Trials / Completed
CompletedNCT00145522
Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women
A Twelve 28-Day Cycles, Multicenter, Prospective, Randomized, Open, Blinded Endpoint, Parallel Group Study Comparing the Effect on Breast and Cardiovascular Metabolic Markers of Continuously Combined 17β-Estradiol/Dydrogesterone and Tibolone in Postmenopausal Women.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Solvay Pharmaceuticals · Industry
- Sex
- Female
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 17ß-Estradiol/Dydrogesterone | 1/5 mg/day for 12 cycles of 28 days |
| DRUG | Tibolone | 2,5 mg/day for 12 cycles of 28 days |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2005-09-05
- Last updated
- 2009-04-01
Locations
11 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00145522. Inclusion in this directory is not an endorsement.