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).

Study Overview

• Status: Completed
• Conditions: Vasomotor Symptoms
• Intervention / Treatment: Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle); Drug: Tibolone (Livial)

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 01090
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decreased of Vasomotor Symptoms [from baseline to six and twelve months]	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Body Weight (from baseline to six and twelve months)	1 year
Quality of Life (from baseline to six and twelve months)	1 year
Treatment Adherence (from baseline to six and twelve months)	1 year
Breast Tenderness (from baseline to six and twelve months)	1 year

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 8, 2007
• First Submitted That Met QC Criteria: May 8, 2007
• First Posted (Estimate): May 10, 2007

Study Record Updates

• Last Update Posted (Estimate): October 29, 2010
• Last Update Submitted That Met QC Criteria: October 28, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antihypertensive Agents; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Estrogens; Hormone Antagonists; Estrogen Receptor Modulators; Androgen Antagonists; Anabolic Agents; Estradiol; Tibolone
• Other Study ID Numbers: 0753T-101800; B2481004