Posted by: vblaser | 11/18/2009

New contraceptive technologies highlight Uganda conference

Global Health Council Research Associate Rachel Hampton is at the International Conference on Family Planning in Kampala, Uganda. This is the first of her posts from the conference.

KAMPALA, Uganda – Family planning is often heralded as one of the top ten health achievements of the 21st Century. Contraceptives play a major role in this success, and new advancements in contraceptive technologies continue to make family planning more accessible to a broad audience of couples looking to space or delay births.  The first International Conference on Family Planning: Research and Best Practices — sponsored by Johns Hopkins Bloomberg School of Public Health, Makerere University School of Public Health, and the Bill & Melinda Gates Foundation – has brought together more than 1,000 people from all over the world to participate in a three-day long series of technical sessions, roundtables, workshops and presentations on family planning.

Monday was the first full day of the conference, and the morning started with a presentation from Laneta Dorflinger of Family Health International on research needs for contraceptive technology development. According to Dorflinger, current contraceptives are falling short, and new technologies are needed to meet the needs people in developing countries.

Some modern contraceptives can be difficult to use consistently and correctly and others might have side effects that lead to discontinued use, Dorflinger said. Men and women also have different reproductive needs throughout their lifespan, and need access to a variety of contraceptives to help them plan, space, and limit pregnancies. New technologies are needed to overcome these challenges and help to fulfill the unmet need for family planning. Dorflinger said that these new technologies should be user-independent, reversible, low-cost and broadly available. In addition, they should have minimal or no side effects or positive side effects that actually improve overall health. New products with these qualities could help to reach a new market of potential contraceptive users and recapture men and women who have discontinued use after dissatisfaction with current methods.

Eager to learn more about these new contraceptives, I left Dorflinger’s presentation and headed to a panel on new contraceptive technologies, which included presentations on a new implant, an over-the-counter diaphragm, a year-long ring, and an injectable contraceptive packaged in a one-dose, user-friendly device. According to conference participants, we can expect to see these projects on the world market over the next few years:

Sino-Implant (II): A contraceptive implant manufactured by Shanhai Dahua Pharmaceuticals in China. According to Ruth Merkatz of Population Council, the sino-implant is available at more than 60% less than the price of the other implants available on the market. It is registered in China, Indonesia, Sierra Leone and Kenya. More than 7 million implants have been distributed, and 11 published clinical trials show that this new device is safe and effective. The device will probably cost about $6 to $7. It is not currently seeking U.S. approval but is undergoing the approval process in several other markets.

SILCS Diaphragm: A one-size, easy to use, over-the-counter diaphragm produced by GHC member PATH. This new product eliminates the need for a fitting exam, and women can comfortably insert the device themselves at home with the assistance of written instructions. An effectiveness and safety study of the new diaphragm began in 2008 and is near completion in six sites across the United States. Evidence collected suggests that the majority of women can insert this device safely and position it correctly, suggesting that it will meet the criteria for OTC marketing.

NES/EE Contraceptive Vaginal Ring (CVR): A user-controlled CVR produced by the Population Council. Unlike other CVRs that can only be used for a month, this new CVR can be used for up to 13 cycles or one year, reducing costs and increasing user convenience. The NES/EE CVR is currently undergoing Phase III clincial trials to determine if it is safe and effective, and to assess cycle control, return to fertility and side-effects. Preliminary findings suggest this new device is highly effective in preventing pregnancy and has a safety profile that is similar to other contraceptives. Population Council aims for this contraceptive to hit markets in 2011.

Depo-subQ Provera 104 in the Uniject Device – A technology that packages a familiar injectable contraceptive into a one-use, prefilled injection system. The Uniject device is a “single, prefilled delivery service with subcutaneous needle.” It is basically like a pre-filled syringe that is only good for one use. The proper amount of depo-subQ provera 104 (similar to currently used depo but reformatted to fit the new device) is already loaded into the Uniject device, and can be injected under the skin rather than under the muscle. This new contraceptive technology will help to reduce waste (packaging) and improve safety (one-use needle), and is easier to deliver by nature of the pre-loaded Uniject device.

So, what do these new devices mean to developing countries? Well, many of these new contraceptives are more cost efficient and easier to use than other devices on the market. The SILCS diaphragm and the CVR are both user-controlled contraceptives than can be easily inserted by women and can be used again and again for many months. In addition, many of these new contraceptives could be easily distributed or delivered by community health workers.

The new packaging of depo, for example, makes it feasible for a community health worker to administer it directly. However, there are some caveats that still must be addressed. More information is needed on the removal of the implant, as some women may not come back at the appropriate time after insertion. In addition, the instructions to use the diaphragm are only written in English, which might be problematic for non-English speakers or illiterate populations.

Collectively, these new contraceptives represent a promising new variety of methods, both short-term to long-lasting, to help meet the needs of women during different stages of their reproductive lifespan.

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Responses

  1. Hello Folks,
    Thanks for the nice write up about the single-size diaphragm that is coming along through final stage clinical trials.
    Almost all this information is correct. But the last sentance is in error.
    PATH is not quoting a price for the SILCS diaphragm since we do not know the cost of the at this point. The diaphragm is only in pilot production. We still need to invest in manufacturing scale-up for introduction level volume. “Cost” is a tricky concept. It is comprised not just of manufacturing cost, but also needs to reflect cost of promotion, distribution, and programming. Please remove the last sentance. It is incorrect.
    Maggie K-B, SILCS Team Leader/PATH Seattle

  2. Thank you for your comment Maggie. We have removed the sentence you mentioned.

  3. Thank you very much for this update.

    Gislaine

  4. Hello Folks,

    Your comment about the “SILCS diaphragm instructions being available only in English” is incorrect.

    The SILCS instructions for use are comprised of simple pictorial and text instructions that were developed with input from user groups during product evaluations in the U.S., Thailand, South Africa, and Dominican Republic. In each study, the instructions were tested for comprehension in the local languages.

    Once the product is approved and market preparedness activities are underway, the instructions will be translated and pretested in various languages.

    Perhaps the instructions you saw at the Kampala conference were the instructions used for the SILCS conrtraceptive effectiveness study in the U.S. Those instructions included the additional information and warnings required by the US FDA for use in the U.S.

    Results from the pivotal are expected in 2010. After that, we hope to join with country partners who are interested in expanding access to female barrier methods to prepare for introduction of a single-size diaphragm in countries where it could help address women’s unmet need for barrier protection.

    Thanks again for your interest.
    Maggie K-B, SILCS Team Leader/PATH Seattle

  5. Dear Maggie,

    Thanks for that note on my entry. I am glad to hear that you tested the guidelines in local languages in your study sites in U.S., Thailand, South Africa, and Dominican Republic. I am also glad to hear that you have future plans to translate the insertion directions, and look forward to reading about the results.

    Rachel


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