Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00145522
First received: September 2, 2005
Last updated: March 31, 2009
Last verified: March 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause |
Drug: 17ß-Estradiol/Dydrogesterone Drug: Tibolone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by Solvay Pharmaceuticals:
Primary Outcome Measures:
- IGF1 values after 12 cycles of 28 days [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 135 |
| Study Start Date: | November 2005 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145522
Locations
| Italy | |
| Site 8 | |
| Ancona, Italy | |
| Site 15 | |
| Cagliari, Italy | |
| Site 4 | |
| Catania, Italy | |
| Site 9 | |
| Firenze, Italy | |
| Site 11 | |
| Milano, Italy | |
| Site 10 | |
| Milano, Italy | |
| Sit 14 | |
| Modena, Italy | |
| Site 6 | |
| Roma, Italy | |
| Site 1 | |
| Torino, Italy | |
| Site 2 | |
| Torino, Italy | |
| Site 7 | |
| Udine, Italy | |
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Irene Grazioli, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00145522 History of Changes |
| Other Study ID Numbers: | S102.4.103, 2004-001829-22 |
| Study First Received: | September 2, 2005 |
| Last Updated: | March 31, 2009 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Solvay Pharmaceuticals:
|
Menopause, IGF-1, HRT |
Additional relevant MeSH terms:
|
Dydrogesterone Estradiol Polyestradiol phosphate Tibolone Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Estrogens |
Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Androgen Antagonists Hormone Antagonists Antihypertensive Agents Cardiovascular Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Modulators Anabolic Agents |
ClinicalTrials.gov processed this record on May 22, 2013