Gynecologie, obstetrique & fertilite · 2005
[The antigonadrotropic activity of chlormadinone acetate in reproductive women].
Клиническое исследованиеАннотация на английскомСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Chassard D, Schatz B
Аннотация
INTRODUCTION: Progesterone modulates pulsatile secretion of LH throughout the normal menstrual cycle in women. This effect is observed essentially at hypothalamic level via progesterone receptors, with a decline in frequency of GnRH cyclic secretion. It was observed that when several nor-progesterone and nor-testosterone derived progestins were administered, the antigonadotropic function of the hypothalamic-pituitary-ovarian axis was inhibited.
OBJECTIVE: Determine chlormadinone acetate's antigonadotropic activity when administered according to two schemes: from the day 5 to day 25 (L5) and from day 8 to day 25 (L8) of the menstrual cycle.
PATIENTS AND METHODS: Randomized monocentric study carried out in twenty normally cycling healthy women included in two parallel groups and receiving 10 mg of chlormadinone acetate once a day, either from day 5 to day 25, or from day 8 to day 25 of the menstrual cycle. Hormonal dosages were determined with blood samplings performed each day from day 5 to day 25 of each menstrual cycle for estradiol, FSH and LH and from day 14 to day 25 of each cycle for progesterone.
RESULTS: Sixteen women in group L5 and 14 in group L8 were kept for per protocol analysis. At the first cycle of treatment a decline in LH peak amplitude was observed in all women (16/16) of the L5 group and in 12 women out of 14 in the L8 group. For all women under treatment, graphs show a decrease in progesterone secretion parallel to decline in LH secretory peak amplitude as well as significant decline in estradiol secretion. Clinical tolerance was good.
DISCUSSION AND CONCLUSION: Chlormadinone acetate induces anti-gonadotropic activity which is similar to other nor-progesterone and nor-testosterone derived progestins. This activity is shown at first cycle when the drug is used from day 5; when the drug is used from day 8, cycle 2 or 3 must be waited for in order to obtain the same result.
OBJECTIVE: Determine chlormadinone acetate's antigonadotropic activity when administered according to two schemes: from the day 5 to day 25 (L5) and from day 8 to day 25 (L8) of the menstrual cycle.
PATIENTS AND METHODS: Randomized monocentric study carried out in twenty normally cycling healthy women included in two parallel groups and receiving 10 mg of chlormadinone acetate once a day, either from day 5 to day 25, or from day 8 to day 25 of the menstrual cycle. Hormonal dosages were determined with blood samplings performed each day from day 5 to day 25 of each menstrual cycle for estradiol, FSH and LH and from day 14 to day 25 of each cycle for progesterone.
RESULTS: Sixteen women in group L5 and 14 in group L8 were kept for per protocol analysis. At the first cycle of treatment a decline in LH peak amplitude was observed in all women (16/16) of the L5 group and in 12 women out of 14 in the L8 group. For all women under treatment, graphs show a decrease in progesterone secretion parallel to decline in LH secretory peak amplitude as well as significant decline in estradiol secretion. Clinical tolerance was good.
DISCUSSION AND CONCLUSION: Chlormadinone acetate induces anti-gonadotropic activity which is similar to other nor-progesterone and nor-testosterone derived progestins. This activity is shown at first cycle when the drug is used from day 5; when the drug is used from day 8, cycle 2 or 3 must be waited for in order to obtain the same result.