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

Last updated on October 5, 2018

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Study Location
Pfizer Investigational Site
Monterrey, Nuevo Leon, 01090 Mexico
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vasomotor Symptoms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known or suspected estrogen-dependent neoplasia

- Endometrial hyperplasia

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

NCT00472004
Pfizer
Completed
Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

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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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: Female
45 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00472004
0753T-101800
B2481004
No
Not Provided
Not Provided
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

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