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

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 tri...

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Published in:	Human reproduction (Oxford) Vol. 20; no. 9; pp. 2653 - 2660
Main Authors:	Hampton, N.R.E., Rees, M.C.P., Lowe, D.G., Rauramo, I., Barlow, D., Guillebaud, J.
Format:	Journal Article
Language:	English
Published:	Oxford Oxford University Press 01-09-2005 Oxford Publishing Limited (England)
Subjects:	Administration, Oral Adult Animals Biological and medical sciences Birth control bleeding/endometrium/hyperplasia/LNG-IUS/perimenopause Contraceptive Agents, Female - administration & dosage Contraceptive Agents, Female - adverse effects Endometrial Hyperplasia - drug therapy Endometrial Hyperplasia - prevention & control Estrogen Replacement Therapy - adverse effects Estrogen Replacement Therapy - methods Estrogens - administration & dosage Estrogens - adverse effects Female Gynecology. Andrology. Obstetrics Hormonal contraception Horses Humans Levonorgestrel - administration & dosage Levonorgestrel - adverse effects Medical sciences Middle Aged Perimenopause Prospective Studies Treatment Outcome Uterine Hemorrhage - drug therapy Uterine Hemorrhage - prevention & control bleeding/endometrium/hyperplasia/LNG-IUS/perimenopause Human Intrauterine administration Hyperplasia Menopause Levonorgestrel Estrogen Oral administration Hemorrhage Ovarian hormone Progestagen Uterus Animal Female genital system Female Perimenopause Contraceptive Hormone replacement therapy Sex steroid hormone Therapeutic protocol Endometrium
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Summary:	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.
Bibliography:	href:dei085.pdf local:dei085 ark:/67375/HXZ-C4L53B6W-L 5To whom correspondence should be addressed. Email: naomi.hampton@ealingpct.nhs.uk istex:B22D9184FBF5C4557C6977FB88D3A78B7F86BE18
ISSN:	0268-1161 1460-2350
DOI:	10.1093/humrep/dei085