Gynecology, Obstetrics and Women Health

Copper Intra uterine devices represent an important contraceptive option for nearly 160 million women worldwide. The main attraction of copper Intra Uterine Device (IUD) is that it is comparatively less expensive and highly effective (99%) over other long term methods of contraception. Major side effect related to a copper bearing IUD is increased menstrual bleeding, cramping and abdominal pain. Rates of removal of copper IUD because of bleeding and pain ranges from 1 to 17 per 100 women. Research results showed that this is due to the high corrosive rate of copper during the first few months of insertion. The present study reports the modification of an existing Intra Uterine Device (IUD) with a FDA approved polymer, poly lactic acid and poly(lactic/glycolic) acid (PLGA) to control the release of active ingredient. The side effects associated with the uncontrolled release of the active ingredient is controlled effectively by providing a safe coating of PLGA over the device which in turn increase the world wide acceptance of the device. A Phase-II, multicenter, randomized, single-blind, parallel-arm, pilot scale trial was conducted in 200 women over a period of 12 months across 10 sites in India to detect the clinical performance of coated Copper T (CCT) versus conventional Copper T(OCT) for initial bleeding and pain, post insertion of IUD. This was done using a standardized PBAC scoring system on the PBAC chart. CCT has shown promising result in our study and reduced the menstrual blood loss significantly. The study validates our hypothesis that modulation of copper release from a copper IUD using a biodegradable membrane can decrease the side effects of CCT like increased menstrual bleeding without contraceptive efficacy