Effect of continuous administration of conjugated estrogen plus medroxyprogesterone acetate (Premelle) in postmenopausal women in Taiwan.
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.
Yang
Tzay-Shing
TS
Department of Obstetrics and Gynecology, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC. chenyj@vghtpe.gov.tw
Wang
Huai-Ling
HL
Chen
Yi-Jen
YJ
Chang
Sheng-Ping
SP
Yuan
Chiou-Chung
CC
D008076:Cholesterol, HDL / Q000097:blood / Q000187:drug effects; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D004311:Double-Blind Method; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008525:Medroxyprogesterone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008593:Menopause / Q000187:drug effects; D008875:Middle Aged; D010045:Outpatients; D010612:Pharyngitis / Q000139:chemically induced; D017698:Postmenopause / Q000097:blood / Q000187:drug effects*; D012725:Sexual Behavior / Q000187:drug effects; D013624:Taiwan; D013997:Time Factors; D014280:Triglycerides / Q000097:blood
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D014280:Triglycerides; D008525:Medroxyprogesterone