Trials / Completed
CompletedNCT00725374
A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469)
A Exploratory, Double-blind, Randomized, Placebo-controlled Trial to Investigate the Tissue Specific Effects of 2.5 mg Tibolone on Breast Cancer in Postmenopausal Women, in Particular on Breast Tissue Proliferation.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to compare changes in the expression of the proliferation marker Ki-67 in malignant breast tissue after treatment with tibolone or placebo in postmenopausal women who need to undergo surgery for primary breast cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tibolone | one tablet of 2.5 mg tibolone, per day, every day, for 14 ± 2 days (until the day before surgery). |
| DRUG | placebo | Subjects were to take one tablet of tibolone-matched placebo, per day, every day, for 14 ± 2 days (until the day before surgery). |
Timeline
- Start date
- 2002-12-15
- Primary completion
- 2005-04-15
- Completion
- 2005-04-15
- First posted
- 2008-07-30
- Last updated
- 2024-08-15
Source: ClinicalTrials.gov record NCT00725374. Inclusion in this directory is not an endorsement.