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NCT04454775
Raloxifene on Coagulation System in the Postmenopausal Women
trial testing coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied. in Raloxifene in 80 participants. Completed in 20 December 2006.
1 December 2006
Quick facts
| Lead sponsor | Karadeniz Technical University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 1 December 2005 |
| Primary completion | 1 December 2006 |
| Estimated completion | 20 December 2006 |
Drugs / interventions tested
- coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.
Conditions studied
- Raloxifene — all drugs for Raloxifene →
- Postmenopausal Women — all drugs for Postmenopausal Women →
Sponsor
Karadeniz Technical University
Who can join
Adults 42 to 62, female only, with Raloxifene or Postmenopausal Women. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04454775 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karadeniz Technical University
- Last refreshed: 7 July 2020
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