NCT00145522

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2005

Typical duration for phase_4

Geographic Reach
1 country

11 active sites

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

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 1, 2009

Status Verified

March 1, 2009

Enrollment Period

3.3 years

First QC Date

September 2, 2005

Last Update Submit

March 31, 2009

Conditions

Menopause

Keywords

Menopause, IGF-1, HRT

Outcome Measures

Primary Outcomes (1)

  • IGF1 values after 12 cycles of 28 days

    1 year

Secondary Outcomes (1)

  • 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

    1 year

Study Arms (2)

1

EXPERIMENTAL
Drug: 17ß-Estradiol/Dydrogesterone

2

ACTIVE COMPARATOR
Drug: Tibolone

Interventions

17ß-Estradiol/DydrogesteroneDRUG

1/5 mg/day for 12 cycles of 28 days

1
TiboloneDRUG

2,5 mg/day for 12 cycles of 28 days

2

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Site 8

Ancona, Italy

Location

Site 15

Cagliari, Italy

Location

Site 4

Catania, Italy

Location

Site 9

Florence, Italy

Location

Site 10

Milan, Italy

Location

Site 11

Milan, Italy

Location

Sit 14

Modena, Italy

Location

Site 6

Roma, Italy

Location

Site 1

Torino, Italy

Location

Site 2

Torino, Italy

Location

Site 7

Udine, Italy

Location

MeSH Terms

Interventions

Dydrogesteronetibolone

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    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

September 2, 2005

First Posted

September 5, 2005

Study Start

November 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 1, 2009

Record last verified: 2009-03

Locations

IT(11)