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.

Public Health Relevance

There is a great unmet need in the developing world for contraceptive methods that women can use postpartum to postpone their return to fertility. In developing countries, urbanization has reduced the duration of breastfeeding and its effectiveness as a contraceptive method;while women who are fully-nursing their infants and are amenorrheic have a low risk of pregnancy, the proportion of women meeting these criteria decrease over time. The purpose of this project is to complete the development of a progesterone vaginal ring that was shown to be effective in previous clinical studies to prolong lactational amenorrhea and for the spacing of pregnancies.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD061106-03
Application #
8296621
Study Section
Special Emphasis Panel (ZHD1-DSR-Z (24))
Program Officer
Kaufman, Steven
Project Start
2010-05-01
Project End
2014-04-30
Budget Start
2012-05-01
Budget End
2013-04-30
Support Year
3
Fiscal Year
2012
Total Cost
$330,394
Indirect Cost
$114,394
Name
Population Council
Department
Type
DUNS #
071050090
City
New York
State
NY
Country
United States
Zip Code
10017
Sitruk-Ware, Regine; Nath, Anita; Mishell Jr, Daniel R (2013) Contraception technology: past, present and future. Contraception 87:319-30
Sitruk-Ware, R; El-Etr, M (2013) Progesterone and related progestins: potential new health benefits. Climacteric 16 Suppl 1:69-78