A Randomized Study of the Effects of Tibolone on Bone Density, Menopausal Symptoms, and Breast Density in High-Risk Women After Prophylactic Oophorectomy
Abstract
The synthetic steroid tibolone has been shown to improve bone mass mitigate menopausal symptoms and reduce breast density in women with natural menopause. It has not been evaluated in an abrupt menopause model as occurs in women at high risk of breast cancer because of inherited risk who undergo prophylactic oophorectomy to reduce breast cancer risk. We had planned to conduct a double-blind randomized placebo-control trial to test the hypotheses that Tibolone would accomplish these goals in high-risk premenopausal women undergoing prophylactic oophorectomy and provide an alternative for them to manage menopause symptoms without increasing breast cancer risk. Unfortunately despite several modifications to the protocol a series of outside events ultimately made it impossible for the project to be completed. Many of the modifications required by the DOD required extensive revisions all of which were in progress until ultimately the final blow: the US FDA determined that the New Drug Application (NDA) submitted for tibolone by Akzo Nobel's human healthcare business Organon is "not approvable". This response follows an amendment to the NDA which Organon filed with the FDA in December 2005. This finally makes it unreasonable to attempt to conduct the trial with an agent that has no future in the U.S. Therefore the project will be withdrawn and unspent funds returned to the Department of Defense.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2006
- Accession Number
- ADA471717
Entities
People
- Hadine Joffe
- Judy Garber
- Meryl S LeBoff
- Nancy U Lin
- Paula Ryan
Organizations
- Dana–Farber Cancer Institute