Contraceptive Technology Update
(April 2002)

Each year, the authors of Contraceptive Technology conduct two contraceptive technology updates in the United States. In addition to the Contraceptive Technology authors (Willard Cates, Felicia Guest, Robert Hatcher, Deborah Kowal, Anita Nelson, Felicia Stewart and James Trussell), key reproductive health practitioners from throughout the United States serve as faculty. Designed to meet the needs of all types of healthcare providers, topics include new contraceptive methods, sexually transmitted diseases (STDs), gynecologic cancers, the changing reproductive health needs of clients as they move through the reproductive years, skill labs and case studies in managing gynecological, contraceptive and adolescent challenges. Although the conference in focused primarily on providing reproductive
health services in the United States, much of the information is also interesting and useful to an international audience.

This year, several members of JHPIEGO's Clinical Services Division were able to attend the update, held in Washington, D.C. from 14﷓16 March 2002. Over the next several months, they will share summaries of the sessions in which they participated. Although time and space constraints will limit the amount of detail, these summaries will focus on what is new and relevant internationally.

New Progestational Agent For Oral Contraceptive Pills

Drospirenone (DRSP) is a new progestational agent currently being used for combined oral contraceptive pills. Drospirenone is an analogue of spironolactone, an
aldosterone antagonist. It has high binding affinity for the mineralocorticoid receptor and has been shown to have antimineralocorticoid activity which influences the regulation of water and electrolyte balance in the body. In addition, like progesterone and spironolactone, DRSP also exhibits antiandrogenic activity.

Drospirenone was developed to provide an alternative for women who sometimes experience adverse effects with current oral contraceptives--principally, thrombosis, hypertension, weight gain, breast pain and acne. Like progesterone (but unlike other synthetic progestogens), drospirenone promotes the excretion of sodium and water, and therefore may reduce water retention symptoms. In addition, because it is antiandrogenic, it may help prevent users from developing acne. When bleeding irregularities with use of a combined drospirenone and ethinyl estradiol (EE) pill was compared to irregularities while using a desogestrel/EE pill, drospirenone/EE resulted in few irregularities overall, and less spotting and breakthrough bleeding in particular.

The USFDA has now approved Yasmin--a monophasic combined oral contraceptive pill containing 3 mg. of Drospirenone (DRSP) and 30 micrograms of Ethinyl Estradiol; it is manufactured by Berlex Laboratories. Yasmin has been
available in European countries since November 2000. Since Yasmin contains drospirenone, which may result in serious hyperkalemia in high-risk patients, the FDA safety labeling requires a bolded warning on the package insert to this effect. Thus, women having kidney, liver or adrenal disease should not use drospirenone-containing pills. Women taking NSAID (nonsteroidal antiinflammatory drug), spironolactone diuretics, ACE (Acetyl Choline Esterase) inhibitors, Angiotensin-II receptor antagonists and heparin also should not use pills containing drospirenone.

New Vaginal Hormonal Contraceptive Ring

Nuvaring(tm) is a new hormonal contraceptive available in the form of a non-biodegradable, transparent, and almost colorless vaginal ring releasing 120 micrograms of etonogestrel (3 keto desogestrel) and 15 micrograms of ethinyl estradiol each day. The outer diameter of the ring is 54 mm and cross section diameter is 4 mm. The vaginal ring works mainly by preventing ovulation. One ring is inserted into the vagina between day 1 and 5 of the menstrual cycle and left in for three weeks, followed by one ring-free week. A new ring is inserted at the end of the ring-free week. The USFDA approved the use of Nuvaring(tm) in October 2001. This vaginal hormonal contraceptive ring is now available in the United States, Canada and many European countries.

Use of the vaginal route as compared to an oral route for hormone delivery helps avoid hepatic first-pass metabolism and gastrointestinal interference with absorption, requires a lower dose than that given with oral formulations, ensures a controlled release of hormones, and does not require daily action. A constant serum concentration of hormones, a predictable bleeding pattern with exceptional cycle control (less breakthrough bleeding than OCs), a rapid return of ovulation, and the woman's being able to insert and remove the ring on her own are added advantages of the vaginal ring.

The vaginal ring is highly effective if used correctly and consistently. With perfect use, the reported pregnancy rate was 0.65. Perfect use is defined as inserting a ring during first five days of the menstrual cycle, keeping it in place for three weeks continuously followed by one ring-free week and then using a new ring starting from the first day following the ring-free week. If the ring is removed for any reason during the first three weeks, it should be inserted again within three hours. If more than three hours have elapsed since removing the ring, a backup method should be used for seven days from when the ring is reinserted.

Most side effects, precautions and complications are similar to oral contraceptive pills but are far less in severity and number. Foreign body sensation, intercourse problems and spontaneous expulsion are device-related problems.

Next month, look for an update on Emergency Contraception.

For additional information on any of these topics, contact
Lois Schaefer at lschaefer@jhpiego.org. 

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