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Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00472004
Collaborator
(none)
204
Enrollment
1
Location
2
Arms
46
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)
  • Drug: Tibolone (Livial)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration

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
Other Names:
  • Totelle

    		•
    Active Comparator: 2

    Tibolone 2.5 mg 1 daily, 1 year duration

    Drug: Tibolone (Livial)
    Tibolone 2.5 mg 1 daily, 1 year duration
    Other Names:
  • Livial

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Decreased of Vasomotor Symptoms [from baseline to six and twelve months] [1 year]

    Secondary Outcome Measures

    1. Changes in Body Weight (from baseline to six and twelve months) [1 year]

    2. Quality of Life (from baseline to six and twelve months) [1 year]

    3. Treatment Adherence (from baseline to six and twelve months) [1 year]

    4. Breast Tenderness (from baseline to six and twelve months) [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Generally healthy postmenopausal women

    • Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period

    • At least 1 year of natural occurring amenorrhea

    Exclusion Criteria:

    • Known or suspected estrogen-dependent neoplasia

    • Endometrial hyperplasia

    • Any malignancy with the exception of a history of basal cell carcinoma of the skin

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Monterrey Nuevo Leon Mexico 01090

    Sponsors and Collaborators

    • Wyeth is now a wholly owned subsidiary of Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00472004
    Other Study ID Numbers:
    • 0753T-101800
    • B2481004
    First Posted:
    May 10, 2007
    Last Update Posted:
    Oct 29, 2010
    Last Verified:
    Oct 1, 2010
    Additional relevant MeSH terms:
    Tibolone
    Estradiol

    Study Results

    No Results Posted as of Oct 29, 2010