International Study: Norplant -- May 7, 2003

Research Triangle Park, NC -- If you ask a group of former Norplant users why they stopped using this very safe and effective hormonal contraceptive, many who stopped early will tell you that it was because of menstrual problems. In a new study, researchers probed further and now describe in detail the specific menstrual difficulties associated with risk of early Norplant removal.

An analysis of more than 3,400 Norplant users from 11 countries in Asia, Africa, and Latin America shows that users who menstruate for more than a week, bleed for more than a week between menstrual periods, or bleed excessively during menstruation are up two times more likely than other women to stop using the contraceptive early because of menstrual problems. Women who experience menstrual cramps are also at slightly higher risk of early discontinuation.

This research has important implications for counseling women who use Norplant, says lead author Dr. Roberto Rivera of Family Health International, where the research was conducted. "If health care providers know what these particular menstrual disturbances are, then they can address them when counseling a woman who is starting to use Norplant," he says. "And when they occur in a woman who is already using Norplant, they should be a sign to providers that the woman is at risk of discontinuing use."

Menstrual disturbances are the most common side effect of Norplant, but they tend to decrease during the first few months of use. Nevertheless, the four menstrual disturbances that increased risk of discontinuation in the study persisted one, two, and even three years into the research.

"This shows that these disturbances are important reasons for discontinuation any time they occur," says Dr. Rivera. "Some people say women get used to menstrual disturbances over time, but that does not seem to be the case."

Norplant, which is implanted under the skin of a woman's upper arm to prevent pregnancy, is composed of six capsules that release daily doses of levonorgestrel, a form of the hormone progestin. The implantable contraceptive is more than 99 percent effective and can be used for up to seven years without having to be removed. It is available in more than 60 countries, including the United States.

The study, reported in the May 2003 issue of the journal Contraception, included a subset of women who were involved in larger trials to establish the safety, effectiveness, and acceptability of Norplant before it was introduced worldwide in the 1980s. Researchers compared menstrual characteristics of 2,667 women who used Norplant for three years with those of 752 women who discontinued use because of menstrual problems during the same three-year period. Characteristics that were tested but not associated with early Norplant removal were length of a woman's menstrual cycle, the presence of bleeding between menstrual periods for less than a week, and pelvic pain between periods.

The results of this study are likely applicable to other implantable contraceptives as well, says Dr. Rivera. "It is reasonable to anticipate that when similar menstrual problems occur in women using other kinds of implants, the concerns of the users, and thus the risks of early discontinuation, will be the same," he notes. "Counseling continues to be the main tool in the management of these problems."

For more information on how menstrual disturbances influence contraceptive use, see Network Vol. 19, #1.

Source

Rivera R, Rountree W. Characteristics of menstrual problems associated with Norplant discontinuation: results of a multinational study. Contraception 2003;67(5):373-77.

Family Health International is dedicated to improving lives, knowledge, and understanding worldwide through a highly diversified program of research, education, and services in family health and HIV/AIDS prevention and care. Since our inception in 1971, FHI has formed partnerships with national governments and local communities in countries throughout the developing world to support lasting improvements in the health of individuals and the effectiveness of entire health care systems.