NCT04454775

Raloxifene on Coagulation System in the Postmenopausal Women

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Karadeniz Technical University · Academic / Other
• Sex: Female
• Age: 42 Years – 62 Years
• Healthy volunteers: Accepted

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.

Conditions

• Raloxifene
• Postmenopausal Women

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-12-01
• Completion: 2006-12-20
• First posted: 2020-07-01
• Last updated: 2020-07-07