# CCTN - CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION

> **NIH NIH N01** · EASTERN VIRGINIA MEDICAL SCHOOL · 2020 · $90,042

## Abstract

The Eunice Kennedy Shriver National Institute of Child Health and Human Development 
(NICHD) has a mission to develop safe and effective contraceptives for women, including obese 
women. Obesity is the number one public health issue facing the US population and is an 
independent risk factor for venous thromboembolism (VTE). Therefore, there is a public health 
need to develop effective contraception for obese woman that does not increase the risk ofVTE. 
Products containing the synthetic estrogen, ethinyl estradiol, have been associated with a dosedependent 
increase in VTE. Products containing the natural hormone, estradiol, or progestinonly 
products have the potential for a much lower risk ofVTE. One example of such potentially 
safer products is a new contraceptive vaginal ring (CVR) that can deliver a continuous dose of 
Nestorone (Nes) and estradiol (E2). The Nes/E2 ring has the potential to provide effective long 
term contraception without the need for daily intervention. Examples of safer progestin-only 
methods are levonorgestrel formulations (patch or injection) or desogestrel (pill). In order to 
evaluate if new products could be effective for contraception, a clinical trial will be conducted in 
the NICHD Contraceptive Clinical Trials Network (CCTN). The proposed study will be 
conducted in women of reproductive age in order to evaluate contraceptive efficacy, 
pharmacokinetics, bleeding patterns, and the safety and side effects of this new contraceptive 
product. In the event of substantial product delay or failure, reprioritization may result in testing 
of a different product in the CDDB development pipeline. In such cases, the scope and 
objectives remain the same and the specifics of the technical requirements will be modified 
according to the latest approved protocol.

## Key facts

- **NIH application ID:** 10264757
- **Project number:** 275201300019I-P00003-27500003-1
- **Recipient organization:** EASTERN VIRGINIA MEDICAL SCHOOL
- **Principal Investigator:** DAVID F. ARCHER
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $90,042
- **Award type:** —
- **Project period:** 2014-09-19 → 2020-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10264757

## Citation

> US National Institutes of Health, RePORTER application 10264757, CCTN - CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION (275201300019I-P00003-27500003-1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10264757. Licensed CC0.

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