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  1. 1

    WHO / CONRAD Technical Consultation on Nonoxynol-9, World Health Organization, Geneva, 9–10 October 2001. Summary report.

    World Health Organization [WHO]; Eastern Virginia Medical School. Contraceptive Research and Development Program [CONRAD]

    Geneva, Switzerland, WHO, 2003. [27] p. (PN-ACQ-110)

    An effective, easy to use vaginal microbicide would provide women with a method under their own control with which to protect themselves against infection with the human immunodeficiency virus (HIV). While many novel compounds are currently being developed and tested, it will be many years before a new product can be fully evaluated and distributed to users. The spermicide Nonoxynol-9 (N-9) has been widely available as a contraceptive for many years and has been shown to be effective against HIV in laboratory studies. If it also provided effective protection against HIV in clinical studies, N-9 could be made rapidly available to women who require protection. The World Health Organization Global Programme on AIDS (GPA) and the Joint United Nations Program on HIV/AIDS (UNAIDS) sponsored a clinical trial of a gel containing N-9 to assess its effectiveness in protecting against HIV. Preliminary results from the study were presented in July 2000 at the 13th International AIDS Conference in Durban, South Africa, and showed, contrary to expectation, that the HIV incidence was higher in women using N-9 than in women using a comparison product. While a disappointment with regard to the rapid deployment of an effective microbicide, these results also raised questions about the safety of N-9 when used for its main indication, protection against unwanted pregnancy. After presentation of the preliminary results from the study in July 2000, the World Health Organization (WHO) was approached to provide an assessment of the scientific information regarding the safety and effectiveness of N-9 when used for family planning purposes. This summary should permit Member States to assess the risks and benefits of N-9 use among women in their country who may be at risk of HIV infection from inadequately protected sexual activity. Accordingly, the WHO Department of Reproductive Health and Research (RHR) convened a Technical Consultation in October 2001, in partnership with the CONRAD Program, Arlington, VA, USA, to review the available evidence and provide advice to member states on the use of N-9. The Consultation included experts from developed and developing countries with experience in product development, safety assessment, and public health and representatives from collaborating agencies (Annex). Reviews of key issues were commissioned prior to the meeting and are summarised in this report. The meeting also considered the submitted manuscripts from recently completed studies directly relevant to the safety and effectiveness of N-9. This report summarises the evidence presented to the meeting on the safety of N-9 and its effectiveness for protection against pregnancy, sexually transmitted infections (STIs) and HIV. The meeting concluded with recommendations on the use of N-9 and identified key areas of uncertainty where more research was urgently required. (excerpt)
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  2. 2

    [Do not confuse spermicide and microbicide: a warning from WHO] Ne pas confondre spermicide et microbicide: une mise en garde de l'OMS.

    Equilibres et Populations. 2002 Jun-Jul; (78):[1] p..

    Although laboratory tests conducted during the 1970s and 1980s demonstrated nonoxynol-9's capacity to inactivate agents responsible for gonorrhea, chlamydia, and other STDs, including HIV, clinical trials delivered opposing conclusions. This article notes recent WHO findings that nonoxynol-9-containing spermicides increase the risk of HIV infection, gonorrhea, and chlamydia among women who use them often; research should be redoubled to develop effective microbicides against STDs; and systematic condom use currently remains the best way to prevent unwanted pregnancy and STDs, including HIV/AIDS.
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  3. 3

    IPPF European Network subsidiary company Enet withdraws nonoxynol-9 condoms.

    International Planned Parenthood Federation [IPPF]

    [London, England], IPPF, 2002 Oct 2. [1] p.

    This news article reports the approval of the International Planned Parenthood Federation European Network subsidiary company Enet on withdrawal of the Nonoxynol-9 lubricated variant from its range of condoms.
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  4. 4

    Vaginal rings releasing spermicides.

    World Health Organization [WHO]. Special Programme of Research, Development and Research Training in Human Reproduction. Task Force on Vaginal and Intracervical Devices for Fertility Regulation

    In: Zatuchni GI, Sobrero AJ, Speidel JJ, Sciarra JJ eds. Vaginal contraception: new developments. New York, Harper and Row, 1979. 188-93. (PARFR Series on Fertility Regulation)

    In response to the objectives of WHO for developing a reliable vaginal ring without systemic effects, a ring allowing for a constant release of spermicide Nonoxynol 9 was manufactured. Subsequently, it was clinically tested to assess sperm immobilization properties of Nonoxynol 9. Sterilized women with regular menses, active sex life and no evidence of vaginitis or infective cervicites were recruited in Japan and Mexico. 1 month prior to insertion the condition of the vagina was recorded and postcoital aliquots of venous blood and cervical mucus were used as baseline data. The vaginal ring was inserted on day 7 of the succeeding menstrual cycle and worn continuously for 10 days. Tests were made for sperm motility, estimation of Nonoxynol 9 levels in cervical mucus and plasma levels of Nonoxynol 9. 39 postcoital tests from 11 subjects showed a decrease in the number of motile sperm in cervical mucus. Nevertheless, some motile sperm still remained suggesting at the level of release of Nonoxynol 9, a contraceptive effect by sperm immobilization cannot be ensured. No side effects were evident.
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  5. 5

    Study of side-effects of vaginal microbicide.


    In January 1994, a clinical trial was launched in Amsterdam, Antwerp, and Bangkok to study the side effects of 2 weeks of daily use of Nonoxynol-9. A total of 300 women will be examined for scars and other damage caused by the Nonoxynol to the vaginal linings. Nonoxynol is known to kill sperm, and it was found to kill HIV in vitro in 1985. The World Health Organization (WHO) intends to develop Nonoxynol as a vaginal microbicide for women's protection against infection with HIV during vaginal penetration. The WHO has charged three university hospitals with the study of the effects to the vagina of a daily dose of 50mc to ascertain if Nonoxynol is worth developing as a microbicide. In the Netherlands, nonpregnant women aged 18-45 were solicited to participate. They were told to continue using their regular contraceptive. However, nobody mentioned the possibility that these women could be at risk of contracting HIV, as only one of them claimed to use condoms consistently. Questions remain unanswered as to the use and development of vaginal microbicides. The method is meant to increase women's autonomy in the prevention of HIV infection and empower them regarding their sexuality. It is doubtful whether the method's availability, cost, and resistance to heat and humidity have been considered. The WHO insists the vaginal microbicides are not meant to replace condoms, but it is certain at this moment that women are again targeted in the battle against the spread of AIDS.
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  6. 6
    Peer Reviewed

    Boost for vaginal microbicides against HIV.

    Lange JM; Karam M; Piot P

    Lancet. 1993 Nov 27; 342(8883):1356.

    In November 1993, WHO and the UK Department of Health cosponsored a meeting at which the participants addressed the need for women-controlled methods of preventing HIV infection. They called for animal studies to develop vaginal microbicides active against HIV which, in an ideal situation, the women could use without their sexual partners' knowledge. Ideally, any new product would also prevent transmission of other sexually transmitted diseases (STDs). They did caution, however, that the use of such microbicides should not replace, but complement other methods to prevent sexual transmission of HIV. They recommended also that appropriate clinical trials testing the safety and efficacy of the product should also take place. Participants called for WHO to develop the prototype protocols for phase I-III trials of vaginal microbicides. Some spermicides (nonionic detergents or surfactants) provide protection against some STDs (gonorrhea and chlamydial infections) and, in vitro, destroy HIV. Yet, they tend to irritate vaginal mucosa, facilitating HIV transmission. The likelihood of vaginal irritation increases with frequency of use and with doses. Women may not have symptoms indicating that they have spermicide-induced mucosal lesions. A study in Nairobi suggests that use of a sponge impregnated with high dose nonoxynol-9 increased the probability of HIV seroconversion. Lower doses of nonoxynol-9 had a protective effect against HIV seroconversion in studies in Cameroon and Zambia. In all these studies, however, there were sizable methodological limitations. The risk/benefit ratio for individuals using low to moderate doses of spermicides is not clear. Another consideration in that prevention of STDs, significant risk factors for HIV transmission, would reduce the spread of HIV.
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  7. 7

    Intravaginal and intracervical devices for the delivery of fertility regulating agents.


    JOURNAL OF STEROID BIOCHEMISTRY. 1979 Jul; 11(1B):461-7.

    This report succinctly summarizes Phase I and II clinical trials of intravaginal and intracervical delivery systems for fertility control agents (both steroidal and spermicidal) performed at World Health Organization (WHO) Centres internationally. The WHO Special Programme has conceived of and developed a number of vaginal rings (silastic), which are capable of achieving constant release rates of progestogenic steroid for periods of 90 or more continuous days of use. The local administration rules out the possibility of systemic side effects while the constant release is capable of inhibiting sperm migration through the cervical mucus efficacy of these devices incorporating norethisterone, levonorgestrel, and progesterone is in progress. The vaginal ring has also been incorporated with nonoxynol-9, a potent spermicidal agent. Constant daily release of this spermicidal agent also inhibits sperm migration in the cervical mucus, and use-effectiveness studies are underway. An inert intracervical device, designed and manufactured by WHO, is described (figures depict its manufacturer), and though it is suitable for constant release contraception, no such studies have been performed as yet. Numerous tables report particular release rate data for the vaginal rings impregnated with various dosages of progestogen or spermicide.
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  8. 8

    Jost intra-vaginal-device: a spermicidal sponge.


    [Unpublished] 1979. Presented at the Program for Applied Research on Fertility Regulation and Asociacion Pro-bienestar de la Familia de Guatemala International Workshop on New Devleopments in vaginal Contraception. Guatemala City, Guatemala, April 25-27, 1979. 9 p.

    The Jost intravaginal device (IVD) incorporates nonoxynol into a resilient, open-and-closed-cell polyurethane plug and is designed primarily as a spermicidal contraceptive with secondary action as a barrier to the cervical os. The IVD is applied via an applicator high into the vaginal canal where it expands and conforms to the shape of the vaginal vault. The spermicide is released during coital thrusts as a foam. In vivo spermicidal screening tests in macaque monkeys showed that in a group of 6 monkeys mated 24 hours after IVD insertion 5 aspirated vaginal specimens were free of motile sperm; however, 6 monkeys mated after 10 minutes of IVD insertion showed 17% motile sperm in aspirates. Phase 1 use-effectiveness studies are underway in Sweden; preliminary data on 200 women using the device for 7 months indicate high acceptability. Phase 2 will be carried out in planned parenthood clinics in the United States, using 200 volunteers who were previously sterilized. Retention times will vary from 24-72 hours. Another study must be designed to determine in vivo spermicidal efficacy.
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  9. 9

    Summary of World Health Organization Program.


    In: Gabelnick, H.L., ed. Drug delivery systems. (Proceedings of a Workshop sponsored by Contraceptive Development Branch, Center for Population Research, National Institute of Child Health and Human Development, Bethesda, Maryland, August 2-3, 1976) Bethesda, Maryland, U.S. Department of Health, Education, and Welfare, 1977. 339-413. (NIH 77-1238)

    The main drug delivery systems in which WHO is conducting research are for vaginal, cervical, uterine, nasal, and systemic delivery; these are summarized. For vaginal drug delivery, rings with progestational steroid have been developed but lack patient acceptability. In addition to progesterone (d-norgestrel and norethisterone are also being studied), spermicidal agents, specifically nonoxynol, are being tested in vaginal rings. For cervical drug delivery, studies of a cervical device with 2 prongs and a reservoir are underway using spermicidal agents rather than progestational steroids. Clinical acceptance studies underway indicate no problem with the inert device. Variable expulsion rates do pose a problem, hopefully one which can be resolved through better insertion techniques. Nonoxynol is a pH-dependent agent, so quinine is now being tested for efficacy because it is not pH dependent. A local histological study of the cervix will follow clinical trials. IUDs designed for developing countries are of interest to WHO, and to this end an IUD which is coated with some kind of rapidly degrading polymer, causing the device to shrink, would allow for postabortion and postpartum insertion. The problems of IUD acceptability and continuation rate in developing countries are being studied, and hopefully collaborative work will overcome pain and bleeding side effects. A systemic delivery system (study initiated 3.5 years ago) is designed to deliver drugs at a zero-order rate but problems with biodegradable material and inhibitory levels of progestational agents remain to be worked out.
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