Raloxifene on Coagulation System in the Postmenopausal Women

Postmenopausal Women Clinical Trial

Official title:

The Effect of Raloxifene on the Parameters of Coagulation System in the Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454775
• Other study ID #: 2005/47
• Status: Completed
• Start date: December 1, 2005
• Est. completion date: December 20, 2006

Study information

• Verified date: July 2020
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 20, 2006
• Est. primary completion date: December 1, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Postmenopausal Women
• Raloxifene

Intervention

Diagnostic Test:
• coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year