Below you will find information about planned research on cervical barriers and female condoms.
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Phase I safety study of the SILCS diaphragm used with Contragel
Randomized, parallel double-blind Phase I study
The purpose of this study is to determine systemic and genitourinary safety of Contragel used with the SILCS diaphragm vs. the HEC Universal Placebo gel used with the SILCS diaphragm during two 7-day periods of daily use, the first without intercourse and the second with intercourse.
This single-center randomized, parallel double-blind Phase I study will be conducted in 24 healthy premenopausal women protected from pregnancy. Participants will be randomized in a 1:1 ratio to insert the SILCS diaphragm used with either Contragel or the HEC Universal Placebo gel every day for two 7-day periods in two separate menstrual cycles.
Protocol is in development. The start date is anticipated in Q3 2015, depending on ethics approval from the relevant IRB. The study is scheduled to be completed by July/August 2016.
This study will be implemented by CONRAD at the Eastern Virginia Medical School. The study is funded by USAID.
A randomized crossover trial of the functional performance, safety, and acceptability of the Origami Internal Condom
Randomized crossover study
Location: South Africa
The Origami Internal Condom is a new condom that has been designed to be used for either anal or vaginal sexual intercourse. This randomized comparative crossover trial will evaluate functional performance, safety, and acceptability of the Origami Internal Condom compared to FC2. The study will enroll 28 couples (14 heterosexual for vaginal use and 14 homosexual for anal use) agreeing to use five each of the two condom types.
The fieldwork will commence in mid-2015.
The study is funded by the Bill and Melinda Gates Foundation via Origami Healthcare Products, and will be implemented by MatCH Research.
Introduction of new female condom products: Lessons from dual programming in South Africa
Location: South Africa
In recent years the development of new female condom products has become a reality, and several female condoms are in various stages of regulatory approval. Although this has the potential to widen choice and lower product costs, there are other considerations that need to be addressed. New products vary considerably in design, material, and method of insertion and once available, providers and users will need to be trained on the use of new female condoms. Up to 2013, only the FC2 female condom was available in South Africa. In 2014, Cupid and the Pleasuremore female condoms were introduced into some public and non-public sector sites in South Africa.
This project is in the planning phase and will assess the introduction of new female condom products in South Africa through interviews with providers and clients, commencing in mid-2015.
The study is funded by the Universal Access to Female Condoms Joint Programme (UAFC), and will be implemented by MatCH Research.