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Advances in Reproductive Health Advances in Reproductive Health include changes in and/or new products available to us in the United States. The advances identified in this edition of the ReCAPP web site are representative but not exhaustive. Exciting advances in reproductive health are emerging almost daily, and the advances covered here should remind us to stay tuned for future developments in this dynamic field. This edition
of Topic in Brief includes the following:
Some of the recent developments in the field of reproductive health are listed below. Wherever possible, we note references for further information on these advances. Nonoxynol-9 (N-9) is a spermicide which has been used in contraceptive foams, gels, and lubricants and on condoms, to prevent sexually transmitted infections (STIs), as well as pregnancy. However, important new information emerged during the International AIDS Conference last year (July 2000) concerning results from a study on HIV prevention in women. The study found that N-9 can cause irritation in some people and may, ironically, put users at greater risk for certain STIs including HIV. Many national organizations, including the Centers for Disease Control and Prevention (CDC), have reversed their earlier recommendations to use N-9 for HIV prevention. While the jury is still out on the risks and benefits of N-9, many sexuality educators simply advise consumers to always use condoms correctly and consistently. For more
information, see the CDC webpage: www.cdc.gov/hiv/pubs/mmwr/mmwr11aug00.htm
Injectables Lunelle is injected more often, once a month, compared to Depo Provera, injected once every three months. Lunelle contains both estrogen and progestin whereas Depo Provera contains only synthetic progesterone. The added estrogen in Lunelle mimics a more natural hormonal mix, so Lunelle usually helps to maintain regular menstrual periods, while Depo Provera can cause very irregular cycles, or no bleeding at all. Finally, women who use Lunelle return to fertility relatively quickly, usually within two to four months; Depo Provera can take from six months to two years. As with contraceptives taken orally, Lunelle can cause side effects such as breast tenderness, acne, weight gain or loss, and/or mood swings. Also, like all hormonal contraceptives – both oral and injected – Lunelle will not protect against STIs. See the
following web sites for more information on Lunelle: The Female Condom is a safe, effective barrier method for preventing pregnancy and STIs, including HIV/AIDS. It is a lubricated polyurethane sheath shaped like the male condom, but has flexible rings at each end. The closed end is inserted into the vagina, while the open end remains outside, partially covering the woman's labia. Like the male condom, the female condom is available without a prescription and is intended for one-time use. Although it takes more practice to use than the male condom, the female condom provides women with more control in protecting themselves. For more information on the female condom, check out the web site: http://www.femalecondom.org and ReCAPP's February 2001 Topic in Brief Male Contraception (Pills, Shots, and Implants) is gaining worldwide support according to recent studies. Last year's European journal Human Reproduction showed that 80% of women favored male contraception, and 66% of men said they would use a pill. (Source: Popline, March-April 2000 as reported in the Religious Consultation Report, Nov. 2000, Volume 4 No. 2.) Unfortunately, despite the need and public interest, options for male contraception are still limited to the traditional methods – condoms, vasectomy, withdrawal and abstinence. While several innovations are being studied, it may take another 5-10 more years before new options become widely available. Researchers are studying a variety of approaches to male contraception. Scientists in England and Scotland have found a combination of synthetic hormones that stop sperm production without affecting a man's sex drive. A small pellet of testosterone is implanted into the man's abdomen every 12 weeks. This approach keeps libido active and also avoids unpopular testosterone shots. However, this implant must be combined with a daily progesterone pill which stops sperm production entirely in two to three months. Additional studies are being conducted in which both hormones may be implanted in the body, eliminating the need for a daily pill. Scientists in the U.S. are looking into male contraceptives that do not rely on hormones. Some are studying ways to block the chemicals which enable sperm to reach the egg. Still other scientists are developing compounds that prevent the sperm cells from maturing without affecting their production. However, neither of these approaches has yet been tested on human subjects. The challenge in the search for an effective male contraceptive pill is due, partly, to the complicated nature of the male reproductive system. In a woman, only one ovum at a time must be targeted for pregnancy prevention efforts; in a man, millions of sperm need to be blocked or eliminated. For more
information on advances in male contraception, check out the following
sources: Vaginal
Microbicides are products currently in development to prevent
the spread of a variety of sexually transmitted infections (STIs). While
not yet available, vaginal microbicides would protect a woman from STIs
in one or more of the following ways:
Scientists are trying to develop microbicides that will prevent STIs while keeping toxicity levels low enough to avoid vaginal irritation with repeated use. Experiments are underway with at least 60 vaginal microbicides in various forms including gels, creams, suppositories, film, sponges, and vaginal rings. Some microbicides are being developed to prevent pregnancy as well as STIs. In addition, non-contraceptive microbicides are being explored for women who have HIV-positive partners and want to have children. For more
information on microbicides, check out: Vaccines for Sexually Transmitted Infections (STIs) are being researched here and abroad. However, the hepatitis B vaccine is the only one currently available in this country. Hepatitis B is a prevalent STI in the U.S., but many people are still unaware that it can be transmitted sexually. It's estimated that over one-half million people have sexually transmitted hepatitis B. Hepatitis B vaccination is now routine for health workers, children, and young adolescents. Vaccination consists of three shots. The first injection is followed by a second injection one month later, and the third injection is given six months after the second. Testing is now underway for vaccines to prevent HIV, HSV-2 (genital herpes simplex virus), and HPV (human papilloma virus, or "warts"). Since, in general, STIs tend to be a sensitive topic, gaining popular support for the vaccines can be more difficult than for other types of infectious diseases. Also, vaccination should not be viewed as a replacement for responsible sexual behavior. To read more about public attitudes towards vaccination, see ReCAPP's Research Summary "College Students' Attitudes Regarding Vaccination to Prevent Genital Herpes." Further
information can be obtained from the following web sites: www.vaccines.ashastd.org/answers.html#20
or Human Papilloma Virus (HPV) Testing & Vaccination are advances which show promise of decreasing the number of women who develop cervical cancer. HPV, the virus associated with abnormal cervical tissue changes and cervical cancer, infects more than five million people a year, making it the most common STI in the U.S. Some researchers have found HPV prevalence for women under age 25 to be somewhere between 28% and 46%. Conventional testing for abnormal or precancerous cells in the cervix (most likely caused by HPV) is the Pap Smear. Now there is a test called ThinPrep® which, in the four years since it was approved by the FDA, has gained 36% of the U.S. market. Fifty independent studies have shown ThinPrep to be more accurate than the conventional Pap test in detecting abnormal and precancerous cells. In December 2000, the American College of Obstetrics and Gynecology (ACOG) withdrew its official 1998 opinion that the Pap test was the "gold standard" for cervical cancer screening. While far from an official endorsement, this change of position should help to make the ThinPrep test more readily available. In fact, Cytyc Corporation, the developer of the ThinPrep test, hopes that within the next two years, ThinPrep will be the "standard of care." In addition to ThinPrep, research in human subjects is currently underway to develop vaccines for several variations of several types of HPV. (There are about 70 types of HPV, but only a few types associated with cervical cancer.) The protocol for an HPV vaccine is first immunization of girls at about 10 years of age, before they become sexually active, and then a booster in the late teens. Further
information about HPV testing and vaccines can be found in the following
source: Oral Contraceptives (the pill) for purposes other than birth control is an advance gaining more support over the past several years. Physicians have begun prescribing the pill to women for reasons unrelated to birth control. For example, the Food and Drug Administration (FDA) has approved the pill Ortho Tri-Cyclen for the prevention of acne. Researchers have found that the pill can regulate hormones and help to prevent or lessen acne, premenstrual syndrome (PMS), and pain associated with endometriosis, ovarian cysts or fibroids. Physicians have started prescribing the pill to some patients for up to four cycles in a row to prevent pain associated with these conditions as well as clotting deficiencies, facial hair growth, and many of the symptoms associated with PMS such as migraine headaches, bloating, breast tenderness, cramps, and mood swings. In addition, the pill may reduce the chances of a woman developing ovarian cancer. Woman who take the pill for at least one year have been shown to have a reduced risk of ovarian cancer, and for each additional year until the fifth year, the pill continues to decrease the risk of ovarian cancer up to 50%. Check out
the following sources for further information on medical benefits of oral
contraceptives: Natural Family Planning (NFP) is an age-old practice that is currently receiving more attention and approval. NFP is a birth control practice which involves heightened awareness of the signals and patterns of a woman’s menstrual cycle. NFP can be used to avoid or postpone pregnancy, or conversely, to increase the odds of becoming pregnant. There are three basic methods used in NFP. A woman may use the methods separately or in combination. The more methods used, however, the more accurate ovulation can be predicted. The first method, and maybe the oldest, is the calendar method, which is based on ovulation occurring at a set number of days before a woman's next period. The second method is charting the woman's basal body temperature, which should be taken first thing in the morning before arising from bed. The third method involves charting the woman's vaginal secretions, which change in texture and color throughout her menstrual cycle. New technology in the form of ovulation kits, which measure a hormone called "luteinizing hormone," can fairly accurately predict the time of ovulation for a woman. Unipath Labs is also developing a kit which uses metabolites from a woman's urine to identify her most fertile timeframe. For more
information on NFP, check out these web sites: Plan B and Preven are two emergency contraceptive pill products (also called "dedicated products") currently available to women with a doctor's prescription. While the ingredients in these products differ, both Plan B and Preven should be taken within 72 hours of unprotected intercourse. The sooner that emergency contraception is started, the more effectively it prevents pregnancy. While both products are considered safe and will not harm a developing fetus, neither product should be used as a routine form of birth control, since other forms of contraception are more effective and can provide protection from sexually transmitted infections (STIs). Preven, which appeared on the market in 1997, is a kit containing four pills (which combine estrogen and progestin) and a pregnancy test. Users may experience some side effects when using this contraceptive, including nausea and vomiting. Plan B, more recently approved by the FDA, is a package with only two pills which contain progestin only. Plan B is more effective and may cause fewer side effects for users than Preven since it does not contain estrogen. Further
information on these emergency contraceptive pill products can be found
at Planned Parenthood's web site: Over-the-counter (OTC) Availability of Emergency Contraception Pills (ECPs) is also on the horizon. The change from prescription-only to over-the-counter availability of any drug must first be approved by the FDA. Traditionally, this change is requested by the manufacturer of the drug, but the request can also be made by the FDA itself or by the general public in the form of a citizen petition. While many medical experts, including the American Medical Association, support OTC availability of ECPs, there are several important questions being considered in the debate, such as:
Check out
the following web sites for more information on the debate about ECPs'
availability over-the-counter: Medical Abortion is a term that describes the use of a combination of drugs, or "abortifacients," to terminate a pregnancy. Medical abortion differs from surgical abortion (such as vacuum aspiration, or dilation and evacuation), and from spontaneous abortion, also known as a miscarriage. The most common drugs currently used for medical abortion are:
The combination of mifepristone and misoprostol has been found effective in terminating early pregnancies (up to about 65 days). Medical abortion can be performed earlier in the pregnancy than surgical abortion and is also less invasive. Potential drawbacks include the need for at least two office visits, potential prolonged bleeding, and a slightly higher failure rate than surgical abortion, which can require follow-up by a surgical method. The approval of these drugs for use as abortifacients provides more options for women wanting an early termination of pregnancy and may increase the number of physicians who provide early abortion services. Further
information on medical abortion is available from the Journal of the American
Medical Women's Association: Premenstrual Dysphoric Disorder (PMDD) is a severe form of premenstrual syndrome (PMS). Both PMDD and PMS occur the week before the onset of menstruation and can last the length of menstruation. PMDD and PMS share many of the same symptoms, including breast tenderness, bloating, irritability and mood swings. However, PMDD has much more severe emotional symptoms, including severe mood swings, depressed mood, feelings of hopelessness, anxiety, sleep disturbances, difficulty concentrating, and angry outbursts. PMDD interferes with a woman's everyday life and can greatly affect her relationships with family and friends. Since symptoms of PMDD may impair social functioning, and in extreme cases, lead women to become suicidal or homicidal, it has recently received an official psychiatric diagnosis. Managing overall health through lifestyle choices can reduce symptoms of PMS and PMDD in many women. The following healthy practices are therefore recommended:
Medical treatments are also available for women with PMS or PMDD. PMS is generally treated with birth control pills and other medicines to address the symptoms of breast tenderness, bloating and weight gain, menstrual pain and cramping. PMDD, however, can also be treated with anti-depressants, including selective serotonin reuptake inhibitors (SSRIs) such as Prozac, Effexor or Zoloft. For more information on PMDD and PMS, check out the following web site: http://www.drdonnica.com/display.asp?article=1086 Still
to Come: Intrauterine System, Single Rod Implant, Vaginal Ring, Contraceptive
Patch There are two long-acting progestin-only options on the horizon. One is called the Levonorgestrel Intrauterine System (LNG IUS). This is a highly effective, long-term intrauterine system that has resulted in a significant decrease in bleeding and has shown to be safer than IUDs. The other method is a single rod implant called the Implanon® Rod. Like the Norplant system – the most common rod implant – the Implanon rod is inserted under the skin in a woman's arm. It is effective up to three years. Since it is a single five-centimeter rod, as opposed to Norplant's six- and two-rod systems, it is significantly easier to insert and remove. The published data on two other methods – the vaginal ring and the contraceptive patch – is still limited. The vaginal ring is a small ring the size of a diaphragm that is self-inserted every four weeks. Unlike the rod implant and the LNG IUS, the vaginal ring releases doses of both progestin and estrogen. The contraceptive patch also releases both hormones. It is self-administered once a week and is worn three weeks out of four. As of December 2000, the vaginal ring has not been approved as a contraceptive device by the FDA. The contraceptive patch was submitted as a new drug to the FDA in January 2001.
Clearly, there is a growing demand for reproductive advances, and good research is being conducted to meet that demand. This means that those of us providing information and education on reproductive health must keep up on the latest news and reports from the field. Being a good reproductive health educator means being familiar with the issues and knowing where to get answers to questions we may be asked. Our students look to us as reliable resources for current information, so our credibility as teachers and mentors may be on the line. Obviously, we can't know everything, but at least knowing where to find the latest information should be part of our role as educators. Being able to find up-to-date information is particularly important in an area where technology and policy change rapidly.
Organizations and web sites with additional information on advances in reproductive health include:
Sexuality
Information and Education Council of U.S. (SIECUS) Alan
Guttmacher Institute (AGI) American
School Health Association (ASHA) Kaiser
Family Foundation American
Medical Women's Association Planned
Parenthood Federation of America Family
Health International American
Social Health Association Advocates
for Youth National
Campaign to Prevent Teen Pregnancy Home
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