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Effects of tibolone and continuous combined hormone replacement therapy on bleeding rates, quality of life and tolerability in postmenopausal women

  1. J. Huber1,*,
  2. S. Palacios2,
  3. L. Berglund3,
  4. W. Hänggi4,
  5. S.M. Sathanandan5,
  6. S. Christau6,
  7. F. Helmond7

Article first published online: 22 DEC 2003

DOI: 10.1111/j.1471-0528.2002.01338.x

Issue

BJOG: An International Journal of Obstetrics & Gynaecology

BJOG: An International Journal of Obstetrics & Gynaecology

Volume 109, Issue 8, pages 886–893, August 2002

Additional Information

How to Cite

Huber, J., Palacios, S., Berglund, L., Hänggi, W., Sathanandan, S.M., Christau, S. and Helmond, F. (2002), Effects of tibolone and continuous combined hormone replacement therapy on bleeding rates, quality of life and tolerability in postmenopausal women. BJOG: An International Journal of Obstetrics & Gynaecology, 109: 886–893. doi: 10.1111/j.1471-0528.2002.01338.x

Author Information

  1. 1

    Menox Institute, Vienna, Austria

  2. 2

    Palacios Institute of Women's Health, Madrid, Spain

  3. 3

    Department of Obstetrics and Gynecology, County Hospital, Sundsvall, Sweden

  4. 4

    Department of Obstetrics and Gynecology, University of Bern, Bern, Switzerland

  5. 5

    Department of Obstetrics and Gynaecology, Harold Wood Hospital, Romford, UK

  6. 6

    Frederikdalsvej 70, Virum, Denmark

  7. 7

    NV Organon, Oss, The Netherlands

**Professor Dr J. Huber, I. Universitatsfrauenklinik, Division of Obstetrics and Gynecology, Waehringerguertel 18–20, A-1090 Vienna, Austria.

Publication History

  1. Issue published online: 22 DEC 2003
  2. Article first published online: 22 DEC 2003
  3. Accepted 17 April 2002

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Objective To compare the effects of tibolone and conjugated equine oestrogens continuously combined with medroxyprogesterone acetate on bleeding rates, quality of life (QoL) and tolerability.

Design A double-blind, randomised comparative trial.

Setting Thirty-seven centres in six European countries.

Population Five hundred and one postmenopausal women, under 65 years of age with an intact uterus.

Interventions For 12 months, women received daily treatment with tibolone 2.5 mg (n= 250), or conjugated equine oestrogens 0.625 mg continuously combined with medroxyprogesterone acetate 5 mg (CEE–MPA, n= 251).

Main outcome measures The primary outcome was vaginal bleeding rate during cycles 4–6. The secondary outcomes were vaginal bleeding rate during cycles 1–3, 7–9 and 10–13, cumulative bleeding rate, QoL, wellbeing, climacteric symptoms, urogenital complaints and tolerability.

Results Treatment with tibolone led to a significantly lower bleeding rate during cycles 4–6 compared with CEE–MPA (15.0%vs 26.9%; P= 0.004); there was a similar difference during cycles 1–3. Both treatments improved QoL, wellbeing, climacteric symptoms and urogenital complaints. By intent-to-treat analysis, tibolone significantly improved sexual drive, interest and/or performance, compared with CEE–MPA at 12 months (P= 0.017). Although both treatments were well tolerated, there was a significantly lower incidence of breast tenderness with tibolone than CEE–MPA (2.4%vs 17.1%; P < 0.001).

Conclusion The vaginal bleeding rate during cycles 4–6 was significantly lower in women using tibolone. Both treatments improved QoL, wellbeing, climacteric symptoms and urogenital symptoms. Breast tenderness was significantly less frequent with tibolone.

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