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Hum. Reprod. Advance Access published online on May 19, 2005

Human Reproduction, doi:10.1093/humrep/dei085
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© The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org
Received November 2, 2004
Revised April 16, 2005
Accepted April 19, 2005

Article

Levonorgestrel intrauterine system (LNG-IUS) with conjugated oral equine estrogen: a successful regimen for HRT in perimenopausal women

N.R.E. Hampton 1*, M.C.P. Rees 2, D.G. Lowe 3, I. Rauramo 4, D. Barlow 2, and J. Guillebaud 1

1 Research Unit, Margaret Pyke Centre, 73 Charlotte Street, London W1T 4PL, UK
2 Women's Centre, John Radcliffe Hospital, Oxford OX3 9DU, UK
3 Department of Histopathology, St Bartholomew's Hospital, West Smithfield, London EC1A 7BE, UK and
4 The Finnish Medical Society Duodecim, Kalevankatu 11A, P.O.Box 713, 00101 Helsinki, Finland

* To whom correspondence should be addressed.
N.R.E. Hampton, E-mail: naomi.hampton{at}ealingpct.nhs.uk


   Abstract

BACKGROUND: This study was designed to assess the long-term efficacy (5 years) of the levonorgestrel-releasing intrauterine system (LNG-IUS) in protecting the endometrium from hyperplasia during estrogen replacement therapy in perimenopausal women. METHODS: Prospective, open, outpatient clinical trial in London and Oxford. Eighty-two women received oral conjugated equine estrogen 1.25 mg daily and LNG-IUS releasing 20 µg levonorgestrel per 24 h. Endometrial biopsy and histological assessment were performed annually. Endometrial thickness was measured by vaginal ultrasonography. RESULTS: Non-proliferative endometrium was present at the end of cycles 12, 24, 36, 48 and 60 in 98.6, 98.6, 95.5, 96.8 and 95.2% of the participants respectively. No endometrial hyperplasias were confirmed throughout a period of 60 cycles. The proportion of amenorrhoeic women increased from 54.4% at 12 cycles to 92.7% at the end of the study. The continuation rate per 100 women at 60 cycles was 79.84 (95% CI 71.0-88.6). CONCLUSIONS: The LNG-IUS with estrogen supplementation in perimenopausal women suppresses endometrial proliferation resulting in amenorrhoea and relieves vasomotor symptoms. The treatment regimen is well tolerated and provides an alternative strategy for perimenopausal women with the likelihood of increasing compliance.

Keywords: bleeding/endometrium/hyperplasia/LNG-IUS/perimenopause.
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