# Formulation development and testing of a novel non-hormonal intravaginal ring to prevent pregnancy and sexually transmitted infections

> **NIH NIH P50** · POPULATION COUNCIL · 2021 · $871,861

## Abstract

PROJECT I – ABSTRACT
Despite extensive choice and increasing availability, current contraceptive options are not meeting the needs of
many women, as is evident by high levels of typical-use failure, method non-use, switching, and discontinuation.
Approximately half of all pregnancies (121 million) around the world are unintended and 218 million women have
an unmet need for effective contraception. New technologies having attributes more closely aligned with users’
needs and expectations are urgently needed to fill this critical gap in sexual and reproductive healthcare. The
overall goal of this P50 center is to bring together some of the leading research organizations in the world with
unrivalled expertise and know-how around design, manufacture and testing of intravaginal ring (IVR) technology
– including Population Council (PC), Queen's University Belfast (QUB), and Weill Cornell Medical College
(WCMC) – in a concerted effort to develop a new, practical, easy-to-use, long-acting, multipurpose prevention
technology (MPT) IVR offering both spermicidal activity and broad antibacterial/antiviral activity against various
common sexually transmitted/vaginal infections, including chlamydia, gonorrhea, bacterial vaginosis (BV), and
infection with herpes simplex virus type 2 (HSV-2) and human immunodeficiency virus (HIV). Unlike other
marketed and experimental contraceptive IVR products, we are committed here to the development of a non-
hormonal contraceptive strategy, referred to as the CZL-IVR, in which copper ions or copper salts (C), zinc ions
or zinc salts (Z), and lactide (L) are simultaneously administered to the vagina in a sustained/controlled manner
over at least 30 days. The overarching goal of Project 2, which involves a strategic and highly integrated
partnership between Queen's University Belfast (QUB) and Population Council (PC), is to provide
formulation support for the P50 project. Specifically, this will involve all aspects of CZL-IVR product
design, formulation, manufacture and in vitro testing, according to three key aims: In Aim 1, we will
develop a CZL-IVR that releases copper, zinc and lactide for at least 30 days in quantities sufficient for
clinical efficacy; in Aim 2, we will design, manufacture and characterize non-medicated IVRs and sensor-
embedded IVRs for end-user testing; and in Aim 3, we will complete technology transfer between QUB
and PC and GMP manufacture the IVRs for clinical evaluation for Project 3. Project 1 will be closely
coordinated with Projects 2 and 3 to inform IVR loading and selection of the lead IVR. Our multidisciplinary
collaborative team is uniquely qualified to advance the development of this novel MPT IVR. The CZL-IVR will
address a critical gap in the non-hormonal contraceptive landscape, fill a niche that users want and deliver an
important public health intervention.

## Key facts

- **NIH application ID:** 10324916
- **Project number:** 1P50HD106793-01
- **Recipient organization:** POPULATION COUNCIL
- **Principal Investigator:** BRUCE F VARIANO
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $871,861
- **Award type:** 1
- **Project period:** 2021-09-22 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10324916

## Citation

> US National Institutes of Health, RePORTER application 10324916, Formulation development and testing of a novel non-hormonal intravaginal ring to prevent pregnancy and sexually transmitted infections (1P50HD106793-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10324916. Licensed CC0.

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