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

NCT00472004

Last updated date
Study Location
Pfizer Investigational Site
Monterrey, Nuevo Leon, 01090, Mexico
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
Official Title  ICMJE 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.
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vasomotor Symptoms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2010)
204
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2007)
200
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00472004
Other Study ID Numbers  ICMJE 0753T-101800
B2481004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2010

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