Project

Sino-implant (II)

Globally, 225 million women in developing countries have an unmet need for safe and effective contraception. Hormonal contraceptive implants, introduced more than 30 years ago, are one of the most effective family planning methods developed to date. Despite their strong safety profile and popularity, their high cost has been a barrier in many countries until recently.

The Sino-implant (II) initiative has been at the forefront of helping to increase access to affordable, high-quality implants in resource-limited settings. As a long-acting family planning method, implants are ideal for women living in countries where access to health services is limited.

Sino-implant (II) is a highly effective, low-cost, subdermal contraceptive implant composed of two thin, flexible, silicone rods and is marketed under the global brand name Levoplant. Each rod contains 75 mg of levonorgestrel, a synthetic progesterone. The implants are inserted under the skin of a woman's arm by a trained health care provider. Sino-implant (II)/Levoplant is manufactured in China by Shanghai Dahua Pharmaceuticals Co., Ltd. The product has been registered in more than 20 countries worldwide, and the manufacturing facility is deemed in compliance with World Health Organization (WHO) Good Manufacturing Practices (GMP). In November 2016, the United Nations Population Fund (UNFPA) approved Sino-implant (II)/Levoplant for purchase by its country programs through the WHO Expert Review Panel process. In June 2017, the product was prequalified by WHO. WHO prequalification will now allow additional donors to purchase the product for country programs; registrations at the national level are currently being updated.

FHI 360 provides technical assistance to facilitate the global introduction of Sino-implant (II)/Levoplant, including conducting independent quality testing, negotiating public-sector price-ceiling agreements, supporting the WHO prequalification application process and working with distributors to secure national regulatory approvals. FHI 360 also leads a clinical trial in the Dominican Republic, which will supplement existing clinical evidence, and collaborated on post-marketing surveillance studies in four countries with support from the Bill & Melinda Gates Foundation and the U.S. Agency for International Development (USAID). FHI 360 works in close coordination with a number of organizations, including government officials, distributors and service delivery groups, to facilitate introduction at the country level.

For more information, please email us.

Resources

  • Sino-implant (II)/Levoplant Overview
    August 2017 — This four-page document, developed for policymakers, donors, program managers and others considering adding Sino-implant II/Levoplant to a country’s method mix, provides answers to key questions about the product and...
  • Sino-implant (II): Dahua brochure
    2017 — This product brochure provides an overview of Sino-implant (II), Shanghai Dahua Pharmaceuticals, Ltd.’s two-rod contraceptive implant. The product is sold under the global brand Levoplant as well as other trade names, including...
  • Levoplant Reference Guide for Healthcare Providers
    July 2017 — This resource for health care providers offers an overview of Levoplant, a two-rod contraceptive implant containing levonorgestrel. The guide provides clinical information about the product and describes insertion and removal...
  • Sino-implant (II) Initiative: 2016 Quality Assurance Evaluation
    2016 — FHI 360 acts as an independent third party to assess the quality of Sino-implant (II). A quality assurance evaluation and monitoring program was implemented by FHI 360 to verify that Sino-implant (II) meets lot release specifications...
  • Sino-implant (II) Project Fact Sheet
    December 2016 — Contraceptive implants are a highly effective, safe, long-acting and popular contraceptive method shown to be acceptable to women worldwide. They are also ideal for women with limited access to health care...
  • Contraceptive Technology Innovation brochure
    2016 — Throughout our 40-year history, FHI 360 has helped increase access to family planning by developing, evaluating and introducing a range of new contraceptive methods. Research is under way to develop innovative mid- to long-...
  • Implants Toolkit
    2015 — Hormonal implants consist of small, thin, flexible rods, each about the size of a matchstick, that contain levonorgestrel, a synthetic progesterone. They are a safe, highly effective and quickly reversible long-acting method ...
Funder: Bill & Melinda Gates Foundation
Duration: 2009 - 2018