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Research

How Effective Are Spermicides?

While spermicides appeal to some women, users should not expect substantial protection.

Network: 2000, Vol. 20, No. 2

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Spermicides appeal to many women seeking contraception. In countries where they are available, obtaining them usually does not require a prescription or a provider's help. Using them is easy and sometimes can be done without a sexual partner's knowledge.

They can be used only when needed. And while they damage or kill sperm and may have minor localized side effects, spermicides have no effect on various systems throughout a woman's body. Finally, they come in different formulations, giving women a variety of choices: films, suppositories, gels, foams, creams or tablets.

However, spermicides used alone are among the least effective of modern contraceptives in preventing pregnancy. Pregnancy rates in typical use are about 26 percent in the first year.1 Thus, spermicides are more appropriate for women who cannot use other contraceptive methods or choose not to, and for women willing to risk an unintended pregnancy. Spermicide users should be informed about the use of emergency contraception as a backup, in case a spermicide was not used or was used incorrectly.

Furthermore, women should not expect sizable protection against sexually transmitted diseases, or STDs. Nonoxynol-9 (N-9) appears to provide modest protection against the bacterial STDs gonorrhea and chlamydia but studies are inconclusive about whether it protects against viral STDs, including HIV. [Editors's note: More recent research has indicated that N-9 is ineffective in preventing HIV and that it does not protect women against gonorrhea and chlamydia.] In fact, repeated use can irritate the vaginal lining, possibly increasing susceptibility to HIV. Research is under way to determine further the protection against disease provided by various existing spermicidal products, including those with benzalkonium chloride and octoxynol-9.

Determining effectiveness

How well do spermicides protect against pregnancy?

N-9 products have been available for more than 40 years, and rigorous clinical contraceptive testing of effectiveness was not required for their original approval by the U.S. Food and Drug Administration (FDA) in 1980. A 26 percent pregnancy rate during the first year of typical use reflects findings from studies that are difficult to compare and vary widely, with reported first-year typical pregnancy rates ranging from 0.3 percent to 37 percent.2

Pregnancy rates estimated for the first year of typical use, based on six-month data, were even higher in a recent FHI five-country study involving about 750 women. This study calculated annual pregnancy rates of 40 percent and 44 percent, respectively, among women using a spermicidal film containing a medium dose (72 mg) of N-9 and foaming tablets containing a high dose (100 mg) of N-9.3 When no contraception is used, about 85 percent of sexually active women become pregnant within a year.4

Contraceptive effectiveness of N-9 spermicides in various doses and formulations is the focus of a large study in the United States being conducted by FHI. This randomized, controlled trial of safety, contraceptive effectiveness, acceptability and consistency of use of various N-9 products will involve 1,800 women. The FDA has recommended that spermicide manufacturers be required to conduct full-scale clinical studies of products already on the market, but is awaiting results from the FHI study before making a decision.

Despite continuing attempts by researchers to provide more accurate pregnancy rates for spermicide effectiveness, FHI epidemiologist Dr. Markus Steiner emphasizes that these rates can be misleading. Rather than relying on such pregnancy rates, providers and clients should recognize that the effectiveness of spermicides -- like other barrier methods -- largely depends upon whether they are used correctly and consistently, he says.5 In general, spermicides are the least effective of contraceptive methods because people tend to use them incorrectly or inconsistently during typical use. Just how effective spermicides are during correct and consistent use (or perfect use) is difficult to measure because it requires participants to provide accurate and truthful information throughout a clinical effectiveness study.

Correct spermicide use as a contraceptive entails using spermicide each time intercourse occurs; placing the substance correctly in the vagina (on or near the cervix) no longer than one hour before intercourse; allowing adequate time for the spermicide to dissolve and disperse; using another application of spermicide if more than one hour has passed between insertion and intercourse; and not douching until at least six hours after sexual intercourse.

Because spermicides are often purchased at pharmacies or provided by community-based distribution, informing clients about their effectiveness and correct use can be challenging.

Use with other barrier methods

Whether using spermicides with other barrier methods increases contraceptive effectiveness is debatable. Widely varying results may reflect, as FHI's Dr. Steiner emphasizes, whether clients are using the methods correctly and consistently.

Using spermicide with cervical caps appears to improve somewhat the contraceptive effectiveness of the caps. One-year pregnancy rates for women using cervical caps with spermicide range from 5 percent to 21 percent, according to various studies.6 One-year pregnancy rates for typical use of cervical caps alone range from 20 percent for nulliparous women to 40 percent for parous women.

Whether use of a spermicide with a diaphragm increases or even decreases the contraceptive effectiveness of the diaphragm is unknown. In various studies, 12-month pregnancy rates have ranged from 10 percent to 21 percent for women using a diaphragm with spermicide.7 A 12-month pregnancy rate for typical use of the diaphragm alone ranges from 1 percent to 29 percent.

Typical use of a diaphragm without spermicide may actually provide more effective contraception than diaphragm use with a spermicide. The messiness, cost, and inconvenience of using spermicide with a diaphragm can discourage consistent diaphragm use. In addition, researchers have speculated that continuous use of a diaphragm would be less inconvenient, and perhaps more consistent, than the traditional use of diaphragms, with insertion occurring just before intercourse and removal recommended within 24 hours.

Two studies involving a total of 1,670 users, in which diaphragms were worn continuously (up to one year in one study and up to four years in the other) show excellent contraceptive protection rates. Using diaphragms continuously without spermicides resulted in pregnancy rates of 3 percent and 1 percent a year, respectively.8 However, an FHI-sponsored study conducted among 110 women by the London-based Margaret Pyke Centre of a continuously used diaphragm over 12 months without spermicide found a 24 percent annual pregnancy rate.9 In all three studies, diaphragms were briefly removed for cleaning each day at least six hours after intercourse, then immediately reinserted.

Other studies have found that use of a diaphragm in the traditional way -- with spermicide and with insertion just before intercourse -- is associated with lower pregnancy rates than continuous use of a diaphragm without spermicide. However, no significant difference has been demonstrated.10 In general, no differences in discontinuation due to medical reasons have been observed between the two modes of diaphragm use.

Continuous use of a diaphragm without spermicide is considered an experimental method and is not recommended for general use.

Whether the use of spermicide with condoms should be promoted also has been the subject of debate and investigation. Concerns have focused on whether promoting spermicide use with condoms might reduce condom use.

One FHI study looked at how spermicide availability affected male condom use among three groups of Colombian prostitutes. The first group used condoms only, the second group used spermicides with condoms, and the third group was assigned to use spermicide as a backup if a condom was not used. All participants were instructed to use a condom at every act of intercourse. Researchers found that half of women in the condom-only group -- and nearly 40 percent of women in the spermicide and condom group -- reported using condoms for every act of intercourse. However, fewer than 5 percent used condoms among the women assigned to use spermicide as a backup when condoms were not used. "The lower level of consistent condom use reported among this group is of programmatic concern," concluded the study's authors. "Sex workers may be less motivated to negotiate condom use if spermicides are presented as an option to potential customers."11

Use of spermicides with female condoms is possible, but no studies have been conducted comparing the effectiveness of female condom use alone versus female condom use with spermicides. (The lubricant that is supplied with female condoms is not spermicidal.)

The spermicide used in contraceptive sponges is considered to be the primary means of pregnancy prevention. Consequently, sponges are not used without spermicides.

Health effects

The most common problem associated with spermicide use is skin irritation of the female or male genitalia. Usually irritation is temporary, and stops when spermicide use is discontinued. Persistent use of spermicides can also disrupt the vaginal lining.

Use of N-9 spermicide also appears to increase a woman's risk of urinary tract infection (UTI), characterized by painful, urgent or more frequent than normal urination. Increased risk of UTI has been found in women using diaphragms with spermicide,12 in women using spermicide-coated condoms,13 and in women using spermicide alone.14 Spermicides appear to change the normal vaginal environment. These changes allow microorganisms such as Escherichia coli -- the most common cause of UTI -- to thrive and attach to the mucous membrane of the vagina more easily.15

Notably, more frequent use of diaphragms with spermicide and of spermicide-coated condoms has been strongly associated with increased risk of UTI among sexually active young women participating in two U.S. studies.16 Whether more frequent use of spermicide alone also increases UTI risk requires further research.

Guidelines are not available to help providers counsel clients about their risk of UTI as it relates to frequent spermicide use. "However, providers should alert clients using spermicides alone or with other barrier methods to their increased risk of UTI," says Elaine Murphy, senior program advisor at the U.S.-based Program for Appropriate Technology in Health and cochair of a U. S. Agency for International Development (USAID) committee on client-provider interaction. "They should inform women of the signs and symptoms of UTI and what to do if they experience such symptoms. Providers also should be able to refer women with UTI for treatment. Women with recurrent UTIs should be advised to consider using another form of contraception besides spermicide."

Disruption of the vaginal environment also has been associated with bacterial vaginosis. This common vaginal infection is considered a risk factor for more serious pelvic and obstetric conditions. However, evidence suggests that spermicide use decreases risk of bacterial vaginosis. In the laboratory, various spermicides -- including N-9, benzalkonium chloride and menfegol -- kill a variety of microorganisms associated with bacterial vaginosis.17 In a study of some 180 women, 66 of whom used N-9 spermicide, a significantly reduced prevalence of bacterial vaginosis was associated with spermicide use (15 percent), compared with those who were not using spermicide (31 percent).18 More research is needed to clarify this issue.

Use of N-9-impregnated sponges has been associated with vaginal yeast infection due to overgrowth of Candida albicans.19 Data are conflicting about the association between spermicides used alone and yeast vaginitis.20

Acceptability

Spermicides that people like to use and accept will be used more consistently, making the contraceptive method more effective in typical use. Should a spermicide also prove to protect against STDs significantly, its acceptability would become even more critical.

Various studies are under way to assess the acceptability of spermicidal products. Foam spermicide, for example, was found to be excessively messy and produced too much lubrication in an FHI study conducted in collaboration with researchers at University Teaching Hospital in Lusaka, Zambia, among 114 women and 150 men attending an STD clinic. Foam was less desirable than both suppositories and foaming tablets.21

In another spermicide acceptability study conducted by FHI among 162 family planning clinic clients in Kenya, the Dominican Republic and Mexico, women preferred contraceptive film over foaming tablets. Again, the messiness and wetness associated with tablets were unacceptable to many women.22

In focus group discussions, 77 low-income Mexican women said that sperm-icides were the least bothersome of the barrier methods. But most women felt that barrier methods, including spermicides, tended to interrupt intimacy because they were inserted immediately prior to use. The authors of the study noted that while female barrier methods can be inserted immediately prior to use, "it appears that in this community, the timing of intercourse is often difficult to anticipate, and a man cannot be relied on to be patient while a woman prepares herself."23

"The use of spermicides in Mexico is low," confirms Dr. Susana Bassol, head of the Department of Biology of Reproduction, Centro de Investigación Biomédica in Torreón, Mexico. "First, spermicides are not distributed by family planning programs and they are too expensive for most women to buy. Spermicides also are associated with relatively high pregnancy rates. Providers recommend them only in special cases, such as to women who are switching methods or breastfeeding for a short time."

In Kenya, "there is a negative perception of spermicides by clients who think they are messy, irritating, cause delays before sexual intercourse, and have high failure rates," says Nester Theuri, programme coordinator of the reproductive health department for Kenya's family planning private sector. "Also, many women, especially rural women, feel uncomfortable having to touch their reproductive parts in order to use spermicides.

"Furthermore, there is lack of proper education about spermicides. Health providers do not seem very keen to give spermicides as a family planning method and so do not counsel clients properly about them."

That spermicides are not used widely in Kenya is further explained by their cost. Spermicides supplied through commercial sources are expensive, particularly when women choose to combine them with another method to protect themselves better against pregnancy or sexually transmitted diseases.

The situation is similar in neighboring Uganda. "Not many women -- especially if they are married -- use spermicides," says Allen Nankunda, communication specialist with the Delivery of Improved Services for Health Project, a joint project of the government of Uganda and USAID. "Family planning clients tend to prefer methods that are more long-term, easier to use and more effective. It is the unmarried adolescents who are more likely to use spermicides."

In Nepal, spermicides have been available since 1983. However, government health clinics do not supply them. And, while both vaginal foaming tablets and films are available, their use is very low, says Kamala Moktan of FHI, a registered nurse in that country.

-- Kim Best

References

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  2. Hatcher, 803-9.
  3. Raymond E, Dominik R, The Spermicide Trial Group. Contraceptive effectiveness of two spermicides: a randomized trial. Obstet Gynecol 1999;93(6):896-903.
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  6. Hatcher, 814-16.
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  16. Hooton, Scholes, Hughes; Fihn.
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  19. Rosenberg MJ, Rojanapithayakorn W, Feldblum PJ, et al. Effect of the contraceptive sponge on chlamydial infection, gonorrhea, and candidiasis. A comparative clinical trial. JAMA 1987;257(17):2308-12.
  20. Geiger AM, Foxman B. Risk factors for vulvovaginal candidiasis: a case-control study among university students. Epidemiology 1996;7(2):182-87; Barbone F, Austin H, Louv WC, et al. A follow-up study of methods of contraception, sexual activity, and rates of trichomoniasis, candidiasis, and bacterial vaginosis. Am J Obstet Gynecol 1990;163(2):510-14.
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