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255. Clinkal trials with subdermal implants or norethindrone acetate for regulating fertility
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Abstracts 0.5 mg lynestrenol. was examined in 367 cases together with I2 pregnant women and 92 untreated subjects below 40 years and 40 above 40 years old. AT 111was measured immunologically by radial immunodilfusion technique and biologically by a clotting test system. As compared with the controls, showing an age-dependent decrease, (I) EE lowered plasma AT III (immunological) more significantly than mestranol, (2) 30-4Opg of EE significantly reduced plasma and serum AT 111 and often biological AT III as well, (3) and (4) natural and conjugated estrogens as well as 0.5 mg lynestrenol (minipill) had no effect either on the immunological or on the biological AT III activity.
252. Cyproterone acetate (CPA)+
potential male contraceptive: further studies on the interactions with endocrine parameters
MOLTZ,L., R~~MMLER. A.. SCHWARTZ;U.,POST,K. and HAMMERSTEIN, J.. WHO-CCCR on Human Reproduction Berlin, Division of Gynecological Endocrinology, Sterility and Family Planning, Department of Obstetrics and Gynecology, Berlin, Federal Republic of Germany Medium-dose cyproterone acetate (CPA) was previously shown to interfere with spermatogenesis and sperm maturation to such an extent that markedly reduced fertility may be assumed: the effects on endocrine parameters, however. could not be clearly defined due to single hormone determinations. Therefore, serial estimations of LH, FSH. testosterone (T) and 5x-dihydrotestosterone (DHT) (before and after LH-RH double stimulation), prolactin and sperm analyses were performed in IO young. healthy men rdceivinn IOma of oral CPA dailv for 12 weeks. CPA sienificaitly suppressed basal LH (by 302,). FSH (40%) T (‘iO%,) and DHT (509,). The episodic fluctuations of gonadotropin levels remained unchanged, whilst that of androgen secretion was abolished. Pituitary responsiveness to LH-RH was decreased for LH and FSH. Prolactin was significantly elevated in 8 out of IO males (by 7596). All changes were completely reversible. The inhibitory effects on LH and FSH are best explained by the predominantly progestational activity of CPA which is not fully counterbalanced by its antiandrogenic action as originally thought. The more extensive suppression of T and DHT may be not only due to the decrease in gonadotropin secretion but possibly also to direct effects of CPA at the testicular level.
bination with progestational steroids remain to be investigated.
254. Oral contraceptives and serum enzymes in women GUPTA, U.. KHUTETA, K. P. and GUPTA, S. N., Upgraded Department of Physiology. Sawai Man Singh Medical College. Jaipur. India The effect of oral contraceptives on the less studied but phosphohexose isomerace important enzymes-serum (PHI). ornithine carbamyl transferase (OCT) and creatine phosphokinase (CPK)-was studied in female subjects of conceptual age at the end of the third, sixth and ninth consecutive menstrual cycle. The PHI and OCT showed a significant rise whilst the insignificant fall of CPK was variable. This may be due to transient subclinical hepatocellular damage and increased glycolysis.
255. Clinical trials with subdermal implants or norethindrone acetate for regulating fertility
ENGINEER.A. D.. TANDON. P. and MISRA, J. S.. Department of Obstetrics & Gynaecology, K.G’s Medical College, Lucknow, U.P.. India Silastic rods containing norethindrone acetate in two dosage schedules (65 and 99 mg) were implanted subdermally in fertile women (age range 20-35 years and parities I-IO) to evaluate their antifertility efficacy, menstrual pattern. side effects and exfoliative cytology. The implants were kept in situ for a period of I year. There were 7 pregnancies in the 65 mg group, and 3 in the 99 mg group. The total number of months of exposure was 685. Breakthrough bleeding was the commonest complaint but removal on this account was necessary in only one case. No significant side-effects were noted in any case. Two cases of mild dysplasia which were encountered in exfoliative cytological study were found to have regressed back to normal. Since the maximum number of pregnancies (5 out of IO cases) were noted after the 10th month it appears that the implant was active for a IO month period and better results might have been obtained if the second implant was inserted at this period rather than at the end of twelve months.
256. Contraceptive steroids in milk and serum of lactating women
253. Trial 01 testosterone undecanoate for male fertility control
NIEXHLAG. E., HOOGEN,H.. B~~LK,M., SCHUSTER.H. and WICKINGS.E. J., Abtlg. Experimentelle EndokUniv.-Frauenklinik, Miinster. Federal rinologie, Republic of Germany Since repeated injections of testosterone (T) esters suppress sparmatogenesis. yet are impractical for male fertility control, we have investigated the use of the orally effective T undecanoate (TU) in this context. Of 8 normal volunteers (age 20-30 years) receiving 240mg TU/day for I2 weeks. one developed azoospermia and one oligospermia (under 5 mill/ml sperms). The remaining 6 subjects showed an inconsistent reduction in sperm counts, but not below 30 milljml sperms. Motility and morphology were unaffected. Plasma FSH and LH levels were reduced during treatment. Sexual activity, frequency of ejaculations and testicular size were not influenced in any subject. Since “infertility” was achieved in only 2 out of 8 men, TU alone is not suitable for male fertility control. Its merits in com-
TODDYWALLA, V. S., MEHTA, S., JOSHI, L., VIRKAR, K. D. and SAXENA, B. N., Institute for Research in Reproduction, Parel, Bombay-400012. India The choice of a suitable contraceptive during the postpartum period is still controversial. In this study 6 women taking oral norethisterone [(NET) 35Opg daily] were compared with 8 women using subcutaneous biodegradable implants (NET : 25mg. 4 women; o-norgestrel D-Ng z 22mg, 4 women). In oral contraceptive users the highest amount of NET appeared both in milk and serum at 2 h (serum 2156pg4532 pg/ml, milk 254pg555 pg/ml) and even after 24 h the drug levels were lower but still detectable (serum I 13 pg-889 pg/ml, milk < 50 pg-130 pg/ml). The maximal levels (NETserum I364 pg-1832 pg/ml, milk 134 pg-244 pg/ml: o-Ng-serum 608 pg-912 pgjml, milk 91 pg-I IO pg/ml) were obtained within 48 h after insertion of the implants. The steady-state levels in the blood were reached within I4 days with NET implant (serum 550 pg-880 pg/ml) and within 7 days (serum with D-Ng implants 550 pg-660 pgiml). However, these drugs were not detect-
Abstracts 0.5 mg lynestrenol. was examined in 367 cases together with I2 pregnant women and 92 untreated subjects below 40 years and 40 above 40 years old. AT 111was measured immunologically by radial immunodilfusion technique and biologically by a clotting test system. As compared with the controls, showing an age-dependent decrease, (I) EE lowered plasma AT III (immunological) more significantly than mestranol, (2) 30-4Opg of EE significantly reduced plasma and serum AT 111 and often biological AT III as well, (3) and (4) natural and conjugated estrogens as well as 0.5 mg lynestrenol (minipill) had no effect either on the immunological or on the biological AT III activity.
252. Cyproterone acetate (CPA)+
potential male contraceptive: further studies on the interactions with endocrine parameters
MOLTZ,L., R~~MMLER. A.. SCHWARTZ;U.,POST,K. and HAMMERSTEIN, J.. WHO-CCCR on Human Reproduction Berlin, Division of Gynecological Endocrinology, Sterility and Family Planning, Department of Obstetrics and Gynecology, Berlin, Federal Republic of Germany Medium-dose cyproterone acetate (CPA) was previously shown to interfere with spermatogenesis and sperm maturation to such an extent that markedly reduced fertility may be assumed: the effects on endocrine parameters, however. could not be clearly defined due to single hormone determinations. Therefore, serial estimations of LH, FSH. testosterone (T) and 5x-dihydrotestosterone (DHT) (before and after LH-RH double stimulation), prolactin and sperm analyses were performed in IO young. healthy men rdceivinn IOma of oral CPA dailv for 12 weeks. CPA sienificaitly suppressed basal LH (by 302,). FSH (40%) T (‘iO%,) and DHT (509,). The episodic fluctuations of gonadotropin levels remained unchanged, whilst that of androgen secretion was abolished. Pituitary responsiveness to LH-RH was decreased for LH and FSH. Prolactin was significantly elevated in 8 out of IO males (by 7596). All changes were completely reversible. The inhibitory effects on LH and FSH are best explained by the predominantly progestational activity of CPA which is not fully counterbalanced by its antiandrogenic action as originally thought. The more extensive suppression of T and DHT may be not only due to the decrease in gonadotropin secretion but possibly also to direct effects of CPA at the testicular level.
bination with progestational steroids remain to be investigated.
254. Oral contraceptives and serum enzymes in women GUPTA, U.. KHUTETA, K. P. and GUPTA, S. N., Upgraded Department of Physiology. Sawai Man Singh Medical College. Jaipur. India The effect of oral contraceptives on the less studied but phosphohexose isomerace important enzymes-serum (PHI). ornithine carbamyl transferase (OCT) and creatine phosphokinase (CPK)-was studied in female subjects of conceptual age at the end of the third, sixth and ninth consecutive menstrual cycle. The PHI and OCT showed a significant rise whilst the insignificant fall of CPK was variable. This may be due to transient subclinical hepatocellular damage and increased glycolysis.
255. Clinical trials with subdermal implants or norethindrone acetate for regulating fertility
ENGINEER.A. D.. TANDON. P. and MISRA, J. S.. Department of Obstetrics & Gynaecology, K.G’s Medical College, Lucknow, U.P.. India Silastic rods containing norethindrone acetate in two dosage schedules (65 and 99 mg) were implanted subdermally in fertile women (age range 20-35 years and parities I-IO) to evaluate their antifertility efficacy, menstrual pattern. side effects and exfoliative cytology. The implants were kept in situ for a period of I year. There were 7 pregnancies in the 65 mg group, and 3 in the 99 mg group. The total number of months of exposure was 685. Breakthrough bleeding was the commonest complaint but removal on this account was necessary in only one case. No significant side-effects were noted in any case. Two cases of mild dysplasia which were encountered in exfoliative cytological study were found to have regressed back to normal. Since the maximum number of pregnancies (5 out of IO cases) were noted after the 10th month it appears that the implant was active for a IO month period and better results might have been obtained if the second implant was inserted at this period rather than at the end of twelve months.
256. Contraceptive steroids in milk and serum of lactating women
253. Trial 01 testosterone undecanoate for male fertility control
NIEXHLAG. E., HOOGEN,H.. B~~LK,M., SCHUSTER.H. and WICKINGS.E. J., Abtlg. Experimentelle EndokUniv.-Frauenklinik, Miinster. Federal rinologie, Republic of Germany Since repeated injections of testosterone (T) esters suppress sparmatogenesis. yet are impractical for male fertility control, we have investigated the use of the orally effective T undecanoate (TU) in this context. Of 8 normal volunteers (age 20-30 years) receiving 240mg TU/day for I2 weeks. one developed azoospermia and one oligospermia (under 5 mill/ml sperms). The remaining 6 subjects showed an inconsistent reduction in sperm counts, but not below 30 milljml sperms. Motility and morphology were unaffected. Plasma FSH and LH levels were reduced during treatment. Sexual activity, frequency of ejaculations and testicular size were not influenced in any subject. Since “infertility” was achieved in only 2 out of 8 men, TU alone is not suitable for male fertility control. Its merits in com-
TODDYWALLA, V. S., MEHTA, S., JOSHI, L., VIRKAR, K. D. and SAXENA, B. N., Institute for Research in Reproduction, Parel, Bombay-400012. India The choice of a suitable contraceptive during the postpartum period is still controversial. In this study 6 women taking oral norethisterone [(NET) 35Opg daily] were compared with 8 women using subcutaneous biodegradable implants (NET : 25mg. 4 women; o-norgestrel D-Ng z 22mg, 4 women). In oral contraceptive users the highest amount of NET appeared both in milk and serum at 2 h (serum 2156pg4532 pg/ml, milk 254pg555 pg/ml) and even after 24 h the drug levels were lower but still detectable (serum I 13 pg-889 pg/ml, milk < 50 pg-130 pg/ml). The maximal levels (NETserum I364 pg-1832 pg/ml, milk 134 pg-244 pg/ml: o-Ng-serum 608 pg-912 pgjml, milk 91 pg-I IO pg/ml) were obtained within 48 h after insertion of the implants. The steady-state levels in the blood were reached within I4 days with NET implant (serum 550 pg-880 pg/ml) and within 7 days (serum with D-Ng implants 550 pg-660 pgiml). However, these drugs were not detect-