NCT00472004

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 29, 2010

Status Verified

October 1, 2010

Enrollment Period

3.8 years

First QC Date

May 8, 2007

Last Update Submit

October 28, 2010

Conditions

Vasomotor Symptoms

Outcome Measures

Primary Outcomes (1)

  • Decreased of Vasomotor Symptoms [from baseline to six and twelve months]

    1 year

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

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)

2

ACTIVE COMPARATOR

Tibolone 2.5 mg 1 daily, 1 year duration

Drug: Tibolone (Livial)

Interventions

17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)DRUG

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

Also known as: Totelle
1
Tibolone (Livial)DRUG

Tibolone 2.5 mg 1 daily, 1 year duration

Also known as: Livial
2

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Known or suspected estrogen-dependent neoplasia
  • Endometrial hyperplasia
  • Any malignancy with the exception of a history of basal cell carcinoma of the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Monterrey, Nuevo León, 01090, Mexico

Location

Related Links

MeSH Terms

Interventions

tibolone

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2007

First Posted

May 10, 2007

Study Start

February 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 29, 2010

Record last verified: 2010-10

Locations

ME(1)