Trials / Completed
CompletedNCT00472004
Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 204 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- Female
- Age
- 45 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) | 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration |
| DRUG | Tibolone (Livial) | Tibolone 2.5 mg 1 daily, 1 year duration |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2007-05-10
- Last updated
- 2010-10-29
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT00472004. Inclusion in this directory is not an endorsement.