RaloxifeneNCT04454775
Raloxifene on Coagulation System in the Postmenopausal Women
An observational study of Raloxifene and Postmenopausal Women, run by Karadeniz Technical University.
Trial summary
Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation parameters in healthy postmenopausal women. Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical University Hospital at gynecology out-patient clinic from December 2005 to December 2006. Read more about this study
- Who is it for?
- Ages 42 to 62 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Raloxifene, Postmenopausal Women
- What is being tested?
- coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2005to 20 Dec 2006
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 42 to 62 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who applied to Menopause outpatient clinic with the approval of Karadeniz Technical University Faculty of Medicine Ethics Committee numbered 2005/47 were evaluated within the scope of the prospective study. Working time was determined as 12 months.
Who may be able to join
- In the study planned on patients who have not had menstruation for at least one year, or who have been in menopause naturally or surgically,
- the presence of menopause was accepted if the patients' FSH level was> 40 IU / L. Verbal and written consent was obtained from all patients included in the study.
Who cannot join
- . Hypertension,
- diabetes mellitus,
- hypercholesterolemia,
- presence of hepatic-renal-thyroid-parathyroid-adrenal diseases,
- cardiovascular,
- cerebrovascular and thromboembolic diseases,
Show all 12Show fewer
- undiagnosed vaginal bleeding,
- presence of hormone-dependent malignancy or anamnesis,
- presence of varicose veins,
- chronic drug use that disrupts sex steroid metabolism
- cases with smoking
- alcohol use
About this study
Official title: The Effect of Raloxifene on the Parameters of Coagulation System in the Postmenopausal Women
Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation parameters in healthy postmenopausal women.
Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical University Hospital at gynecology out-patient clinic from December 2005 to December 2006. Local institutional ethics committee approved our study protocol and written informed consent was obtained from all participants before enrollment. All patients received daily 600 milligrams of calcium and 400 international units of vitamin D (Cal-D-VİTA, Roche Switzerland,). 60 milligrams of raloxifene HCI, which is a selective estrogen receptor modulator (SERM), was added to treatment protocol if patients required hormonal therapy. Patients receiving raloxifene therapy in addition to calcium and vitamin D therapy formed the study group(n=50). Control group (n=30) was made up of the patients only receiving calcium and vitamin D. Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III and fibrinogen levels were measured in all patients before treatment. These measurements were repeated at three and twelve months after treatment. Comparisons were performed with Student t test or Mann Whitney test between the two groups and two-way ANOVA within the groups. Proportions were compared with Fisher exact or Chi-square tests. Statistically analysis was done with SPSS packet program (SPSS 11; SPSS Inc.) All p values were two-tailed and p<0.05 was considered statistically significant.
- Conditions
- Raloxifene, Postmenopausal Women
- Being tested
- coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.
- Keywords
- raloxifene, coagulation system, von Willebrand factor, Factor 8, vitamin D, protein C, protein S, antithrombin- III, fibrinogen
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| group I | 50 cases who received raloxifene and calcium therapy Receives: Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied. | |
| group II | 30 cases who received only calcium therapy Receives: Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring coagulation parametres
After collecting all blood, Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III, and fibrinogen levels were measured in all patients.
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 posted1 Jul 2020
- Study start1 Dec 2005
- Primary completion1 Dec 2006
- Study completion20 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RaloxifeneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Guven, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454775
- Sponsor's protocol ID
- 2005/47
- Status last verified
- Jul 2020
- First submitted
- 5 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Raloxifene on the Parameters of Coagulation System in the Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04454775
- Acronym / sponsor ID
- 2005/47
- Conditions
- Raloxifene, Postmenopausal Women
- Keywords
- raloxifene, coagulation system, von Willebrand factor, Factor 8, vitamin D, protein C, protein S, antithrombin- III
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2005 (actual)
- Primary completion
- 1 Dec 2006 (actual)
- Study completion
- 20 Dec 2006 (actual)
- First posted
- 1 Jul 2020 (actual)
- 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.
Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation parameters in healthy postmenopausal women.
Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical University Hospital at gynecology out-patient clinic from December 2005 to December 2006. Local institutional ethics committee approved our study protocol and written informed consent was obtained from all participants before enrollment. All patients received daily 600 milligrams of calcium and 400 international units of vitamin D (Cal-D-VİTA, Roche Switzerland,). 60 milligrams of raloxifene HCI, which is a selective estrogen receptor modulator (SERM), was added to treatment protocol if patients required hormonal therapy. Patients receiving raloxifene therapy in addition to calcium and vitamin D therapy formed the study group(n=50). Control group (n=30) was made up of the patients only receiving calcium and vitamin D. Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III and fibrinogen levels were measured in all patients before treatment. These measurements were repeated at three and twelve months after treatment. Comparisons were performed with Student t test or Mann Whitney test between the two groups and two-way ANOVA within the groups. Proportions were compared with Fisher exact or Chi-square tests. Statistically analysis was done with SPSS packet program (SPSS 11; SPSS Inc.) All p values were two-tailed and p<0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | – | Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.50 cases who received raloxifene and calcium therapy |
| group II | – | Diagnostic Test: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.30 cases who received only calcium therapy |
Who may qualify
- Ages
- 42 to 62 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who applied to Menopause outpatient clinic with the approval of Karadeniz Technical University Faculty of Medicine Ethics Committee numbered 2005/47 were evaluated within the scope of the prospective study. Working time was determined as 12 months.
Key inclusion criteria (2 listed)
- In the study planned on patients who have not had menstruation for at least one year, or who have been in menopause naturally or surgically,
- the presence of menopause was accepted if the patients' FSH level was> 40 IU / L. Verbal and written consent was obtained from all patients included in the study.
Key exclusion criteria (12 listed)
- . Hypertension,
- diabetes mellitus,
- hypercholesterolemia,
- presence of hepatic-renal-thyroid-parathyroid-adrenal diseases,
- cardiovascular,
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 |
|---|---|---|
| coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied. | Diagnostic test | group I, group II |
Primary outcome
Measuring coagulation parametres
Time frame: 1 year
After collecting all blood, Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III, and fibrinogen levels were measured in all patients.
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 7 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Raloxifene and Postmenopausal Women, run by Karadeniz Technical University.
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 12 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Measuring coagulation parametres (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 7 Jul 2020.