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

Abstract

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.

• Authors: J Huber, S Palacios, L Berglund, W Hänggi, S M Sathanandan, S Christau, F Helmond
• Journal: BJOG : an international journal of obstetrics and gynaecology (BJOG) Vol. 109 Issue 8 Pg. 886-93 (Aug 2002) ISSN: 1470-0328 [Print] England
• PMID: 12197367 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Drug Combinations
• Estrogen Receptor Modulators
• Estrogens
• Norpregnenes
• tibolone
• Medroxyprogesterone

Topics

• Drug Combinations
• Estrogen Receptor Modulators (administration & dosage)
• Estrogens (administration & dosage)
• Female
• Hormone Replacement Therapy (methods)
• Humans
• Medroxyprogesterone (administration & dosage)
• Middle Aged
• Norpregnenes (administration & dosage)
• Quality of Life
• Uterine Hemorrhage (prevention & control)