Efficacy, tolerability, and rare side effects of tibolone treatment in postmenopausal women

Int J Gynaecol Obstet. 1999 Mar;64(3):281-6. doi: 10.1016/s0020-7292(99)00002-8.

Abstract

Objective: The purpose of this study was to assess the tolerability and side effects of tibolone (Livial, Organon), a synthetic steroid analogue for the treatment of postmenopausal symptoms, in a large population of patients.

Method: 1189 postmenopausal patients were included in this study. The patients' blood pressure, body weight, general complaints, and the severity of their climacteric complaints were documented at baseline and after 4 months of tibolone treatment.

Results: Tibolone significantly relieved all of the classical menopausal complaints. The proportion of patients with bleeding problems dropped significantly from 15.9% to 6.8%. Other complaints, such as headache, vertigo, nervousness, breast tenderness, and hirsutism were also significantly less frequent than before treatment. Only few women reported other rare side effects, and only 14.4% of women discontinued treatment prematurely.

Conclusion: Tibolone provides an efficient and safe means of treating the postmenopausal syndrome in every-day practice.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Agents, Hormonal / adverse effects
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Female
  • Hormone Replacement Therapy*
  • Humans
  • Middle Aged
  • Norpregnenes / adverse effects
  • Norpregnenes / therapeutic use*
  • Postmenopause
  • Prospective Studies

Substances

  • Antineoplastic Agents, Hormonal
  • Norpregnenes
  • tibolone