Wider access eyed for contraceptive sponge

Women who are interested in nonhormonal contraception will see wider access to the Today contraceptive sponge now that a new company is in charge of its marketing and distribution.

Synova Healthcare Group of Media, PA, has acquired the exclusive worldwide rights to the Today brand contraceptive sponge from Allendale (NJ) Pharmaceuticals. Allendale Pharmaceuticals will continue to operate as a wholly owned subsidiary of Synova.

Look for a new consumer advertising campaign, as well as physician outreach, to begin soon, says David Harrison, Synova's chief operating officer. There has been a whole generation of women who really have not been exposed to the Today sponge, Harrison says. "What we want to do is to introduce it to that segment and introduce it as a contraceptive option," he says. "We also want to broaden access via the physician community because similarly, there has been a whole generation of physicians who have not been presenting the sponge as an option to their patients."

Allendale Pharmaceuticals originally acquired manufacturing and marketing rights to the sponge in 1999 after the product had been shelved by its first owner, Whitehall-Robins Healthcare of New York City. Whitehall-Robins ceased manufacture of the device in 1994 when it determined it cost too much to correct problems caused by water quality issues at the factory where the sponge was made. Allendale worked with the Food and Drug Administration (FDA) to update labeling and manufacturing for the over-the-counter contraceptive, with final approval won in April 2005.

Pricing for the product will remain competitive with similar contraceptives, says Harrison. It currently sells for about $7.99 per three-pack at such retail outlets as CVS, Drug Mart, Drug Fair, Pathmark, Publix, Rite Aid, Target, Walgreens, and Wal-Mart, as well as Internet resources such as Amazon.com and Drugstore.com.

Weigh the options

The Today Sponge is circular in shape, 2 inches in diameter and three-quarters of an inch thick, with an attached loop. Made of polyurethane, it contains 1,000 mg of the spermicide nonoxynol-9 (N-9). It is moistened with tap water prior to use and inserted deep into the vagina. Removal is achieved by pulling the attached loop.

A single Today Sponge allows for as many acts of intercourse as desired within a 24-hour timeframe without the need to change protection. According to the company's product information, the Today sponge should not be left in place for more than 30 hours after insertion (which includes the six-hour waiting period after the last act of intercourse). It should not be used during menstruation, immediately after childbirth, miscarriage, or other termination of pregnancy, or by a women who has ever been diagnosed with toxic shock syndrome; a physician should be consulted in such cases, the company advises. Women using the sponge who experience two or more of the warning signs or symptoms of toxic shock syndrome — including fever, vomiting, diarrhea, muscular pain, dizziness, or rash similar to sunburn — are advised to contact a provider immediately.

While vaginal barriers such as the contraceptive sponge are relatively simple to use and can be used with little advance planning, consistent and correct use is essential, state the authors of Contraceptive Technology. Most pregnancies occur because the method is not used, they state.1 One-fifth of parous women will experience an unintended pregnancy in the first year of perfect use; that number rises to 40% in typical use. Nine percent of nulliparous women will experience an unintended pregnancy in the first year of perfect use; 20% with typical use.1

In a 2003 review of available data,2 the sponge was found to be statistically significantly less effective in preventing overall pregnancy than was the diaphragm in the two trials that met analysts' inclusion criteria, one performed in the United States3 and one in the United Kingdom (UK).4

The 12-month cumulative life table termination rates per 100 women for overall pregnancy were 17.4 for the sponge vs. 12.8 for the diaphragm in the U.S. trial, and 24.5 for the sponge and 10.9 for the diaphragm in the UK trial. Discontinuation rates at 12 months were higher with the sponge than with the diaphragm.2

Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed in the two studies. In the U.S. trial, the 12-month cumulative life-table discontinuation rate for allergic-type reactions per 100 women were 4.0 for the sponge, vs. 0.7 for the diaphragm. The corresponding figures from the British trial were 0.9 and 0.0. Allergic-type complaints included dermatitis, erythema, and irritation, with vaginal itching as the chief discomfort-related complaint.2

Help women to assess their risk of sexually transmitted disease (STD) exposure when choosing the sponge as a contraceptive method, advise authors of Contraceptive Technology. The sponge does not protect against STDs; encourage condom use for protection, they state.1

References

  1. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology: 18th revised edition. New York City: Ardent Media; 2004.
  2. Kuyoh MA, Toroitich-Ruto C, Grimes DA, et al. Sponge versus diaphragm for contraception: A Cochrane review. Contraception 2003; 67:15-18.
  3. Edelman DA, McIntyre SL, Harper J. A comparative trial of the Today contraceptive sponge and diaphragm. Am J Obstet Gynecol 1984; 150:869-876.
  4. Bounds W, Guillebaud J. Randomised comparison of the use-effectiveness and patient acceptability of the Collatex (Today) contraceptive sponge and the diaphragm. Br J Fam Plann 1984; 10:69-75.