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OpenTrials
Completed

NCT Number: NCT00472004

Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone 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).

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Key information

Conditions

Vasomotor Symptoms

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Monterrey, Nuevo León, 01090, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Totelle

Tibolone (Livial)

Drug

Tibolone 2.5 mg 1 daily, 1 year duration

Other names: Livial

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

  2. Quality of Life (from baseline to six and twelve months)

    Time frame: 1 year

  3. Treatment Adherence (from baseline to six and twelve months)

    Time frame: 1 year

  4. Breast Tenderness (from baseline to six and twelve months)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 10, 2007
Registry last updated
Oct 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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