| A comparative study of two hormone replacement therapy regimens on safety and efficacy variables. | |
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MedLine Citation:
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PMID: 7616869 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To assess the effect of tibolone on endometrial safety, plasma estradiol concentrations, lipid metabolism and climacteric symptoms in comparison to sequential conjugated equine estrogens and medroxyprogesterone acetate in postmenopausal women. METHODS: In a randomised, open-label, 6-cycle, group-comparative study, the effects on the aforementioned parameters were studied with tibolone 2.5 mg/day (N = 13) continuously, and with conjugated equine estrogens 0.625 mg/day continuously, combined with medroxyprogesterone acetate 5 mg/day (N = 11) (CEE/MPA) sequentially, during 12 days of each 28-day cycle. Within-group statistical analysis was performed with Student's t-test for paired samples, whereas between-group statistics were performed using the Student's t-test for independent groups. RESULTS: Cytological evaluation revealed no endometrial stimulation in either group. In the tibolone group, there were no effects on estradiol levels, whereas in the CEE/MPA group, an increase in total and non-SHBG-bound estradiol plasma levels was reported. In the tibolone group, there were significant decreases in plasma total cholesterol, triglycerides, HDL-cholesterol and VLDL-cholesterol, whereas no significant changes in LDL-cholesterol and IDL-cholesterol were reported. In the CEE/MPA group there were significant decreases in plasma total cholesterol, HDL-cholesterol and LDL-cholesterol, whereas there were no significant changes in triglycerides, IDL-cholesterol and VLDL-cholesterol. Climacteric symptoms, particularly vasomotor episodes, decreased similarly in both groups. CONCLUSIONS: Both tibolone and CEE/MPA were safe with respect to effects on the endometrium and both treatments induced changes in the plasma profiles of certain lipid and lipoprotein parameters. However, the overall clinical implications of these changes are unknown. Finally, both regimens were equally effective in the treatment of climacteric symptoms. |
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Authors:
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N O Siseles; H Halperin; H J Benencia; G Berg; S Pilnik; V Mesch; B Arrighi; R W Wikinski |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Maturitas Volume: 21 ISSN: 0378-5122 ISO Abbreviation: Maturitas Publication Date: 1995 Apr |
Date Detail:
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Created Date: 1995-08-18 Completed Date: 1995-08-18 Revised Date: 2009-11-19 |
Medline Journal Info:
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Nlm Unique ID: 7807333 Medline TA: Maturitas Country: IRELAND |
Other Details:
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Languages: eng Pagination: 201-10 Citation Subset: IM |
Affiliation:
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Climacteric Section, Hospital Italiano, Buenos Aires, Argentina. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anabolic Agents
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administration & dosage,
adverse effects Cervix Uteri / cytology, drug effects Endometrium / cytology, drug effects Estradiol / blood Estrogen Replacement Therapy* / adverse effects Estrogens, Conjugated (USP) / administration & dosage*, adverse effects Female Humans Lipids / blood Lipoproteins / blood Medroxyprogesterone Acetate / administration & dosage*, adverse effects Middle Aged Norpregnenes / administration & dosage*, adverse effects Postmenopause / blood Vagina / cytology, drug effects |
| Chemical | |
Reg. No./Substance:
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0/Anabolic Agents; 0/Estrogens, Conjugated (USP); 0/Lipids; 0/Lipoproteins; 0/Norpregnenes; 50-28-2/Estradiol; 5630-53-5/tibolone; 71-58-9/Medroxyprogesterone Acetate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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