OBJECTIVE

To assess the efficacy, safety of Norplant implants used by Chinese women.

METHODS

In a prospective, multicenter clinical trial, 10,718 women receiving Norplant implants were monitored annually through 5 years and part of women continuously used the implants up to 7 years.

RESULTS

The five-year pregnancy rate was 0.63/100 users. 7,554 women completed 5 years, 3,622 women completed 6 years and 2,433 women completed 7 years. The annual pregnancy rates were 0.40/100 users in both year 6 and year 7. The pregnancy rates increased with weight (P < 0.05) and decreased with age. The menstrual disturbances were common, also the main reason for discontinuation. Headache, dizziness and weight gain led to termination more frequently than did other adverse events apart from menstrual disturbances. The 5-year continuation rate was 72.1/100 users. Among aged>> 30 and weight < 60 kg, the implants may be used for 7 years.

CONCLUSIONS

It's proved that the Norplant implants is a highly effective, long acting, safe, simple and reversible contraceptive method, and it is acceptable in Chinese women.