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 trial in London and Oxford. Eighty-two women received oral conjugated equine estrogen 1.25 mg daily and LNG-IUS releasing 20 mug 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.
Hampton
N R E
NR
Research Unit, Margaret Pyke Centre, London, UK. naomi.hampton@ealingpct.nhs.uk
Rees
M C P
MC
Lowe
D G
DG
Rauramo
I
I
Barlow
D
D
Guillebaud
J
J
D000284:Administration, Oral; D000328:Adult; D000818:Animals; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D004714:Endometrial Hyperplasia / Q000188:drug therapy / Q000517:prevention & control*; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006736:Horses; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D047648:Perimenopause; D011446:Prospective Studies; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000188:drug therapy / Q000517:prevention & control
D003271:Contraceptive Agents, Female; D004967:Estrogens; D016912:Levonorgestrel