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

Abstract

UNLABELLED:

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.

STUDY DESIGN:

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.

CONCLUSION:

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.

• Authors: Diana Cieraad, Christian Conradt, Diana Jesinger, Marie Bakowski
• Journal: Archives of gynecology and obstetrics (Arch Gynecol Obstet) Vol. 274 Issue 2 Pg. 74-80 (May 2006) ISSN: 0932-0067 [Print] Germany
• PMID: 16491367 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Cholesterol, HDL
• Estrogens, Conjugated (USP)
• Norgestrel
• Estradiol
• Dydrogesterone

Topics

• Cholesterol, HDL (blood, drug effects)
• Double-Blind Method
• Drug Therapy, Combination
• Dydrogesterone (pharmacology, therapeutic use)
• Estradiol (pharmacology, therapeutic use)
• Estrogen Replacement Therapy
• Estrogens, Conjugated (USP) (pharmacology, therapeutic use)
• Female
• Hot Flashes (drug therapy)
• Humans
• Middle Aged
• Norgestrel (pharmacology, therapeutic use)
• Perimenopause (drug effects)
• Postmenopause (drug effects)
• Prospective Studies
• Vasomotor System (drug effects)