This scientific workshop will provide an opportunity for FDA to obtain input from experts on several topics related to the product label of lower dose estrogen-alone products approved solely for the treatment of moderate to severe symptoms of VVA due to menopause. The discussion topics will include:
- The relevance of the Boxed Warnings based on data from the Women’s Health Initiative (WHI) to the lower dose estrogen-alone products. The Boxed Warnings include: (1) not using estrogen for the prevention of cardiovascular disease or dementia, (2) an increased risk of stroke and deep vein thrombosis in women treated with estrogen-alone, and (3) an increased risk of probable dementia in postmenopausal women 65 years of age and older treated with estrogen-alone.
- Educating prescribers on the interpretation of estrogen systemic exposure data across various estrogen dosages and dosage forms approved for the treatment of moderate to severe symptoms of VVA due to menopause. A presentation will include basic pharmacokinetic (PK) and clinical pharmacology concepts and an informed framework for comparing various estrogen products for prescribing purposes.
- Discussion of the relationship between serum estrogen concentrations and important adverse outcomes, such as pulmonary embolism, deep venous thrombosis, and myocardial infarction.
- Presentation and discussion of pharmacodynamic (PD) biomarkers of thrombosis , including a discussion of comparisons of PK profiles from various estrogen products, the effect of estrogens on key clotting factors responsible for thrombosis, and the relationship between PK and PD across estrogen products.
November 10, 2015
8:30 a.m. to 5:00 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 B and C
Silver Spring, MD 20993
To register to attend or view a live Web cast of this meeting, email: FDAVVAworkshop@fda.hhs.gov
Submitting comments to the public docket
In addition to providing input at this public meeting, stakeholders are invited to provide their perspectives through the public docket either through written or electronic comments. The docket closes on October 16, 2015:
- Visit the following website to submit your comments