Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women

March 31, 2009 updated by: Solvay Pharmaceuticals

A Twelve 28-Day Cycles, Multicenter, Prospective, Randomized, Open, Blinded Endpoint, Parallel Group Study Comparing the Effect on Breast and Cardiovascular Metabolic Markers of Continuously Combined 17β-Estradiol/Dydrogesterone and Tibolone in Postmenopausal Women.

This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Site 8
      • Cagliari, Italy
        • Site 15
      • Catania, Italy
        • Site 4
      • Firenze, Italy
        • Site 9
      • Milano, Italy
        • Site 10
      • Milano, Italy
        • Site 11
      • Modena, Italy
        • Sit 14
      • Roma, Italy
        • Site 6
      • Torino, Italy
        • Site 1
      • Torino, Italy
        • Site 2
      • Udine, Italy
        • Site 7

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
  • non hysterectomized women, complaining of at least 14 hot flushes per week

Exclusion Criteria:

  • Known, suspected or history of breast cancer or hormone-dependent neoplasia,
  • undiagnosed genital bleeding,
  • venous or arterial history or presence of thromboembolism,
  • cerebrovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: 17ß-Estradiol/Dydrogesterone
1/5 mg/day for 12 cycles of 28 days
Active Comparator: 2
Drug: Tibolone
2,5 mg/day for 12 cycles of 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IGF1 values after 12 cycles of 28 days
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
after 12 cycles of 28 days: other breast metabolic markers [IGFBP 1 and 3, SHBG, free estradiol, fasting insulin], breast tenderness and breast density, cardiovascular metabolic markers, menopausal symptoms and bleeding pattern
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

April 1, 2009

Last Update Submitted That Met QC Criteria

March 31, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S102.4.103
  • 2004-001829-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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