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Abstract
Forty-five healthy postmenopausal women participated in a study designed to examine
the effects on bone and mineral metabolism of SHD 386L, a new hormone replacement
therapy (HRT) regime. This oral preparation delivers 2 mg estradiol valerate daily
and 75 μg of levonorgestrel from days 17–28 inclusive of a 28-day cycle. The study
was double-blind, randomized and placebo controlled. Patients who received SHD 386L
exhibited significant falls in plasma calcium, ionised calcium, phosphate and total
alkaline phosphatase. No alteration, however, was observed in plasma osteocalcin.
No significant changes in mineral metabolism were observed in a parallel group receiving
levonorgestrel alone. The results indicate that SHD 386L is likely to be protective
to the skeleton through inhibition of bone resorption and that such actions are attributable
to the estrogen component. The preparation was well tolerated, compliance was satisfactory
and serious adverse affects were not seen. The above biochemical evidence for skeletal
protection will require to be supplemented by prospective biophysical evidence of
the effect of SHD 386L on bone mineral density.
Keywords
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Article info
Publication history
Accepted:
November 23,
1991
Received in revised form:
November 14,
1991
Received:
October 9,
1990
Identification
Copyright
© 1992 Published by Elsevier Inc.
