Document Detail


Effect of continuous administration of conjugated estrogen plus medroxyprogesterone acetate (Premelle) in postmenopausal women in Taiwan.
MedLine Citation:
PMID:  15510930     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: To compare the metabolic effects on lipids and acceptability and safety of, and compliance with, a continuous administration of conjugated estrogen plus medroxyprogesterone acetate (Premelle) versus a placebo in non-hysterectomized postmenopausal women. METHODS: Sixty-six generally healthy, female, early post-menopausal women, from 45-60 years of age, were randomized for an administration of conjugated estrogen plus medroxyprogesterone acetate (Premelle, Premarin 0.625 mg plus medroxyprogesterone acetate 2.5 mg/tablet orally) or a placebo for 6 months. The changes in each patient's lipid profiles from baseline, the frequency of hot flushes, bleeding occurrences, and climacteric symptoms, were evaluated. Safety was monitored by means of physical examination, Papanicolau smear, transvaginal ultrasonography, and laboratory check-up. Adverse events were also recorded. RESULTS: The difference before and after treatment in serum LDL-C and total cholesterol (TC) was statistically significant in the Premelle group (LDL-C, p = 0.006, TC, p = 0.040). No statistically significant difference in the change from baseline was observed in the levels of LDL-C and TC in the placebo treatment group. There was a statistically significant change from baseline in menopausal symptoms, which were evaluated by the Greene Climacteric Scales in the Premelle group. There was no clinically significant finding in the physical examination, vital signs, laboratory data, or endometrial thickness in either treatment group. The difference in the number of patients who reported an adverse event was not statistically significant between the 2 treatment groups. CONCLUSIONS: This study demonstrated that Premelle was effective in decreasing LDL-C and total cholesterol levels, and also showed an improvement in some menopausal symptoms, such as vasomotor and sexual dysfunction symptoms. No significant bleeding was observed with Premelle, which was well tolerated in this study. The results of this study could support the use of Premelle tablets as a convenient alternative hormone therapy.
Authors:
Tzay-Shing Yang; Huai-Ling Wang; Yi-Jen Chen; Sheng-Ping Chang; Chiou-Chung Yuan
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of the Chinese Medical Association : JCMA     Volume:  67     ISSN:  1726-4901     ISO Abbreviation:  J Chin Med Assoc     Publication Date:  2004 Jul 
Date Detail:
Created Date:  2004-10-29     Completed Date:  2005-01-05     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  101174817     Medline TA:  J Chin Med Assoc     Country:  China (Republic: 1949- )    
Other Details:
Languages:  eng     Pagination:  336-43     Citation Subset:  IM    
Affiliation:
Department of Obstetrics and Gynecology, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC. chenyj@vghtpe.gov.tw
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MeSH Terms
Descriptor/Qualifier:
Cholesterol, HDL / blood,  drug effects
Cholesterol, LDL / blood,  drug effects
Contraceptives, Oral, Synthetic / administration & dosage,  adverse effects,  pharmacology
Double-Blind Method
Estrogens / administration & dosage,  adverse effects,  pharmacology
Estrogens, Conjugated (USP) / administration & dosage,  adverse effects,  pharmacology*
Female
Follow-Up Studies
Humans
Medroxyprogesterone / administration & dosage,  adverse effects,  pharmacology*
Menopause / drug effects
Middle Aged
Outpatients
Pharyngitis / chemically induced
Postmenopause / blood,  drug effects*
Sexual Behavior / drug effects
Taiwan
Time Factors
Triglycerides / blood
Chemical
Reg. No./Substance:
0/Cholesterol, HDL; 0/Cholesterol, LDL; 0/Contraceptives, Oral, Synthetic; 0/Estrogens; 0/Estrogens, Conjugated (USP); 0/Triglycerides; 520-85-4/Medroxyprogesterone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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