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  • Title: The effect of RU486 administered during the proliferative and secretory phase of the cycle on the bleeding pattern, hormonal parameters and the endometrium.
    Author: Swahn ML, Johannisson E, Daniore V, de la Torre B, Bygdeman M.
    Journal: Hum Reprod; 1988 Oct; 3(7):915-21. PubMed ID: 2846630.
    Abstract:
    Seventeen healthy women aged 24-45 years with regular menstrual periods, proven fertility and not using steroidal contraceptives or IUD were recruited for the study. The volunteers were followed during one control, one treatment and one follow-up cycle. Daily morning urine samples were obtained during the control and the treatment cycle. The samples were analysed with regard to pregnanediol glucuronide (P2-G), oestrone glucuronide (E1-G), oestradiol (E2), progesterone (P4), LH and creatinine. During the entire 3-month study the subjects kept a record of uterine bleeding and side effects. The subjects received 50 mg RU486 daily either on cycle days 7-10 (n = 7) or on cycle days 20-23 (n = 10). An endometrial biopsy was taken on cycle day 10 in the first group and on cycle days 21-28 in the second group of patients. Treatment during the proliferative phase caused significant prolongation of the cycle length due to a delay of the oestrogen and LH surge. However, once the oestrogen concentration started to increase, the remaining part of the cycle was normal. The length of the follow-up cycle was similar to that of the control cycle. The morphology of the endometrium did not differ from control samples taken from untreated women at the same time of the cycle. All ovulating women (n = 9) treated in the mid-luteal phase started to bleed on the 3rd to 4th day of the treatment.(ABSTRACT TRUNCATED AT 250 WORDS) 17 healthy women ages 24-45 years with regular menstrual periods, proven fertility, and no use of steroid contraceptives or IUD were recruited for this study. Volunteers were followed during 1 control, 1 treatment, and 1 follow-up cycle. Daily morning urine samples were obtained during the control and treatment cycles. The samples were analyzed for pregnanediol glucuronide (P2-G), estrone glucuronide (E1-G), estradiol (E2), progesterone (P4), LH, and creatinine. Over the 3-month study, the subjects kept a record of uterine bleeding and side effects. The subjects received 50 mg RU 486 daily either on cycle days 7-10 (n=7) or on cycle days 20-23 (n=10). An endometrial biopsy was taken on cycle day 10 in the 1st group and on cycle days 21-28 in the 2nd group of patients. Treatment during the proliferative phase caused significant prolongation of the cycle due to a delay in the estrogen and LH surges. Once the estrogen concentration was on the increase, the remainder of the cycle was normal. The length of the follow-up cycle was similar to that of the control and the morphology of the endometrium did not differ from control samples taken from untreated women at the same time of cycle. All ovulating women (n=9) treated during the midluteal phase began to bleed on the 3rd-4th days of treatment; in 4 of these women, bleeding was scanty and was followed by menstrual-like bleeding at the expected time. The remaining 5 volunteers had heavier bleeding and did not have new bleeding until a month later. The secretory phase lasted 16.5 +or- 1.3 days in women with 2 bleeding episodes and 11.8 +or- 1.9 days in women with 1 bleeding episode (p 0.05). The hormonal parameters were similar in both groups until the start of treatment. In those with 1 bleeding episode, treatment was associated with a reduction in progesterone concentration, while for those with 2, progesterone concentration remained elevated until the 2nd episode. Light microscopic examination of the endometrium revealed unique changes in the endometrial morphology. Results indicate that Ru 486 acts mainly on the endometrium but a direct or indirect effect on the corpus luteum cannot be discounted. The age of the corpus luteum may be of importance for its susceptibility to RU 486 treatment.
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