For FIGO Faculty Use Only. DO NOT COPY OR DISTRIBUTE. At and Beyond the Horizon: New Technologies to Increase Choice and Address Unmet Need Panel on Unmet Need and Method Mix International Conference on Family Planning Addis Ababa, Ethiopia November 15, 2013 Jeff Spieler Senior Technical Advisor for Science and Technology Office of Population and RH Bureau for Global Health USAID/Washington

For FIGO Faculty Use Only. DO NOT COPY OR DISTRIBUTE. Topics in this presentation Rationale for improved and new methods At the horizon: Improved contraceptive technologies LNG-IUS Sayana Press (Depo subQ in Uniject) SILCS Diaphragm Woman’s Condom Beyond the horizon: New technologies NES/EE Contraceptive Vaginal Ring (CVR) Biodegradable Contraceptive Implants/Pellets Multi-Purpose Prevention Technologies (MTPs) New contraceptive methods Still Needed Future challenges

For FIGO Faculty Use Only. DO NOT COPY OR DISTRIBUTE. Client-level reasons for non-use, women with unmet need for FP, 3 regions Perceived subfecund, 2% Unaware of methods, 4% Health/side effects, 23% No access/high cost, 8% Infrequent sex, 21% Postpartum/breastfeeding, 17% Source: Darroch et al, Guttmacher Institute, 2011.

At the horizon (within 5 years): Improved contraceptive technologies LNG-IUS Sayana Press (Depo subQ in Uniject) SILCS Diaphragm Woman’s Condom

For FIGO Faculty Use Only. DO NOT COPY OR DISTRIBUTE. The LNG-IUS: The best of both worlds Highly effective/(when used correctly and consistently) Reduction of menstrual loss Reduction of pelvic inflammatory disease (PID) Highly effective No daily motivation Long-acting (up to 5 yrs) Estrogen-free Rapidly reversible Programs can apply to the International Contraceptive Access Foundation for free donations of the LNG-IUS at see http://www.ica-foundation.org/

For FIGO Faculty Use Only. DO NOT COPY OR DISTRIBUTE. Change in hemoglobin during 5 years of use

Hormonal Intrauterine Contraceptive System

For FIGO Faculty Use Only. DO NOT COPY OR DISTRIBUTE. New formulation of Depo-Provera: Sayana Press (Depo-subQ in Uniject) Depo-subQ Provera 104: New formulation for subQ injection New name 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 EMA/UK Uniject: Single dose, single package Prefilled, sterile, non-reusable Short needles for subQ injection – allows easier use by non-clinical personnel/CHWs Compact; easy to use and store Potential for home- and self-injection Approved by EMA and LDC registration forthcoming Available for roll-out in 2014; PK study on-going for injection in arm; acceptability studies completed 2013 Potential “home run” 8

Two new female barrier methods: SILCS Diaphragm and Woman's Condom Image Credit: PATH/Patrick McKern. Woman’s Condom Image Credit: PATH/Patrick McKern.

Beyond the Horizon (5-15 years): New Contraceptive Technologies New Technologies NES/EE Contraceptive Vaginal Ring (CVR) Biodegradable Contraceptive Implants/Pellets Multi-Purpose Prevention Technologies (MTPs) New contraceptive methods still needed

Nestorone® / Ethinyl Estradiol 1-Year Ring (Core Technology) NES/EE Contraceptive Vaginal Ring (CVR): First long-acting method that is user-controlled Nestorone® / Ethinyl Estradiol 1-Year Ring (Core Technology) NES Core *Delivers NES/EE 150/15µg /day, 13 cycles of 3 weeks on followed by 1 week off FDA approval expected in 2015 Developed by the Population Council Sponsored by USAID, NICHD, WHO NES / EE Core 8.4 mm (3/8”) in cross section 58 mm (2 1/4”) in diameter

Biodegradable Contraceptive Implant/Pellet Biodegradable Contraceptive Implant Pellets Effective contraceptive placed under the skin Similar to, but much smaller than, an implant Easy to insert Biodegradability would eliminate the need for removal at the end of one year BUT can be removed Landscape analysis of manufacturers underway (FHI360)

Priorities for first-generation MPTs “On demand” products: Used at the time of intercourse Appropriate for women who have intermittent sex, or who would like more direct control over their own protection Sustained release products: User-initiated, but do not require daily action Should increase adherence, and therefore overall effectiveness

New Contraceptive Methods Needed Some additional methods would likely have immediate application if they were of low cost: Non-hormonal, non-steroidal and/or non-estrogen containing OCs, or novel progestin-only OCs Non-surgical methods of male and female sterilization A highly effective and safe vaginal spermicide Post-testicular methods for men

For FIGO Faculty Use Only. DO NOT COPY OR DISTRIBUTE. Future Challenges Short Term – Improve programs and access, and help women successfully use current methods Medium Term - Improve current methods to address reasons for non-use, e,g., reduce side effects and make methods easier to use, including confidentially and during breastfeeding Long Term - Develop totally new methods to offer new approaches to contraception that address women’s reasons for unmet need and discontinuation