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Biomedical subjects

V Odlind

Publications and source records attributed to V Odlind.

At least 73 records · Page 4Linked to original sources

Contraception with NORPLANT implants and NORPLANT-2 implants (two covered rods). Results from a comparative clinical study in Sweden.

Two-hundred-and-forty healthy women, ages 18 to 40 years, were randomized in a ratio of 2:5 to use NORPLANT implants or NORPLANT-2 implants. Through three years of use, no pregnancies were recorded among women using NORPLANT implants and two pregnancies were noted among women using NORPLANT-2 implants resulting in a cumulative net pregnancy rate of 1.3 +/- 0.9 per 100 acceptors (mean +/- SE) by the end of year three. This difference was not statistically significant. During the fourth year, no pregnancies were observed in the NORPLANT group, but 4 pregnancies occurred in the NORPLANT-2 group. The most common reason for terminating the study was bleeding disturbances. During the first year there were significantly more terminations due to bleeding problems in the NORPLANT group than in the NORPLANT-2 group. However, during the second year of use the proportion of women discontinuing for bleeding problems dropped considerably among NORPLANT users and during the third year very few women in either group discontinued because of bleeding problems. The continuation rates after one year were for NORPLANT users 59.4% and for NORPLANT-2 users 77.2%. Corresponding figures after three years of use were 46.1% and 51.7%, respectively. The second most common reason for discontinuation was depression and other mood changes. In both groups we noted a slight increase in weight during the study and a slight decrease in blood pressure and hemoglobin levels with time. In conclusion, both NORPLANT and NORPLANT-2 implants are very effective methods for contraception. The efficacy of NORPLANT-2 implants, however, was not acceptable during the fourth year of use in this study. The latter system could, however, become a suitable three-year contraceptive method, possibly with less bleeding disturbances than NORPLANT in the first year.

Adolescent↗

Chlamydia trachomatis among sexually active teenage girls. Lack of correlation between chlamydial infection, history of the patient and clinical signs of infection.

Cultures for Chlamydia trachomatis were obtained from 1012 teenage girls attending an adolescence clinic mainly for family planning; C. trachomatis was isolated from 174 (17.2%). The proportion of chlamydia-positive girls varied between 15.7% and 28.5% depending whether or not there were symptoms and signs of infection. Neither the history nor the finding at pelvic examination offered conclusive evidence for or against the presence of an infection with C. trachomatis. Of the chlamydia-positive, untreated, asymptomatic girls, 17.5% developed symptoms of a genital infection within 3 months. There was a statistically significant difference in the proportion of positive cultures by the two investigators, suggesting that the procedure for specimen collection is of great importance.

Adolescent↗

Plasma levels of levonorgestrel and free levonorgestrel index in women using NORPLANT implants or two covered rods (NORPLANT-2).

Plasma levels of levonorgestrel, sex hormone binding globulin (SHBG) and estradiol were studied during four years in 283 healthy women using either NORPLANT implants or two covered rods (NORPLANT-2). The women were randomized to use either type of implant. Both implant systems have previously been shown to have similar release rates of levonorgestrel. In both groups plasma levels of levonorgestrel decreased throughout the study, and there were no statistically significant differences between the two groups in mean plasma levels of levonorgestrel. During the study 8 women became pregnant. All pregnancies but one occurred after 35 months of implant use and only in women using the covered rods. No significant differences were seen between the women who became pregnant and the rest of the group using two covered rods with respect to plasma levels of levonorgestrel. SHBG capacity tended to be somewhat higher in women using the two covered rods. As levonorgestrel is to a great extent bound to SHBG, and in that form not biologically active, a "free levonorgestrel index" was calculated as a ratio between levonorgestrel and SHBG. This index was significantly lower in users of two covered rods than in users of NORPLANT implants at 1, 12 and 48 months of use. Women who became pregnant had significantly lower "free levonorgestrel index" than had the rest of the group. It is postulated that the difference in "free levonorgestrel index" between users of the two implant systems reflect differences in release rate, the covered rods having a lower release rate of levonorgestrel than NORPLANT throughout the observation period. It is concluded that "free levonorgestrel index" is a better parameter than levonorgestrel plasma levels to describe implant function, and to discriminate women who are at risk of pregnancy.

Adult↗

Plasma levels of cortisol and corticosteroid binding globulin during use of Norplant-2 implants.

Plasma levels of cortisol and corticosteroid binding globulin (CBG) were studied during one year in eleven healthy women using NORPLANT-2 implants. NORPLANT-2 implants release approximately 50 ug of levonorgestrel/day. A significant diurnal variation of cortisol levels was found during the study. No significant change in cortisol levels compared to pretreatment levels was found. Levels of CBG showed no diurnal variation, but decreased significantly during use of the implants. This was most probably due to a direct effect of the levonorgestrel, as the levels of estradiol did not change compared to pretreatment levels, except for the values after 6 months that were significantly lower than pretreatment levels. A "free cortisol index" calculated as: level of cortisol/level of CBG, was unchanged during treatment compared to pretreatment levels. It is concluded that although CBG levels were reduced, no significant change in cortisol patterns was seen during use of the implants.

Adult↗

Termination of early human pregnancy with epostane.

Fifty-six healthy women, with a gestational length of less than 49 days from the last menstrual period, who requested termination of pregnancy were treated with Epostane, a progesterone synthesis inhibitor. Epostane, which competitively inhibits the 3 beta-hydroxy steroid dehydrogenase enzyme system, was given in the dose 200 mg X 4 for seven days. Physical examination, routine laboratory screening and determination of hCG, progesterone, estradiol and cortisol was performed on days 0, 7 and 14. The treatment resulted in 84% complete abortions (90% among women completing therapy). Two women experienced vaginal bleeding only, while 7 were non-responders. Among subjective side effects nausea dominated totally and was also the reason for discontinuation in 4 cases. The average length of bleeding among women with complete abortions was 10.7 days and the decrease in hemoglobin and hematocrit was very slight. Routine laboratory values remained within the normal range. Cortisol levels were elevated on day 7 compared to days 0 and 14, but all single values were within the normal limits.

Abdomen↗

Early pregnancy termination with antiprogestins: a comparative clinical study of RU 486 given in two dose regimens and Epostane.

Mifepristone, (RU 486, Roussel Uclaf, Romainville, France), a progesterone (P) receptor blocking agent, and Epostane, (WIN 32,729, Sterling-Winthrop, Guildford, United Kingdom), a P synthesis inhibitor, were compared for their ability to terminate early human pregnancy. Seventy-eight healthy women, with a gestational length of less than 49 days from the last menstrual period and who requested termination of pregnancy, were recruited to the study. The patients were randomly allocated to three treatment regimens: (1) Mifepristone 25 mg bid for 7 days; (2) Mifepristone 50 mg bid for 7 days; and (3) Epostane 200 mg qid for 7 days. The results of the study confirmed that both compounds are potent abortifacients in early human pregnancy. No difference in efficacy was seen between the two dose regimens of Mifepristone, which both resulted in 61% complete abortions. Seventy-three percent aborted completely in the Epostane group. Subjective side effects, especially nausea, were more common in the women treated with Epostane, but no serious side effects were seen.

Abortion, Induced↗

Oral contraceptive absorption and sex hormone binding globulins in obese women: effects of jejunoileal bypass.

Plasma levels of two oral contraceptive gestagens were studied during 24 hour oral challenges in seven morbidly obese women after jejunoileal bypass comparing the results to unoperated normal controls. To study binding and transport of the gestagens, sex hormone binding globulin levels were determined in these patients, in normal-weight controls, and in unoperated morbidly obese patients. The unoperated morbidly obese patients had significantly decreased levels of sex hormone binding globulin, compared to normal-weight controls and to the jejunoileal bypass patients, whose levels were similar to the controls. The jejunoileal bypass patients had a reduced capacity to absorb oral contraceptive gestagens, although the plasma levels were of the same magnitude found in normal subjects using lower doses of gestagens. However, the gestagen to sex hormone binding globulin ratio was lower in jejunoileal bypass patients, implying reduced biologic activity and thus reduced contraceptive efficiency of the gestagen. There were no enzymatic or morphologic signs of liver dysfunction. No correlations were found between plasma gestagen levels and number or volume of stools, fecal fat excretion, or intravenous C-cholic acid load. It is concluded that caution must be exercised in prescribing oral contraceptives to jejunoileal bypass patients.

Administration, Oral↗

Enhanced metabolism of levonorgestrel during phenytoin treatment in a woman with Norplant implants.

A 26-year-old woman, treated with phenytoin for 10 years because of epilepsy, had Norplant subdermal implants inserted after a legal abortion. She became pregnant again after nine months of Norplant use. Her plasma levonorgestrel (LNG) levels were followed during one month during phenytoin treatment and then later during one month after discontinuation of phenytoin. During phenytoin treatment, plasma LNG levels were markedly below the levels found in healthy women with Norplant. There was a pronounced, statistically significant increase in plasma LNG levels after discontinuation of phenytoin. The plasma levels of sex hormone binding globulin were markedly above those found in normal healthy women during treatment with phenytoin and decreased significantly after cessation of phenytoin. The effects on the pharmacokinetics of LNG were reflected by effects on the menstrual cycle. During phenytoin treatment, the woman had regular ovulatory menstrual cycles. After cessation of phenytoin, her cycles became irregular and during the study period of one month, no signs of ovulation were found. It is concluded that treatment with phenytoin during use of Norplant subdermal implants enhances the metabolism of LNG to an extent where the contraceptive efficacy is endangered.

Adult↗

Androgen levels in women using Norplant implants.

Plasma concentrations of sex hormone binding globulin (SHBG), testosterone, free testosterone, androstenedione (A4) and levonorgestrel were studied in 17 women before and during use of two levonorgestrel covered rods resulting in identical plasma concentrations of levonorgestrel as Norplant implants. There was a highly significant decrease in SHBG during treatment. Total testosterone and A4 also decreased significantly. Free testosterone remained unchanged. Diurnal variations were found to occur for A4, total and free testosterone, but not for SHBG or levonorgestrel. Moreover, plasma concentrations of testosterone, free testosterone, levonorgestrel and SHBG were measured in a second group of 88 women participating in a clinical study on Norplant implants, who at the one year follow-up visit either denied or claimed to have developed increased facial acne during treatment. There was no difference regarding SHBG, total testosterone, free testosterone or levonorgestrel between the groups of women with and without facial acne. However, the women in the group noticing increased acne during treatment, reported significantly more often to have had acne before treatment compared to the women who did not notice increased acne during treatment. It is concluded that treatment with Norplant implants does not result in increasing plasma levels of androgens.

Acne Vulgaris↗

Levonorgestrel concentrations in maternal and infant serum during use of subdermal levonorgestrel contraceptive implants, Norplant, by nursing mothers.

The transfer of levonorgestrel to infants was studied in 42 lactating women in whom the contraceptive subdermal implants, Norplant, were inserted 30 to 40 days postpartum. The women breastfed their infants for one year. Simultaneous mother and infant blood samples were taken once during the year. The levonorgestrel serum concentrations were measured by radioimmunoassay. During the first postinsertion month, the levonorgestrel concentration in the infants serum amounted, on the average, to 5% of the maternal concentration. Thereafter, the ratio ranged from 8 to 13%. The implications of this finding are discussed.

Breast Feeding↗

Effects of Epostane on progesterone synthesis in early human pregnancy.

Healthy women requiring abortion in early normal pregnancy were recruited to study the abortifacient effects of different doses of Epostane, an inhibitor of 3 beta-hydroxy steroid dehydrogenase, that previously has been shown to interfere with progesterone production in the luteal phase of humans and to have abortifacient effects in animals. A single dose of 100 mg resulted in decreasing progesterone and estradiol, which rapidly recovered, and none of the women started to bleed. Repeated doses of 50 or 100 mg during one day resulted in a more pronounced decrease in both progesterone and estradiol, but no bleeding. When treatment was prolonged over several days with 100 mg X 4 for five days and 400 mg X 2 for four days, respectively, a suppression of progesterone and estradiol was found and two out of four and eight out of ten women started to bleed and subsequently aborted. The treatment was well tolerated by most of the women. Routine laboratory parameters remained unaltered throughout treatment. Cortisol levels remained within the normal range.

Abortifacient Agents↗

Aspects of thyroid function during use of Norplant implants.

Plasma thyroxin (T4), triiodothyronine (T3), T3-uptake and thyroid stimulating hormone (TSH) were measured in 18 women using Norplant implants or Norplant-2 implants for six months. Free T4-index and free T3-index were also calculated. All women had used non-hormonal contraceptives before insertion of the implants. T4 decreased and T3-uptake increased, indicating a lower level of thyroid binding proteins during treatment. Free T4-index remained unchanged, indicating that the free concentration of thyroxin was unaltered. All women were euthyroid and TSH was unchanged. It is concluded that treatment with Norplant implants does not result in a change in thyroid function.

Adult↗