CompletedNot Applicable

Raloxifene on Coagulation System in the Postmenopausal Women

80 participantsStarted 2005-12-01

Plain-language 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. 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.

Who can participate

Age range

42 Years – 62 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * . Hypertension, * diabetes mellitus, * hypercholesterolemia, * presence of hepatic-renal-thyroid-parathyroid-adrenal diseases, * cardiovascular, * cerebrovascular and thromboembolic diseases, * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measuring coagulation parametres

Timeframe: 1 year

Trial details

NCT IDNCT04454775

SponsorKaradeniz Technical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2006-12-01

View on ClinicalTrials.gov More Raloxifene trials