Abstract

This project focuses on leiomyomata (fibroids) and examines factors related to their pathogenesis, diagnosis and/or potential treatment. Ongoing work seeks to evaluate the utility of the progesterone response modulator CDB2914 as a treatment of fibroids. We previously investigated the effect of single doses of the agent on the menstrual cycle in women, and showed that doses of 100 or 200 mg retard folliculogenesis and precipitate menses, in the follicular and luteal phase respectively. Two randomized double-blind placebo-controlled clinical trials from our group showed reduction in fibroid size in women receiving CDB 2914 at a daily dose of 10 or 20 mg for three months, as compared to women receiving placebo. One of these studies showed continued efficacy during a second three-month study. We also are using gene arrays to evaluate the pathophysiology of leiomyomata.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIAHD000637-20
Application #
8736820
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
20
Fiscal Year
2013
Total Cost
$93,045
Indirect Cost

  Institution

Name
Eunice Kennedy Shriver National Institute of Child Health & Human Development
Department
Type
DUNS #
City
State
Country
Zip Code

  Publications

Martinez, Pedro E; Rubinow, David R; Nieman, Lynnette K et al. (2016) 5?-Reductase Inhibition Prevents the Luteal Phase Increase in Plasma Allopregnanolone Levels and Mitigates Symptoms in Women with Premenstrual Dysphoric Disorder. Neuropsychopharmacology 41:1093-102
Schmidt, Peter J; Ben Dor, Rivka; Martinez, Pedro E et al. (2015) Effects of Estradiol Withdrawal on Mood in Women With Past Perimenopausal Depression: A Randomized Clinical Trial. JAMA Psychiatry 72:714-26
Lewis, Erin I; Chason, Rebecca J; DeCherney, Alan H et al. (2013) Novel hormone treatment of benign metastasizing leiomyoma: an analysis of five cases and literature review. Fertil Steril 99:2017-24
Lee, Ellen E; Nieman, Lynnette K; Martinez, Pedro E et al. (2012) ACTH and cortisol response to Dex/CRH testing in women with and without premenstrual dysphoria during GnRH agonist-induced hypogonadism and ovarian steroid replacement. J Clin Endocrinol Metab 97:1887-96
Nieman, Lynnette K; Blocker, Wendy; Nansel, Tonja et al. (2011) Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study. Fertil Steril 95:767-72.e1-2
Smith, Kathryn; Alnifaidy, Redab; Wei, Qingxiang et al. (2011) Endometrial Indian hedgehog expression is decreased in women with endometriosis. Fertil Steril 95:2738-41.e1-3
Stratton, Pamela; Levens, Eric D; Hartog, Beth et al. (2010) Endometrial effects of a single early luteal dose of the selective progesterone receptor modulator CDB-2914. Fertil Steril 93:2035-41
McCarthy-Keith, Desireé; Nurudeen, Sahadat; Armstrong, Alicia et al. (2010) Recruitment and retention of women for clinical leiomyoma trials. Contemp Clin Trials 31:44-8
Levens, Eric D; Wesley, Robert; Premkumar, Ahalya et al. (2009) Magnetic resonance imaging and transvaginal ultrasound for determining fibroid burden: implications for research and clinical care. Am J Obstet Gynecol 200:537.e1-7
Stegmann, Barbara J; Funk, Michele Jonsson; Sinaii, Ninet et al. (2009) A logistic model for the prediction of endometriosis. Fertil Steril 91:51-5

Showing the most recent 10 out of 12 publications