Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract, and tolerability in postmenopausal women

Janne Komi, Kari S. Lankinen, Pirkko Härkönen, Michael W. DeGregorio, Sari Voipio, Seppo Kivinen, Risto Tuimala, Tarja Vihtamäki, Kimmo Vihko, Olavi Ylikorkala, Risto Erkkola

Research output: Contribution to journalArticle

80 Citations (Scopus)

Abstract

Objective: To compare ospemifene and raloxifene regarding their effects on hormones, lipids, genital tract, and tolerability in postmenopausal women. Design: A randomized, double-blind study in which 118 healthy postmenopausal women received 30 (n = 29), 60 (n = 30), or 90 mg (n = 30) of ospemifene or 60 mg (n = 29) of raloxifene for 3 months. Results: There were no significant differences in the baseline characteristics between study groups. In comparison with raloxifene, follicle-stimulating hormone levels decreased significantly more in the 90-mg ospemifene group and sex hormone-binding globulin levels increased more in all ospemifene groups. Total cholesterol and low-density lipoprotein cholesterol levels decreased more in raloxifene than in ospemifene groups, although the difference in low-density lipoprotein cholesterol between 90-mg ospemifene and raloxifene was not significant. Endometrial thickness did not change in any study group and endometrial biopsies showed atrophy in the majority of subjects at 3 months. All ospemifene groups demonstrated a clear estrogenic effect on the vaginal epithelium, as seen in Pap smears. This was in sharp contrast to the raloxifene group, which had no effect on the vaginal epithelium. Kupperman index decreased in all study groups during treatment. The adverse events were mild, mainly single cases, and no clustering of events was observed. There were no clinically significant abnormal findings in laboratory safety parameters. Conclusions: Ospemifene, at the dose of 90 mg/day, was more estrogenic than raloxifene, as shown by changes in serum follicle-stimulating hormone and sex hormone-binding globulin levels. Neither agent stimulated endometrium, but in contrast to raloxifene, ospemifene had a clear estrogenic effect in the vagina. Further studies with ospemifene are needed in subjects with vaginal atrophy.

Original languageEnglish (US)
Pages (from-to)202-209
Number of pages8
JournalMenopause
Volume12
Issue number2
DOIs
StatePublished - 2005

Fingerprint

Lipids
Sex Hormone-Binding Globulin
Follicle Stimulating Hormone
LDL Cholesterol
Atrophy
Estrogens
Epithelium
Raloxifene Hydrochloride
Ospemifene
Papanicolaou Test
Vagina
Endometrium
Double-Blind Method
Cluster Analysis
Cholesterol
Hormones
Biopsy
Safety
Serum

Keywords

  • Ospemifene
  • Postmenopausal
  • Raloxifene
  • Selective estrogen receptor modulators
  • Vaginal atrophy

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Komi, J., Lankinen, K. S., Härkönen, P., DeGregorio, M. W., Voipio, S., Kivinen, S., ... Erkkola, R. (2005). Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract, and tolerability in postmenopausal women. Menopause, 12(2), 202-209. https://doi.org/10.1097/00042192-200512020-00015

Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract, and tolerability in postmenopausal women. / Komi, Janne; Lankinen, Kari S.; Härkönen, Pirkko; DeGregorio, Michael W.; Voipio, Sari; Kivinen, Seppo; Tuimala, Risto; Vihtamäki, Tarja; Vihko, Kimmo; Ylikorkala, Olavi; Erkkola, Risto.

In: Menopause, Vol. 12, No. 2, 2005, p. 202-209.

Research output: Contribution to journalArticle

Komi, J, Lankinen, KS, Härkönen, P, DeGregorio, MW, Voipio, S, Kivinen, S, Tuimala, R, Vihtamäki, T, Vihko, K, Ylikorkala, O & Erkkola, R 2005, 'Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract, and tolerability in postmenopausal women', Menopause, vol. 12, no. 2, pp. 202-209. https://doi.org/10.1097/00042192-200512020-00015
Komi, Janne ; Lankinen, Kari S. ; Härkönen, Pirkko ; DeGregorio, Michael W. ; Voipio, Sari ; Kivinen, Seppo ; Tuimala, Risto ; Vihtamäki, Tarja ; Vihko, Kimmo ; Ylikorkala, Olavi ; Erkkola, Risto. / Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract, and tolerability in postmenopausal women. In: Menopause. 2005 ; Vol. 12, No. 2. pp. 202-209.
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AU - Härkönen, Pirkko

AU - DeGregorio, Michael W.

AU - Voipio, Sari

AU - Kivinen, Seppo

AU - Tuimala, Risto

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