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PJ Online homeThe Pharmaceutical Journal
Vol 273 No 7316 p340
11 September 2004

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Leptin injection may be useful in amenorrhoea

Injection of recombinant human leptin has successfully treated hypothalamic amenorrhoea in a recent, small US study.

Hypothalamic amenorrhoea occurs typically in athletes or underweight women. Leptin is the hormone thought to be linked to the suppression of reproductive function in such women in response to low energy stores.

Researchers from Harvard Medical School studied eight women with hypothalamic amenorrhoea for one month before and three months after treatment with recombinant human leptin. The women self-administered the subcutaneous injection at a dose of 0.08mg/kg/day: 40 per cent of the dose was given at 8am and 60 per cent at 8pm to mimic normal diurnal leptin levels. Five of the eight subjects, whose periods had stopped a mean of five years beforehand, went on to start menstruating. In three of these women ovulation occurred and, in the other two, preovulatory follicles developed.

Leptin administration increased the levels of reproductive, thyroid and growth hormones without apparent adverse effects. The authors of the study say that the current treatment of hypothalamic amenorrhoea, oestrogen, may have side effects and does not address underlying infertility. They add that further studies are warranted to determine the safety and efficacy of this agent (New England Journal of Medicine 2004;351:987).

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