December 2007

Innovative Contraceptive Gels and Sprays Enter Clinical Testing

Many women are dissatisfied with their current contraceptive choices. Thirty-one percent discontinue use of reversible contraceptives for method-related reasons within six months of starting to use them, and 44 percent have abandoned their chosen method within a year.

New products would allow women to apply contraceptive spray or gel to a forearm or leg or to the abdomen.

More than 100 million married women in the developing world who do not want to become pregnant are not practicing contraception. Many lack access to reproductive health services and, for many, the current contraceptive options are unsuitable for their day-to-day lives. Young women just entering their reproductive years who want to have small families will need to rely on contraceptives for an average of 30 to 35 years (from their late teens until they are about 50). The current unmet need for contraception, combined with anticipated future need, makes expanding the choice of safe, effective, and inexpensive methods critical.

The Population Council is testing two innovative transdermal delivery systems: a gel product, developed in collaboration with Antares Pharma of Santiago, Chile, and a spray-on method, produced in partnership with Acrux Limited of Australia. Both products contain Nestorone®—a versatile synthetic progestin similar to the natural hormone progesterone—which has been studied extensively by Council scientists. Nestorone can be used in rings, patches, gels, and implants and, combined with estrogen or used alone, for contraception or hormone therapy. The spray represents the first non-oral contraceptive developed to deliver natural estrogen in combination with Nestorone. One advantage of this approach is that the risk of venous thromboembolism (blood clots) is four times lower with transdermal delivery than with oral delivery of the compound.

If proven safe and effective, both methods would be affordable, reversible, and easy to use. They are applied to and absorbed through the skin and take advantage of the skin’s ability to deliver substances into the bloodstream. Because they are not used orally, both methods are particularly appropriate for use by breastfeeding mothers.

Dose-finding studies of Nestorone delivered via the gel indicate that a sufficient amount of the molecule can be delivered through the skin to inhibit ovulation. Earlier studies showed that the gel is well accepted by women and easy for them to administer.

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1 December 2007