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

描述（由申请人提供）：哺乳期闭经法（LAM）被认为是推迟哺乳母亲恢复生育和间隔生育的有效手段，然而在发展中国家，城市化减少了母乳喂养的持续时间及其作为一种避孕方法的有效性。该项目的目的是完成黄体酮阴道环（PVR）的开发，该环在以前的临床研究中被证明对延长LAM和怀孕间隔有效。然而，有必要在印度的城市和农村地区完成研究，以测试这种新方法在该地区的有效性、安全性和可接受性。此外，计划将该技术转移到印度的制造基地，以优化环制造的成本，并在获得批准后改善对该方法的获取。我们的具体目标是在4年内制定的。在印度计划生育研究中心，对孕酮阴道环与铜- t宫内节育器（IUD）在母乳喂养和希望间隔怀孕妇女中的安全性和有效性进行比较研究。2)评估印度妇女在农村和城市环境中使用阴道环的可接受性。3)为ICMR“人类生殖研究中心”（HRRC）的研究人员建立良好临床规范（GCP）的补充培训。4)优化孕酮环生产工艺，准备向印度印度斯坦乳胶公司转让技术。该项目的最终目标是争取印度卫生当局批准这种新产品，并允许母乳喂养妇女获得一种安全有效、由用户控制的长效避孕方法。

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.