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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00472004
First received: May 8, 2007
Last updated: October 28, 2010
Last verified: October 2010

May 8, 2007
October 28, 2010
February 2006
December 2009   (final data collection date for primary outcome measure)
Decreased of Vasomotor Symptoms [from baseline to six and twelve months] [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evaluate the efficacy of Totelle and Tibolone in controlling the vasomotor symptoms and cycle control
Complete list of historical versions of study NCT00472004 on ClinicalTrials.gov Archive Site
  • Changes in Body Weight (from baseline to six and twelve months) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of Life (from baseline to six and twelve months) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Treatment Adherence (from baseline to six and twelve months) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Breast Tenderness (from baseline to six and twelve months) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Evaluate the effects of Totelle and Tibolone on tolerability profile defined as: weight changes, breast tenderness; Quality of Life and Adherence to Treatment
Not Provided
Not Provided
 
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.

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vasomotor Symptoms
  • 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 Name: Totelle
  • Drug: Tibolone (Livial)
    Tibolone 2.5 mg 1 daily, 1 year duration
    Other Name: Livial
  • Active Comparator: 1
    17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration
    Intervention: Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)
  • Active Comparator: 2
    Tibolone 2.5 mg 1 daily, 1 year duration
    Intervention: Drug: Tibolone (Livial)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
45 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00472004
0753T-101800, B2481004
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP