Clinical study comparing the effects of sequential hormone replacement therapy with oestradiol/dydrogesterone and conjugated equine oestrogen/norgestrel on lipids and symptoms.
A clinical study comparing the effects of sequential hormone replacement therapy with oestradiol/dydrogesterone and conjugated equine oestrogen/norgestrel on lipids and symptoms.


OBJECTIVE
The objective of the study was to compare the effects of sequential 17beta-oestradiol/dydrogesterone and conjugated equine oestrogens (CEE)/norgestrel on lipid parameters, climacteric symptoms, bleeding patterns and tolerability.


METHODS
This double-blind study was conducted in 193 peri- and post-menopausal women randomised to receive six, 28-day cycles of oral sequential oestradiol 1 mg/dydrogesterone 10 mg or CEE 0.625 mg/norgestrel 0.15 mg. The change from baseline in serum lipids and hot flushes was analysed using a two-way analysis of variance.


RESULTS
After 24 weeks there was a statistically significant increase in high-density lipoprotein (HDL) cholesterol in the oestradiol/dydrogesterone group and a significant reduction in the CEE/norgestrel group. The difference between the groups was significant (P=0.001). The number of hot flushes was reduced by 86% in both groups; this improvement was supported by the Greene Climacteric Symptom Scale score, the patients' opinion and quality of life assessments. The percentage of women experiencing cyclic bleeding was greater with CEE/norgestrel, as was the mean duration and severity of bleeding. Both treatments were well tolerated.


CONCLUSIONS
Oestradiol/dydrogesterone and CEE/norgestrel were equally effective in treating climacteric symptoms, but oestradiol/dydrogesterone showed some advantages in terms of lipid profile and incidence of bleeding.
Solvay Pharmaceuticals BV, Weesp, The Netherlands.
Diana
D
Cieraad
Christian
C
Conradt
Diana
D
Jesinger
Marie
M
Bakowski
D008076:Cholesterol, HDL / Q000097:blood / Q000187:drug effects*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004394:Dydrogesterone / Q000494:pharmacology / Q000627:therapeutic use*; D004958:Estradiol / Q000494:pharmacology / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D004966:Estrogens, Conjugated (USP) / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D009644:Norgestrel / Q000494:pharmacology / Q000627:therapeutic use*; D047648:Perimenopause / Q000187:drug effects; D017698:Postmenopause / Q000187:drug effects; D011446:Prospective Studies; D014666:Vasomotor System / Q000187:drug effects
D008076:Cholesterol, HDL; D004966:Estrogens, Conjugated (USP); D009644:Norgestrel; D004958:Estradiol; D004394:Dydrogesterone