Evaluation of a progesterone vaginal ring as a new contraceptive option in India

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DESCRIPTION (provided by applicant): The lactational amenorrhea method (LAM) is recognized as an effective means of postponing the return to fertility in nursing mothers and spacing births, however in developing countries, urbanization has reduced the duration of breastfeeding and its effectiveness as a contraceptive method. The purpose of this project is to complete the development of a progesterone vaginal ring (PVR) that was shown to be effective in previous clinical studies to prolong LAM and for the spacing of pregnancies. However there is a need to complete studies in both the urban and rural areas of India to test the efficacy, safety and acceptability of this new method in this region. In addition, the transfer of the technology to an Indian manufacturing site is planned, in order to optimize the costs of ring manufacturing as well as improving access to the method when approved. Our specific aims are designed over a 4-year timeline 1).To evaluate the safety and efficacy of a Progesterone vaginal ring in Indian family planning research centers in a comparative study with the Copper-T Intra uterine Device (IUD) in women who are breastfeeding and wish to space out pregnancies. 2) To assess the acceptability of vaginal ring use by Indian women in rural and urban settings. 3) To establish complementary training in Good Clinical Practice (GCP) of the research personnel in the "Human Reproduction Research Centers" (HRRC) of ICMR where the study will be conducted. 4) To optimize the technology of progesterone rings and prepare a transfer of technology to Hindustan Latex in India. The ultimate goal of the project is to seek approval of this new product by the Health Authorities in India and permit access to a safe and effective user-controlled, long-acting method of contraception for women who are breastfeeding.