OBJECTIVE: To explore the clinical efficacy and safety of MYCu intrauterine contraceptive device (IUD) containing indomethacin. METHODS:From October 1 to December 31, 2004, women of child-bearing age requiring IUD for contraception were chosen from the Outpatient Departments of China-Japan Friendship Hospital of Jilin University, Peking University First Hospital, Peking University Third Hospital, Jilin University Second Hospital and Affiliated Shengjing Hospital of China Medical University. They were randomly inserted with MYCuIUD and control TCu380A IUD each for 1000 cases and followed up at 1, 3, 6, 12, 24, 36, 48 and 60 months post-insertion. RESULTS: When MYCu IUD group and TCu380A group 60 months post-insertion were compared, the cumulative pregnancy rates with IUD in situ were 2.38/100 women per year and 2.84/100 women per year respectively. And the difference had no statistical significance (P > 0.05); the cumulative expulsion rates, mostly of partial expulsion and downward movement, were 0.87/100 women per year and 2.94/100 women per year respectively. And the difference had statistical significance (P < 0.05); the cumulative termination rates due to bleeding/pain were 3.57/100 women per year and 4.83/100 women per year respectively. And the difference had no statistical significance (P > 0.05); Side effects in MYCu group were less pronounced than those in TCu group. And the inter-group differences had statistical significance (P < 0.05). CONCLUSION: As a comparatively ideal medicated medical device, MYCu IUD has an excellent contraceptive efficacy, a low rate of expulsion and side effects and good reversibility. Particularly a low occurrence rate of bleeding and pain during early insertion is recommended. Its life expectancy is 15 years. And its contraceptive effectiveness and safety after 5 years should be examined during further follow-ups.
RCT Entities:
OBJECTIVE: To explore the clinical efficacy and safety of MYCu intrauterine contraceptive device (IUD) containing indomethacin. METHODS: From October 1 to December 31, 2004, women of child-bearing age requiring IUD for contraception were chosen from the Outpatient Departments of China-Japan Friendship Hospital of Jilin University, Peking University First Hospital, Peking University Third Hospital, Jilin University Second Hospital and Affiliated Shengjing Hospital of China Medical University. They were randomly inserted with MYCuIUD and control TCu380A IUD each for 1000 cases and followed up at 1, 3, 6, 12, 24, 36, 48 and 60 months post-insertion. RESULTS: When MYCu IUD group and TCu380A group 60 months post-insertion were compared, the cumulative pregnancy rates with IUD in situ were 2.38/100 women per year and 2.84/100 women per year respectively. And the difference had no statistical significance (P > 0.05); the cumulative expulsion rates, mostly of partial expulsion and downward movement, were 0.87/100 women per year and 2.94/100 women per year respectively. And the difference had statistical significance (P < 0.05); the cumulative termination rates due to bleeding/pain were 3.57/100 women per year and 4.83/100 women per year respectively. And the difference had no statistical significance (P > 0.05); Side effects in MYCu group were less pronounced than those in TCu group. And the inter-group differences had statistical significance (P < 0.05). CONCLUSION: As a comparatively ideal medicated medical device, MYCu IUD has an excellent contraceptive efficacy, a low rate of expulsion and side effects and good reversibility. Particularly a low occurrence rate of bleeding and pain during early insertion is recommended. Its life expectancy is 15 years. And its contraceptive effectiveness and safety after 5 years should be examined during further follow-ups.