Pharmacokinetics of ethynyloestradiol in women for different populations.

The pharmacokinetics of a dose of 50 microgram ethynyloestradiol administered orally was studied in fourteen centres. Absorption was rapid and the highest serum concentrations of total ethynyloestradiol were found in most subjects at 1 h and by 24 h concentrations were less than 250 pg/ml. Calculation of the half-lives for absorption, distribution and elimination showed wide variations between subjects, the half-life of elimination varying from 2.5 h to more than 30 h. Bioavailability as measured by the area under the serum ethynyloestradiol concentration-time curve also showed more than a ten-fold variation. Intra-centre differences in the various parameters measured were as large as the inter-centre differences.

[Clinical evaluation of the progesterone T intrauterine device]. / Evaluación clínica del dispositivo intrauterino "T de progesterona".

PIP: This study describes a clinical evaluation of the Progesterone T IUD which releases a daily dose of 65 mcg of progesterone. The device is made of a copolymer of ethylene vinyl and has a transversal arm measuring 3.18 cm and a longitudinal arm 3.61 cm. The longitudinal arm contains 38 mg of natural progesterone, Barium sulfate, and silicone acetate. 146 new users of the Progesterone T were compared with 149 using the Copper 7 Gravigarde. Patients in both groups ranged in age from 17-40 years with an average of 27.2 for Progesterone T and 27.1 for Copper 7 users. Parity ranged from 1-11 with an average of 2.8 for the Progesterone T group and from 1-10 with an average of 2.7 for the Copper 7 group. The average number of spontaneous abortions was .7 for the Progesterone T group and .5 for the Copper 7 group. The groups were also comparable in previous contraceptive usage. In another study, 51 Lippes Loop D users, 52 Progesterone T users, and 50 Copper 7 users were evaluated for menstrual and intermenstrual blood loss in the 3 months prior to and the 1st, 2nd, 4th, 6th, 9th, and 12th months after insertion. At the end of 12 months, the Progesterone T and Copper 7 users respectively had pregnancy rates of 1.4 and 1.5, expulsion rates of 4.2 and 5.8, rates of removal for medical reasons of 2.8 and 3.0, and continuation rates of 87.2 and 84.6. After 1569 women-months of Progesterone T use and 1558 of Copper 7 use there were no statistically significant differences. With the Progesterone T there was 1 removal for pain, 1 for pelvic inflammation, and 2 for menstrual alterations. 4 Copper 7s were removed for bleeding. The average duration of menstrual bleeding was 6.0 days with the Progesterone T and 6.2 with the Copper 7. The number of days of true bleeding were 4.8 on average for the Progesterone T and 5.3 for the Copper 7. Intermenstrual bleeding was twice as common for the Progesterone T. There was no statistically significant difference in incidence of pain reported by the 2 groups at the beginning and end of the study. Both groups had a decline in pain at the end of the study, with the Progesterone T having a slightly more pronounced decline. The average volume of menstrual blood loss increased by 87.8% after insertion of the Lippes Loop D and by 24.3% with the Copper 7 but declined by 44.5% for the Progesterone T.^ieng

A comparative study of the effect of the Progestasert TM and Gravigard IUDs on dysmenorrhoea.

Data obtained from questionnaires on the occurrence of dysmenorrhoea in women using IUDs inserted randomly (146 of them Progestasert and 149 Copper 7) are analyzed. In both groups a reduction in the intensity of menstrual cramps was observed over 12 months of use. Although these reductions are significant in each group, they are slightly higher in Progestasert users. However, on comparing the reduction tendencies of both groups, the difference between them is not significant. No significant differences become apparent either when comparing premenstrual and intermenstrual camps. The usefulness of simple questionnaires directed at detecting the nature of pain in currently used family planning forms for IUD users is discussed.

PIP: A study was conducted at the Family Planning Centre of the Hospital Jose Joaquin Aguirre, Chile, involving 146 patients who had a Progestasert TM IUD inserted and 149 patients who had a Copper 7 IUD, Gravigard TM, inserted to determine the occurrence of dysmenorrhea. All patients completed questionnaires concerning habitual pelvic or genital pain prior to IUD insertion as well as at 1, 3, 6, and 12 months after insertion. Results indicated a reduction in menstrual cramps over 12 months of use. The Progestasert TM group showed a slightly higher reduction of menstrual cramps than Copper 7 users; however, the reductions are not significant. There were no significant differences between premenstrual and intermenstrual cramps. With the use of a questionnaire and the subjective condition of pain, it is difficult to ascertain whether the IUD produced any change in menstrual cramps or whether the reduction of pain originated in the patients; therefore, the technique of questioning the occurrence of pain may not be reliable enough.

Rate of metabolism of norethisterone in women from different populations.

The rate of metabolism of orally administered norethisterone was compared in fourteen centres by measuring plasma levels of the steroid by radioimmunoassay at varying times after oral administration of a 1 mg dose. The inter-centre differences were of the same order as the intra-centre differences. Variations in metabolism appeared not to be due to variations in body size.

Effect of oxytocin on the contractility of the human oviduct in vivo.

PIP: The effects of oxytocin, administered by either rapid or slow iv injection, on fallopian tube contractility were studies. Single iv doses were shown to consistently induce several contractions with a mean intensity of 10 mm Hg and hypertonia of varying duration. The oxytocin-induced bursts were synchronous in both tubes while normal spontaneous contractions are asynchronous. The tubes showed a high sensitivity to even small doses of oxytocin. The minimum does (threshold dose) of oxytocin eliciting tubal response in the patients was 250 mU. The intensity and duration of oxytocin-induced contractions were dose-dependent with the maximal responses obtained with oxytocin doses of 5 IU or less. The highest sensitivity was during the proliferative stage of the ovarian cycle. Continuous iv infusions of oxytocin ranging from 20 to 40 mU/minute increased tubal activity during administration. It was determined that the sensitivity of the human fallopian tube to oxytocin was higher than that of the nongravid uterus and lower than that of the mammary gland during lactation.^ieng

Effect of contraception on lactation.

PIP: A study of the effects of IUD and hormonal contraceptives, both oral and injectable, on lactation is reported. The duration of lactation in 696 multiparous healthy women under contraceptive therapy was compared with the women's own previous duration of lactation when no contraception was used. In users of Lippes loop and injectable progestogens (in medroxyprogesterone acetate, DMPA) median duration of lactation (MDL) was significantly longer, even whem DMPA was injected immediately post partum, than in the controls. The MDL of Control Group B, which excluded those patients who had spontaneously stopped lactating within 30 days after delivery, was 5.3 months. The MDL in patients receiving DMPA 30 days after delivery was 9.3 months, and it was 6.7 months in those receiving DMPA immediately post partum. The MDL in patients with IUD was 7.7 months. When oral estrogen containing quinestrol and oral sequential steroidal contraceptives were given, MDL was significantly shorter than in control lactations. In the 2 groups of patients receiving the combination of quinestrol (Q1) and quingestronol acetate (Q2) orally, one a month, the MDL was 2.5 months respectively. The data indicate that compounds containing estrogens in the doses employed in this study should not be used as contraceptive therapy by nursing mothers.^ieng

[Human tubal contractility in vivo. Analysis of the reproducibility and iatrogenics of a method of study]. / Contractilidad tubaria humana in vivo. Análisis de la reproducibilidad y yatrogénia de una metódica de estudio

PIP: Techniques for the study of tubal motility in vivo can provide important basic information, but their safety and the potential risks to which patients are exposed must be considered. 30 patients were studied, of whom 10 left the program. They were in good health and good gynecological conditions for at least 6 months after retrieving the tubal devices. Temporary changes in the ovaric cycle were observed in 3 patients; these changes and possible endocrine alterations induced by surgery must be considered in planning studies. 1 patient became pregnant 4 months after sterilization. The method was used previously by Maia and, Coutinho, and findings are consistent with those of the earlier study. The amplitude of tubal contractions is generally within 0-10 mm Hg and occasionally 0-20. Spontaneous tubal activity is asynchronous, and may be the result of the local release of certain compounds, probably catecholamines. The findings may be limited to patients subjected to tubal ligature, but findings on other patients are similar.^ieng