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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:

Definitions

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
and/or the Alan Guttmacher Institute web site:
www.agi-usa.org/pubs/microbicides.html

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Injectables
Lunelle
is a contraceptive injection which was approved by the FDA in late 2000. It differs in several ways from Depo Provera, the other injected birth control option which has been available for many years.

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:
http://www.pharmacia.com/
http://www.jademagazine.com/10iss_lunelle.html

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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 ReCAPP Topic in Brief on condoms

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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:
http://www.healthsurfing.com/health/2000/04/04/
http://www.rti.org/news/bc_male_new.cfm
http://www.rti.org/news/bc_male_apnews.cfm

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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:

  1. creating a barrier between the STI germ (bacteria, virus, etc.) and the vaginal wall;

  2. killing or immobilizing the STI germ; and/or

  3. preventing a virus from multiplying once it has infected the vaginal wall.

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:
http://www.agi-usa.org/pubs/microbicides.html
.

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Vaccines for Sexually Transmitted Infections (STIs) are being researched here and abroad. Currently available in this country are the Hepatitis B vaccine and HPV vaccine.

Hepatitis B is a prevalent STI in the U.S., but many people are still unaware that it can be transmitted sexually, and it is estimated that over one-half million people have sexually transmitted hepatitis B. Hepatitis means inflammation of the liver. It can be caused by viruses, bacteria, parasites, autoimmune conditions, reactions to certain drugs, heavy alcohol use, and other toxins. Hepatitis also refers to a family of viral infections that affect the liver; the five identified infections are caused by viruses labeled A, B, C, D, and E. Each virus has different routes of transmission and different prognoses. The 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.

HPV (human papilloma virus, or "warts") is one of the most common causes of sexually transmitted infection (ST I) in the world. See Human Papilloma Virus (HPV) Testing & Vaccination below for more details.

Testing is now underway for vaccines to prevent HIV and HSV-2 (genital herpes simplex virus). 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:

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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 six 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.

Research on 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.) Two HPV vaccines, Gardasil and Cervarix, are now approved by the FDA. Both vaccines are highly effective in preventing persistent infection with HPV types 16 and 18, two "high-risk" HPVs that cause most (70 percent) of cervical cancers. Gardasil is also effective against types 6 and 11, which cause virtually all (90 percent) of genital warts.

Both vaccines are licensed, safe, and effective for females ages 9 through 26 years. The CDC recommends that all girls who are 11 or 12 years old get the 3 doses of either brand of HPV vaccine to protect against cervical cancer and pre-cancer. Gardasil is also licensed for boys and young men ages 9 through 26 years. Males may choose to get this vaccine to prevent genital warts.

Neither Gardasil nor Cervarix has been proven to provide complete protection against persistent infection with other HPV types, some of which also can cause cervical cancer. Therefore, about 30 percent of cervical cancers and 10 percent of genital warts will not be prevented by the current vaccines. HPV vaccines do not prevent other sexually transmitted infections, nor do they treat HPV infection or cervical cancer.

Further information about HPV testing and vaccines can be found in the following sources:

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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:
http://spwomenshealth.com/healthtalk/pill_medcondition.html
http://my.webmd.com/content/article/1728.59714

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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:
www.familydoctor.org/handouts/126.html and
www.fhi.org/en/fp/fpfaq/fpfaqs/fpfaq7a.html

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Plan B® (2 pills) or Plan B One‑Step® (one pill), Next Choice® (generic brand) and ella® are the four emergency contraceptive pill (ECP) products (also called "dedicated products") currently available to women with a doctor's prescription. Plan B®, Plan B One‑Step® and Next Choice® are progestin-based, while ella® is a single-dose ulipristal acetate pill. Study findings show that side effects for ella are comparable to those for Plan B.

Pharmacists in all states are allowed to dispense Next Choice®, Plan B® or Plan B One‑Step® without prescription to women 17 and older. However, pharmacists in Maine, New Hampshire and Vermont are allowed to dispense Plan B® or Plan B One‑Step® without prescription to women of all ages, even under the age of 17. For youth under 17, a health care provider must be used to prescribe the correct dose of Emergency Contraceptive Pills (ECP) and explain how to use them.

Next Choice®, Plan B® or Plan B One‑Step® should be taken within 72 hours of unprotected intercourse, while ella® should be taken within 120 hours of unprotected intercourse. The sooner that emergency contraception is started, the more effectively it prevents pregnancy. While all of these products are considered safe and will not harm a developing fetus, they should be used as a routine form of birth control, since other forms of contraception are more effective and can also provide protection from sexually transmitted infections (STIs).

Further information on these emergency contraceptive pill products can be found at www.kff.org/womenshealth/3344.cfm

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Over-the-counter (OTC) Availability of Emergency Contraception Pills (ECPs): The change from prescription-only to over-the-counter availability of ECPs has been approved by the FDA. Now Plan B®, Plan B One‑Step® or Next Choice® (generic brand) can be purchased without prescription by anyone 17 years and older. Minors under 17 still require a prescription, unless they are purchasing the ECPs in Maine, New Hampshire or Vermont.

Check out the following web sites for more information about Ecs: ec.princeton.edu and www.kff.org/womenshealth/upload/3344-04.pdf

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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:

  1. Mifepristone (RU-486) was developed by the French in 1980. It blocks the action of progesterone, a hormone necessary to sustain an early pregnancy, and increases the uterus’ sensitivity to prostaglandins, which cause uterine contractions.

  2. Methotrexate is currently marketed in the U.S. (since 1954) for treatment of certain cancers and arthritis, and to terminate ectopic pregnancy (where the fetus develops outside the uterine cavity). It keeps the embryo from developing and implanting in the uterine wall.

  3. Misoprostol has been used in the U.S. to prevent gastrointestinal ulcers since 1988. It can also be used to cause uterine contractions, which can expel a fertilized egg from the uterus. This drug is currently used in combination with mifepristone when used for medical abortion.

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 Planned Parenthood Federation of America webpage: www.plannedparenthood.org/library/facts/medabort_fact.html.

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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:

  • Eat regular meals and a balanced diet low in meat, sugar and salt.

  • Stop smoking and reduce or eliminate alcohol and coffee consumption.

  • Reduce stress by adjusting expectations or employing stress reduction activities.

  • Get plenty of sleep.

  • Get aerobic exercise three or four times a week.

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

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Transdermal contraceptive patch ("the patch")
ORTHO EVRA® is the brand name of an adhesive patch that delivers pregnancy-preventing hormones through the skin. A woman wears each patch for one week at a time for three consecutive weeks. The fourth week is patch-free, which allows her to have her menstrual period. The patch does not offer protection from STIs.

Note: Hormones from ORTHO EVRA get into the blood stream and are processed by the body differently than hormones from birth control pills. Users will be exposed to about 60% more estrogen if they use ORTHO EVRAthan if they use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. In January 2008, the U.S. Food and Drug Administration (FDA) approved additional changes to the ORTHO EVRA label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE) than women using birth control pills. VTE can lead to pulmonary embolism. For more information on ORTHO EVRA, visit: www.orthoevra.com.

Vaginal ring
The NuvaRing® acts like a time-release capsule in the form of a ring. It is a flexible ring, two inches in diameter, which a woman folds and inserts in her vagina once a month. Once inserted, the ring slowly releases hormones (estrogen and progestin) for three weeks. Approved by the FDA at the end of 2001, this method contains hormones similar to those in birth control pills, so their advantages — and disadvantages — are similar. It does not offer protection from STIs.

Note: On August 22, 2008 the Judicial Panel on Multidistrict Litigation (JPMDL) granted a petition filed by plaintiffs in 11 NuvaRing federal court lawsuits seeking creation of a NuvaRing multidistrict litigation (MDL). Their claim is that NuvaRing use is associated with serious side effects resulting from blood clots, such pulmonary embolism (PE) and deep vein thrombosis (DVT) as well as strokes and heart attacks, with some events resulting in death. As of December 2010 there have been no Nuvaring lawsuit settlements, and cases continue to be filed by women. The first trials in federal court will not begin until the spring or summer of 2012.

For more information about the NuvaRing, visit the manufacturer's web site at: www.nuvaring.com.

Under-the-skin contraceptive implant
Implanon® is a thin, flexible plastic implant about the size of a cardboard matchstick. It is inserted under the skin of a woman’s upper arm and protects against pregnancy for up to three years. Implanon was approved by the FDA in 2006 for sale in the USA, and more and more health care providers are being trained to insert and remove this contraceptive method. (The former implants, Norplant and Jadelle, are no longer available in the USA.) Like several other methods of birth control, such as the birth control shot, Implanon releases a hormone — progestin. The progestin in Implanon works by keeping a woman's ovaries from releasing eggs, i.e., ovulating. Pregnancy cannot take place if there is no egg to join with sperm. The hormone in the implant also prevents pregnancy by thickening a woman's cervical mucus. The mucus blocks sperm and keeps it from joining with an egg. Implanon does not offer protection from STIs. For more information go to: www.plannedparenthood.org/health-topics/birth-control/birth-control-implant-implanon-4243.htm

Intrauterine systems (IUS)
An intrauterine system known as the Mirena IUS® is now available. Unlike the IUD, the IUS decreases monthly bleeding and cramping. Made of light plastic, the t-shaped Mirena works like many other types of intrauterine contraceptive systems. It is fitted by a health care professional and remains in the womb for up to five years. It gradually releases a very small amount of levonorgestrel (one of the hormones commonly found in the birth control pill) every day to prevent pregnancy and is more than 99% effective. In the Mirena, however, a much lower dose is released than when you take the Pill (about 1/7th strength) and it goes directly to the lining of the womb, rather than through the blood stream where it may lead to the common progesterone-type side effects. The IUS does not offer protection from STIs, and the IUS cannot be used for emergency contraception. For more information, visit: www.womens-health.co.uk/mirena.asp

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An Overview of the Issues

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.

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What Educators Can Do

  • Keep up with your professional journals. If you do not have enough time to read all the journal articles, copy the table of contents and keep subject files of articles available.

  • Make sure you're adequately plugged in to the internet. There are many available sources of information today, including internet listservs that provide current news and reports, some on a daily basis. One good example is Kaiser Family Foundation's Daily Reproductive Health Report (a free service), available at
    www.kaiserhealthnews.org/Headlines.aspx?utm_source=khn&utm_medium=internal&utm_campaign=nav-bar

  • Attend workshops and conferences for updates (e.g. Contraceptive Update is an annual conference conducted by the authors of the book, Contraceptive Technology), that help keep you "fresh."

  • Maintain a small in-house library and encourage colleagues to contribute or share their resources as a group.

  • Take responsibility to organize "think tanks" or "journal clubs" with peers and other health education program staff. Keep each other updated by summarizing reports or circulating interesting articles for review and group discussion.

  • Teach your students where to find the latest information on advances in reproductive health. For more information, see ReCAPP's Youth Skill: Advocating for Your Health Care.

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More Information/Resources

Organizations and web sites with additional information on advances in reproductive health include:

 

  • Sexuality Information and Education Council of U.S. (SIECUS)
    130 W. 42nd Street, Suite 350
    New York, NY 10036-7802
    (212) 819-9770
    www.siecus.org

  • Alan Guttmacher Institute (AGI)
    120 Wall Street
    New York, NY 10005
    (212) 248-1111
    www.agi-usa.org

  • American School Health Association (ASHA)
    7263 State Route 43
    P.O. Box 708
    Kent, Ohio 44240
    (330) 678-1601
    www.ashaweb.org

  • Kaiser Family Foundation
    2400 Sand Hill Road
    Menlo Park, CA 94025
    (650) 854-9400
    www.kff.org

  • American Medical Women's Association
    801 N. Fairfax Street
    Suite 400
    Alexandria, VA 22314
    (703) 838-0500
    www.amwa-doc.org

  • Planned Parenthood Federation of America
    810 Seventh Ave.
    New York, NY 10019
    (212) 541-7800
    www.plannedparenthood.org

  • Family Health International
    P.O. Box 13950
    Research Triangle Park, NC 27709
    (919) 544-7040
    www.FHI.org

  • American Social Health Association
    P.O. Box 13827
    Research Triangle Park, NC 27709
    (919) 361-8400
    www.ashastd.org

  • Advocates for Youth
    1025 Vermont Avenue NW
    Suite 200
    Washington, D.C. 20005
    (202) 347-5700
    www.AdvocatesforYouth.org

  • National Campaign to Prevent Teen Pregnancy
    1776 Massachusetts Avenue NW
    Suite 200
    Washington, D.C. 20036
    (202) 478-8500
    www.teenpregnancy.org