|Budget Amount *help
¥3,800,000 (Direct Cost : ¥3,800,000)
Fiscal Year 1999 : ¥500,000 (Direct Cost : ¥500,000)
Fiscal Year 1998 : ¥3,300,000 (Direct Cost : ¥3,300,000)
HRT(hormone replacement therapy) has prevailed worldwide among climacteric and elderly women. However, progestogen, when administered systemically in combination with estrogen, sometimes make patients' mood depressive. In this study, we prepared progesterone vaginal suppositories and examined their efficacy.
A : Making vaginal suppositories. H-15 : progesterone(ampule) 50mg+Witepsol H15 : 1.2g. E-85 : same 50mg+Witepsol E-85 : 1.32g. RE : progesterone(reagent) 50mg+H15 : 1.2g.
B : Single administration : To 13 patients receiving hysterectomy, a PVS was administered before operation (H-15 : 2, E-85 : 7, TE : 4). Serum progesterone was measured before, and after administration, and myometrial and endometrial progesterone concentrations were also measured. Serum progesterone level was highest at 2 or 4 hours after administration, and lowered ed to basal level at 24 hours. In these patients, myometrial and endometrial progesterone level were 12.0【plus-minus】15.5ng/g(range : 2-54), and 26.6【p
lus-minus】25.5(range : 2.5-230) which were 0.67-5.93 and 0.53-17.5(average : 5.9) folds of the maximal serum level, respectively.
C : Administration in HRT : PVSs were administered to 17 patients in HRT. To 16 patients PVSs were administered cyclically (basically 10 days in a cycle, 68cycles), H-15 was used only in 4 cycles (4 patients) because all of the patients claimed inconvenience (too soft). E-85 (25 cycles, 12 patients) was hard enough. RE (45 cycles, 10 patients) was easiest to use. Withdrawal bleeding (WDB) was analyzed in 68 cycles of cyclic administration. Bleeding did not occur in three cycles of RE. In 25 cycles WDB started before finishing the ten suppositories. In the rest 40 cycles, WDB started 1 to 8 days after cessation of PVS. Duration of bleeding was 4【plus-minus】1 days, amount of bleeding was moderate in most cycles. In some cycles, progesterone effect was confirmed with ultra sonogram and/or histological examination of the endometrium. Vaginal discharge and genital discomfort were complained in most of H-15 cycles and some E-85 cycles. Depressive mood was infrequent. Less