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  1. Women's Health Research

OWH-Funded Research: Other

The FDA Office of Women’s Health (OWH) awards research grants for 1-2 year studies to support FDA regulatory decision-making and advance the science of women’s health. OWH has funded research projects that address health issues affecting women across their lifespan. This page highlights OWH-funded research related to breast implants, cosmetics, dietary supplements, feminine hygiene and other topics.

Learn about other OWH-funded research

Breast Implants, Cosmetics / Skin, Diet / Obesity, Dietary Supplement / Safety, Feminine Hygiene, Hormone / Endocrine Disruptors, Infant Feeding,  Infectious Disease, Osteoporosis and Bone Health, Other

Breast Implants

MRI Safety Testing of Breast Tissue Expanders used in Mastectomy Patients - Sunder Rajan, PhD, CDRH (13)

MRI and Ultrasound imaging of silicone filled breast implants – Rajan Sunder, PhD, CDRH (11)

Abrasion testing of breast implants - Patricia Dubill, PhD, CDRH (98)

Protocol for a study of breast implant rupture - S. Lori Brown, MD, CDRH (97)

A study of safety of silicone breast implants - IOM study, Institute of Medicine/S. Lori Brown, MD, CDRH (97)

Development of a safe, economical assay for silicone containment in blood and tissue - Marwood N. Ediger, PhD, CDRH (96)

Mechanism of immunotoxicity and carcinogenicity associated with silicone breast implants - S. Jill James, PhD, NCTR (95)

Noninvasive assessment of silicone migration from gel-filled breast implants - Kyle Myers, PhD, CDRH (95)

Silicone Gel Alternatives Workshop - John Langone, PhD, CDRH (94)

Immunogenetic risk factors for silicone-associated multiple myeloma and monoclonal gammopathy of undetermined significance - Frederick Miller, MD, PhD, CBER (94,98)

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Cosmetics / Skin

Effect of Injection Techniques, Materials Chemistry and Physical Properties of Dermal Fillers on Potential for Bacterial Colonization and Infection - Kenneth Phillips. PhD, CDRH (13)

Risk Assessment of Human Skin Microflora Metabolism of Synthetic Azo Colorants used in Women’s Cosmetics - Huizhong Chen, PhD, NCTR (08)

Optimization of UV exposure patterns:  Maximizing perceived benefits while minimizing photocarcinogenic and photoaging effects, Sharon Miller, MS, CDRH (01)

Latex allergy genomics study: Developing a diagnostic gene expression microarray for Type 1 latex allergy using transcriptome profiling - Rosalie Elespuru, PhD, CDRH (01)

Birth defect potential of cosmetic products containing retinol (vitamin A) and retinyl palmitate - Jeffrey Yourick, PhD, CFSAN (00)

Evaluation of the Tg.Ac transgenic mouse as a model for predicting the photocarcinogenicity of pharmaceuticals and cosmeceuticals - Ronald Honchel, PhD, CDER (99)

Potential Exposure of Women to Estrogens, Phytoestrogens and Xenoestrogens through Cosmetic Products, Robert Bronaugh, PhD, CFSAN (99)

Cosmetics Initiatives Alpha Hydroxy Acids (AHAs), John E. Bailey, Ph.D., CFSAN (94)

AHA Literature Search, John E. Bailey, PhD, CFSAN (94)

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Diet / Obesity

Review of herbal weight loss product experiences and adverse events - Sara Warber, MD, Univ. of Michigan (00)

Breast cancer in African-American women: Metabolic modification of dietary and hormonal risk factors - Christine Ambrosone, PhD, NCTR (97)

Obesity: Its effect on antioxicant and estrogen metabolism - Shirley Blakely, PhD, CFSAN (97)

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Dietary Supplement / Safety

Hepatotoxicity database for herbal/dietary supplements - Weida Tong, PhD/NCTR (16)

Herbal and Dietary Supplements (HDS) are considered by the public to be safe. Estimates suggest HDS usage by approximately 80% of the population. In the US, herbs are defined as dietary supplements. Therefore, manufacturers are not requested to demonstrate safety as it would be required for drugs. Recent research is highly suggestive for different, due to inappropriate controls, serious side effects most notable hepatotoxicity. From 2004-2013, CDER received over 400 botanical Investigational New Drug (IND) applications and pre-IND meeting requests. Most INDs were allowed to enter Phase 2 clinical trials for evaluation of preliminary safety and efficacy of the investigational botanical products in patients. HDS are more frequently used by women than men and the same applies to minority populations. In order to avoid risk to the public health, it is the interest of the FDA to identify the hepatotoxic potential of HDS prior to market release and to protect populations at high risk including women and minority groups. In this study, we will investigate and provide a comprehensive assessment of hepatotoxic potential of HDS. We will research all available data relating to HDS consumption with emphasis on women and minority populations from various sources (i.e., public databases, literature and data from the regulatory agencies worldwide) and the data will be organized using the standard terminologies so that the information from diverse sources can be compared and analyzed. The outcome of the study is a database that could be a resource to support the FDA review to reduce the health disparities for women and minority groups. Having a database of hepatotoxicity findings for commercially available dietary supplements could enhance our understanding of the safety profiles of those botanicals and thus help us to make more informed decision for botanical IND reviews.

Detection of synthetic drugs as adulterants in natural and herbal slimming products by UPLC-mass spectrometry - Phyllis Wilson, PhD, ORA (14)

Effects of phytoestrogens on gene expression responses of vaginal epithelial cells after contact with candida albicans - R. Doug Wagner, PhD, NCTR (10)

Computational human health effects study to assess the safety of botanical extracts widely used by women in the United States for treatment of menopausal symptoms - Luis Valerio, PhD, CDER (09)

Understanding Consumer Behavior Associated with Changing Messages on Listeria monocytogenes and Food Safety - Elizabeth Calvey, PhD/ Marjorie Davidson, PhD, CFSAN (07)

Phytoestrogens: Drug interaction potential in women - Gail Anderson, PhD, Univ. of Washington (00)

Use and interaction of dietary supplements in the SEA Trial - Mara Vitolins, DrPH, Wake Forest Univ. (00)

The effects of St Johns Wort on the efficacy of oral contraception - Stephen Hall, PhD, Indiana University (00)

Effects of dietary soy and calcium supplementation on lipid levels, brachial artery function, biochemcial markers of bone turnover, inflammatory markers of atherosclerosis and menopuasal symptioms in postmenopausal women - Francine Welty, MD PhD, Beth Israel Deaconess Medical Center and Harvard Univ. (00)

Pattern of botanical dietary supplement usage in menopausal women - Gail Mahady, PhD, Univ. of Illinois at Chicago (00)

Contaminants in dietary supplements frequently used in women - Nancy Slifman, MD, MPH, CFSAN (98)

Vitamin K status of non-Hispanic balck and white girls and young adult women: direct measure of serum phylloquinone levels and measurement of a new functional endpoint in serum samples from NHANES II - Mona Calvo, PhD, CFSAN (97)

Women’s Health Information Line, Ruth Welch, MS, CFSAN (96)

CFSAN’s Women’s Health Internet Initiative: Phase II, Kenneth T. Durham, CFSAN (96)

CFSAN’s Women’s Health Internet Initiative - Phase I, Kenneth T. Durham, CFSAN (95)

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Feminine Hygiene

Drug-delivery nanoparticle immunological effects on induction of pro-inflammatory responses to Candida albicans in mice - Doug Wagner, PhD/NCTR (16)

Delivery of drugs to women by direct application to the vaginal tract may be improved by use of very small chemical structures called nanoparticles. In previous research, we have found that certain dissolving drug-delivery nanoparticles are toxic to vaginal cells and cause the cells to recruit inflammation. When the same material is used in medical devices larger than 1 micrometer in size inserted into the body, it is not toxic. These drug-delivery nanoparticles may be used to provide medicines into a women’s vaginal tract when she has a yeast infection. Vaginal yeast infections often cause inflammation. We propose to conduct experiments in a mouse model of inflammatory vaginal yeast infections to determine whether the nanoparticles make the inflammation during yeast infections worse. This will provide important knowledge for FDA to make regulatory decisions regarding when it will be appropriate to use these kinds of drug-delivery nanoparticles. In the experiments, mice will be given vaginal yeast infections by an established method and given nanoparticles into their vaginal tracts at doses similar to those that would be used to treat women with drugs, such as those that prevent viral infections. We will measure the damage to DNA and cellular machinery of the vaginal tissue by the nanoparticles as well as the inflammation that occurs with or without yeast infections. We will also determine whether the nanoparticles cause the yeast infections to spread into the body. Vaginal drug delivery in nanoparticles is a promising new technology to improve women’s health, but the risks of their use during a common yeast infection have not been determined. This project will allow us a better understanding of those risks.

Evaluating the migration and toxic potential of silver nanoparticles in feminine hygiene products into vaginal tissue: In vivo rodent and human in vitro 3D mucosal models - Yongbin Zhang, DVM, PhD/NCTR (16)

There is increasing manufacturing and market interest in the development of more effective feminine hygiene products. These developments are usually based on improvements in manufacture or fiber/polymer technology, and lately, the ability to manufacture nanoscale materials that reportedly have bacteriostatic/bactericidal properties. Some feminine hygiene products (e.g. cleansers and pads) currently available on the market claim to include nanoscale silver. Nanomaterials in feminine hygiene products potentially could migrate into vaginal tissue and become a hazard to the consumer. A key challenge for biomedical research on nanomaterials is understanding the biological fate of nanomaterials (where do the materials go; do they have any effect) and the cumulative risk following daily use/exposure (does the effect accumulate/increase with continued use; does the material and effect go away when use stops). This study will use both in vitro cell culture and a rodent model to examine the penetration/permeation of different species of silver (nanoparticles, nanoparticle agglomerates, and silver ions) into vaginal mucosal tissue. In addition the toxic potential of the silver species will be examined on vaginal mucosal tissue and the microbiota found in the vaginal environment. This project takes advantage of the outstanding facilities available at the collaborating laboratories, and the NCTR-ORA Nanotechnology Core Facility at FDA’s Jefferson Laboratories campus.

Evaluation of methods used to measure growth of staphylococcus aureus and the production of toxic shock syndrome toxin-1 as influenced by menstrual tampons - Mark E. Hart, PhD, NCTR (14)

Nanoparticle Effects on Induction of Pro-inflammatory Responses to Candida albicans by Cultured Vaginal Epithelial Cells - Robert Wagner, PhD, NCTR (13)

Detection of Nanoscale Materials in Products Targeted to Women: Feminine Hygiene Products and Dietary Supplements - Linder Sean, PhD, ORA (11)

Application of co-culture and simulated vaginal models to elucidate the inhibitory properties of naturally occurring and bioengineered strains of lactobacillus toward toxic shock syndrome toxin-1 producing strains of staphylococcus aureus - Mark Hart, PhD, NCTR (09)

Development of a Rapid Version of the Tampon Test Method Based on 21CFR801.430 - Lesley Kerr, ORA (07)

Protective effect of vaginal Lactobacillus species against Staphylococcus Aureus-mediated toxic shock syndrome - Christopher Elkins, PhD, NCTR (06)

Analysis of Dioxins/Furnas Levels in Tampons - Jeff Archer, PhD, ORA (00)

Vaginal volume: optimizing vaginal deployment of topical microbicides - Debra Birnkrant, MD, CDER (00)

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Hormone / Endocrine Disruptors

Investigation of Drug-Drug Interactions with Hormonal Contraceptives - Chongwoo Yu, PhD, CDER (12)

Quantification of drug retained in the skin after removal of estradiol transdermal drug delivery systems used in hormone replacement therapy - Sri Rama Krishnaiah Yellela, PhD, CDER (12)

An investigation of sexual dysfunction in depressive trials – Peiling Yang, PhD, CDER (11)

Effects of body mass index (BMI)/body weight (BW) on effectiveness of hormonal contraceptive products for women – Chongwoo Yu, PhD, CDER (11)

The Role of Estrogen in Controlling Hepatitis C Virus Replication – Deborah Taylor, CBER (11)

Quantum mechanical and NMR spectral approaches for the rapid prediction of estrogen activity of FDA regulated chemicals - Jon Wilkes, PhD, NCTR (10)

Genome wide methylation arrays for detecting markers of increased susceptibility to mammary cancer caused by in utero exposures to endocrine disruptors - Cecilia Aguila, DVM, CVM (09)

The role of estrogen in enhancing innate immunity during viral infection - Deborah Taylor, PhD, CBER (09)

Gene Expression Responses of Estrogen-Primed Vaginal Epithelial Cells After Contact With Candida albicans and Probiotic Lactobacilli - R. Doug Wagner, PhD, NCTR (08)

Evaluation of Inflammation and Sex Hormones as Biological Factors that May Contribute to Gender Differences in Susceptibility to Chemical-Induced Liver Injury – Studies Using Human Liver Cells in Culture - Thomas Flynn, PhD, CFSAN (08)

Evaluating the Effects of Over-the-Counter Skin Products, such as Sunscreen, on the Absorption of Dermally Applied Estradiol, in an In- Vitro and an In-Vivo Model - Nakissa Sadrieh, PhD, CDER (08)

Development and Validation of an HPLC method for the Simultaneous Determination of Estradiol, Estriol, Estrone and Progesterone in Pharmaceutical Preparations - Phyllis Wilson, ORA (07)

The Role of Estrogen in Enhancing Innate Immunity During Viral Infection - Deborah Taylor, PhD, CBER (07)

Modulating effects of estrogen in food allergen induced lung inflammation in a highly sensitive rat model for postmenopausal women(Do Phytoestrogens Modify Asthmatic Response to Food Allergens in Newly Validated, highly sensitive, in-bred asthmatic rat mouse - Mona Calvo, PhD, Maria Lorenzo, DVM, CFSAN (04)

Gender Based Differences in the Vascular Response to Anthrax Toxin: Investigation of the Role of Hormones in an In Vitro Human Endothelial Cell Culture System - Felice D’Agnillo, PhD, CBER (04)

Effect of Sex Hormones on the Immune response of CpG ODN - Daniela Verthelyi, PhD, CBER (02)

Evaluation of the effects of daidzein and genistein (hormone replacement agents) on the genotoxic and carcinogenic activity of the model mammary carcinogen 7,12-dimethylbenz(a)anthracene (DMBA) in ovarectomized transgenic Big Blue rats - Anane Aidoo, PhD, NCTR (00)

Chemical characteristis of conjugated estrogens - Thomas Layloff, PhD, CDER (98)

In-vivo modeling of steroid-mediated gender effects in drug metabolism, Phase I and II - Patricia Thompson, PhD, NCTR (98)

Contribution of estrogen components to the efficacy of conjugated estrogens-preliminary analytical chemistry - John Strong, PhD, Mei-Ling Chen, PhD, CDER (97)

Development of in vitro human cell culture systems to screen compounds suspected to have estrogenic or anti-estrogen activity - William Tolleson, PhD, NCTR (97)

Experimental assessment of environmental estrogens - Dan Sheehan, PhD, NCTR (96)

Development of an estrogen knowledge base for research and regulation - Darnell Carlton Jackson, PhD, NCTR (96)

Hormone replacement therapy in women with a previous diagnosis of endometrial cancer - Bruce V. Stadel, MD, MPH, CDER (95)

Mechanism of tamoxifen development toxicity and neoplasia: Tamoxifen effects on the rat uterine insulin like growth factor system, Randal Streck, PhD/ Dan Sheehan, PhD, NCTR (95)

A novel molecular approach to risk assessment of hormonally active compounds, John Leighton, PhD, CVM (95)

Estimation of reproductive toxicity of pharmaceuticals using QSAR software programs, Edwin Matthews, PhD, CDER (95)

Effects of toremifene and ICI 182,780 on rat uterine growth and differentiation, Dan Sheehan, PhD, NCTR (94)

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Infant Feeding

Ciprofloxacin and Doxycycline in lactating women and in the elderly - Raymond Galinsky, PharmD, Indiana School of Medicine (02)

Development of a general approach for the investigation of drug transfer in breast milk: In vitro assessment of drug distribution into breast milk - Patrick McNamara PhD/ Gerald Fetterly, PhD, CDER (01)

Infant Feeding Practices Study - Sara Fein, PhD, CFSAN (94)

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Infectious Disease

Assessment of Placental Transmission of Zika Virus Glycoprotein E Immunogen - Evi Struble, PhD, Special Funding/CBER (16)

Zika virus infection has reached epidemic proportions in Latin America. Based on the geographical distribution of its mosquito carriers, it is likely that Zika virus will spread to the U.S. Zika infections during pregnancy have been associated with increased number of severe neurologic birth defects in newborn babies. Treatment with human antibodies against Zika virus may become a likely treatment option during pregnancy. Given the limited scientific data on Zika disease and treatment during pregnancy, it is very important to collect and analyze safety and efficacy data for this potential medical intervention. Toward this goal, we propose to use our expertise on placental transfer studies to investigate whether circulating non-neutralizing ZIKV antibody complexes contribute to fetal infection and the potential for interaction with pre-existing immunity to other flaviviruses. We will use monoclonal antibodies and antibodies from individuals that have recovered from the Zika infection in complex with the virus envelope protein E, the viral component that mediates both viral infection of human cells and the host immune response to the Zika virus. Experiments will be performed to evaluate whether Zika protein E/antibody complexes are required for the passage of E protein across a laboratory model of the placental barrier. In addition, we will determine if differences in antibodies produced by different recovered individuals or individuals with antibodies against other mosquito borne viruses can have an effect in the placental transfer of Zika. Our study should provide critical information on what constitutes an efficacious and safe immunoglobulin therapy during pregnancy to benefit the mother and her baby.

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Osteoporosis and Bone Health

Disease systems analysis: towards a generic framework for characterizing disease progression and treatment effects in osteoporosis - Li Li, PhD, CDER (14)

Exploring Potential Safety Issues of PPIs on Osteoporosis in Elderly Women Using the PPI Legacy Database - Zhongjun Luo, MD, PhD, CDER (12)

Assessment of Risk Factors Associated with Exposure to Proton Pump inhibitors and Fracture and CV outcomes in post-menopausal osteoporosis women - Antonio Paredes, PhD, CDER (10)

Do vertebroplasty procedures increase the risk of adjacent level vertebral fractures in osteoporotic women - Srinidhi Nagaraja, PhD, CDRH (09)

Development and Guidelines for Evaluating the Appropriateness of Vertebroplasty Surgery for Patients with Osteoporosis - Jove Graham, PhD, CDRH (04)

A study to evaluate the consistency of T-scores among ultrasound bone measurement devices and the usefulness of these devices for monitoring bone status - Richard Kotz, PhD, CDRH (00)

Development and validation of ultrasonic backscatter measurement for bone density assessment - Keith Wear, PhD, CDRH (98)

Application of ultrasonic tissue characterization to diagnosis of bone disease, Keith Wear, PhD, CDRH (95)

Osteoporosis Prevention in Adolescent Girls, Ruth Welch, MS, RD and Carole Schiffman, CFSAN (95)

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Identifying drugs that cause women-biased hepatotoxicity by reviewing FDA drug approcal packages/labels and FDA maintained databases and conducting comparitive studies in primary hepatocytes of rats - Qiang Shi, PhD, NCTR (12)

The Molecular Assays and Targeted Therapies (MATT) Consortium - Ray Woosley, MD, PhD, Critical Path Institute (06)

Self-Monitoring of Blood Glucose with Finger-Tip versus AST: Effect on Long term Glycemic Control - Caroline Apovian, MD, Boston Univ (03)

Drug update in human mammary gland epithelia - Shinya Ito, MD/ Gerald Fetterly, PhD, CDER (01)

CFSAN’s Internet Initiative: Infra-structure support - Kenneth T. Durham, CFSAN (98)

Research involving human subject committee (RIHSC) - Peter Rheinstein, MD, JD, OC/OEA (95)


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