia Ghana Malawi Mali China Indonesia Kenya In Progress (n=20) Under Review (n=10) Nepal Pakistan Rwanda Tanzania Uganda Argentina Bangladesh Bolivia Brazil Burkina Faso Chile Colombia Dominican Republic Ecuador Fiji India Mexico Mozambique Nigeria Peru Russia South Africa Sudan Venezuela Zimbabwe REGISTERED (n=6) Sierra Leone Madagascar Zambia

NES/EE CVR

NES 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: tNew formulation for subQ injection t30% lower dose (104 mg vs. 150 mg) tRapid onset of action tSame effectiveness, same length of protection (>3 months) tApproved by USFDA (2005) and UK tPotential for home- and self-injection tAvailable for roll-out in 2011; Acceptability studies to begin in mid-2010 Uniject: t Single dose, single package t Prefilled, sterile, non-reusable t Short needles for subQ injection (easier use by non-clinical personnel/CHWs) t Compact; easy to use and store Potential “home run”

The Best of Both Worlds

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 view Top view Silocone rather than latex Appropriate for OTC use No 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 achieved by expanding access to existing methods, some additional methods would likely have immediate 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 implants 4. Non-surgical methods of male and female sterilization 5. Novel dual protection methods

Dual Protection