MenopausePhase 4NCT00145522
Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women
A Phase 4 study testing 17ß-Estradiol/Dydrogesterone and Tibolone in people with Menopause, run by Solvay Pharmaceuticals at 11 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- 17ß-Estradiol/Dydrogesterone and Tibolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 11 sitesItaly
- Study dates
- Nov 2005to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
- non hysterectomized women, complaining of at least 14 hot flushes per week
Who cannot join
- Known, suspected or history of breast cancer or hormone-dependent neoplasia,
- undiagnosed genital bleeding,
- venous or arterial history or presence of thromboembolism,
- cerebrovascular disease
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Site 8
Ancona
Site 15
Cagliari
Site 4
Catania
Site 9
Florence
Site 10
Milan
Site 11
Milan
Sit 14
Modena
Site 6
Roma
Site 1
Torino
Site 2
Torino
Site 7
Udine
About this study
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.
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.
- Conditions
- Menopause
- Being tested
- 17ß-Estradiol/Dydrogesterone, Tibolone
- Keywords
- Menopause, IGF-1, HRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17ß-Estradiol/DydrogesteroneDrug
1/5 mg/day for 12 cycles of 28 days
TiboloneDrug
2,5 mg/day for 12 cycles of 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 17ß-Estradiol/Dydrogesterone |
| 2 | Active comparator | Not described Receives: Drug: Tibolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF1 values after 12 cycles of 28 days
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145522
- Sponsor's protocol ID
- S102.4.103
- Other IDs
- 2004-001829-22, 2004
- Status last verified
- Mar 2009
- First submitted
- 2 Sep 2005
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00145522
- Acronym / sponsor ID
- S102.4.103
- Conditions
- Menopause
- Keywords
- Menopause, IGF-1, HRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 17ß-Estradiol/Dydrogesterone |
| 2 | Active comparator | Drug: Tibolone |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
- non hysterectomized women, complaining of at least 14 hot flushes per week
Key exclusion criteria (4 listed)
- Known, suspected or history of breast cancer or hormone-dependent neoplasia,
- undiagnosed genital bleeding,
- venous or arterial history or presence of thromboembolism,
- cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17ß-Estradiol/Dydrogesterone1/5 mg/day for 12 cycles of 28 days | Drug | 1 |
| Tibolone2,5 mg/day for 12 cycles of 28 days | Drug | 2 |
Primary outcome
IGF1 values after 12 cycles of 28 days
Time frame: 1 year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 17ß-Estradiol/Dydrogesterone and Tibolone in people with Menopause, run by Solvay Pharmaceuticals at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGF1 values after 12 cycles of 28 days (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2009.