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

描述（由申请人提供）：哺乳期闭经方法（LAM）被认为是推迟哺乳期母亲恢复生育能力和间隔生育的有效方法，但在发展中国家，城市化减少了母乳喂养的持续时间及其作为避孕方法的有效性。该项目的目的是完成孕酮阴道环（PVR）的开发，该环在先前的临床研究中被证明可有效延长LAM和妊娠间隔。然而，有必要在印度的城市和农村地区完成研究，以测试这一新方法在该地区的有效性、安全性和可接受性。此外，还计划将该技术转让给印度的一个生产基地，以优化环的制造成本，并在获得批准后改善该方法的使用。我们的具体目标是在4年时间轴内设计的1）。在印度计划生育研究中心，在母乳喂养和希望间隔怀孕的妇女中进行一项与铜-T宫内节育器（IUD）的比较研究，以评估Progressive阴道环的安全性和有效性。2)评估印度农村和城市妇女使用阴道环的可接受性。3)对将开展研究的ICMR“人类生殖研究中心”（HRRC）的研究人员进行药物临床试验质量管理规范（GCP）补充培训。4)优化孕酮环的技术，并准备将技术转让给印度的Hindustan Latex。该项目的最终目标是寻求印度卫生当局批准这一新产品，并允许母乳喂养的妇女获得安全有效的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.