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PubMed1991

Single and multiple administration of a new triphasic oral contraceptive to women: pharmacokinetics of ethinyl estradiol and free and total testosterone levels in serum.

Ethinyl estradiol is part of almost every combined oral contraceptive, and its pharmacokinetic characteristics have been thoroughly investigated in numerous studies. However, little is known about its pharmacokinetics during long-term administration, as compared with single-dose administration. In this study 10 women received a triphasic formulation that contained ethinyl estradiol together with the progestin gestodene over one treatment cycle. Mean area under the curve values of ethinyl estradiol were significantly higher on the last treatment day, as compared with the corresponding values obtained from the same women after single-dose administration. However, the observed increase in area under the curve was within the range of pharmacokinetic accumulation, to be expected on the basis of dosing interval and terminal half-life. Another point of interest was the effect of the triphasic preparation on testosterone concentrations in serum. Both total and free testosterone levels were suppressed by about 60% as compared with pretreatment values, and there was no correlation with corresponding sex hormone-binding globulin levels in the serum.

Adult↗
PubMed1987

Metabolic effects of two low-dose triphasic oral contraceptives containing ethinyl estradiol and levonorgestrel or gestodene.

A well-known triphasic oral contraceptive (OC) containing ethinyl estradiol (EE) plus levonorgestrel (LNG) was compared with a triphasic containing the same dose of EE in combination with a 14% smaller dose of a new progestogen gestodene (GTD), in a prospective study of 24 and 20 healthy young women, respectively. Serial determinations of lipids, lipoproteins, and carrier proteins, and repeated standardized oral glucose tolerance tests (OGTTs) were conducted during 12 months of OC use. All lipid concentrations recorded before and during both treatments were strictly within the normal range. After 12 months, no significant fluctuations were observed in levels of total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, and apolipoprotein A1; concentrations of total triglycerides, phospholipids, and apolipoprotein B were slightly but significantly increased; the epidemiologically important ratios of HDL-cholesterol:total cholesterol and apolipoprotein A1:apolipoprotein B were not significantly changed, while the ratio of LDL-cholesterol:HDL-cholesterol was significantly decreased at 12 months of use of the GTD triphasic. SHBG levels (+ 100% over basal during use of the LNG-OC and + 200% with the GTD-OC) and transcortin (+ 100% over basal) increased early and remained stable. During use of the LNG-OC, glucose tolerance was strictly unchanged, while insulin response to a 75-g glucose load was transiently increased at 6 months (area under the curve [AUC] + 29%) before returning to normal at 12 months. During GTD-OC treatment, glucose tolerance was slightly impaired (AUC + 14%) at 6 months but back to normal at 12 months, while insulin response during OGTT was completely unaltered.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1988

Women's attitudes to withdrawal bleeding and their knowledge and beliefs about the oral contraceptive pill.

One hundred and fifty-eight attenders at general practices and family-planning clinics, and 20 young female doctors volunteered to complete a questionnaire about how women take the oral contraceptive pill, their knowledge of the Pill and their attitudes to withdrawal bleeding. Forty-three per cent of female patients has used the Pill to alter the time of withdrawal bleeding. Twenty-two per cent of female patients had taken the Pill daily for more than six weeks on at least one occasion and all reported positive experiences. However, 83% of female patients believed that it was necessary to bleed monthly when taking the Pill and 69% of the female patients believed that continuous use of active medication is undesirable. The over-all knowledge of the Pill was poor and 43% of female patients did not know what to do if they missed two consecutive Pills. Female doctors were better informed but had similar attitudes about the Pill to those of other women. Forty-six per cent of the female patients and 55% of young female doctors would chose to bleed at intervals of three months or greater if they could determine their own Pill regimen.

Adult↗
PubMed1991

Evaluation and therapy of breakthrough bleeding in women using a triphasic oral contraceptive.

This study was designed to investigate the incidence and pattern of breakthrough bleeding (BTB) in 1,259 women who were prescribed for the first time a triphasic oral contraceptive (OC, 7-7-7) and to evaluate a hypothesis of management for BTB persisting after three cycles. The new users were compared with a control group of 696 women who had used various OCs for at least 6 months. The incidence of BTB in the control group was 16.8% and in the new users was 24.9%, 17.5%, and 15.3% in the first 3 months, respectively. Breakthrough bleeding occurred late in the 7-7-7 package in 58% and early or midway through the package in 17% and 25%, respectively. We hypothesized that late-package BTB would improve if the patient was switched to a monophasic pill similar to the relatively estrogenic formulation of the beginning of the package and vice versa for early or midpackage BTB. Seventy women with BTB at 3 months were randomly given 0.5/35 or 1/35 for a further 3 months. Breakthrough bleeding was more likely (P less than 0.05) to improve in women switched to 1/35 compared with 0.5/35 regardless of where in the package BTB occurred.

Adolescent↗
PubMed1992

Pharmacokinetics of ethinylestradiol and levonorgestrel after administration of two oral contraceptive preparations.

Serum concentration profiles and pharmacokinetic parameters (cmax, tmax, AUC24, AUC0-00, MRT) of ethinylestradiol (EE2) and levonorgestrel (LNG) were obtained following administration of two combined oral contraceptives. The constituents of the preparations were as follows: Gravistat (0.05 mg EE2, 0.125 mg LNG); Minisiston (0.03 mg EE2, 0.125 mg LNG). In 20 of the volunteers blood samples were taken before and up to 36 hours following the intake of a single table. In 11 women the investigation was carried out at day 21 of a treatment cycle (steady-state condition). In spite of pronounced interindividual variations of the pharmacokinetic data, a clear dependency of EE2 concentration curves on the estrogen dose of the respective preparation could be demonstrated. Under the condition of steady-state (21st day of administration) there was a slight but significant rise of the EE2 peak serum concentrations and a pronounced increase of the LNG levels, closely reflected by elevation of the AUC values. SHBG serum concentration was significantly increased by the 10th day of treatment in all subjects receiving Gravistat, whereas the mean value in the Minisiston-group did not remarkably change. Although LNG is known to be bound to SHBG with high affinity, the missing parallelism between LNG- and SHBG-concentrations suggests other (additional?) mechanisms for the elevated LNG-binding capacity in women taking combined EE2-LNG preparations.

Administration, Oral↗
PubMed1988

Lack of impairment of fluocortolone disposition in oral contraceptive users.

Seven healthy women chronically (greater than 6 months) treated with oral contraceptives and 7 age- and weight-matched female controls were studied. Each subject was given 20 mg fluocortolone orally and the plasma concentrations of total and unbound fluocortolone in multiple samples obtained during the following 24 h were determined by HPLC and equilibrium dialysis. In the subjects on oral contraceptives there was no significant change in total clearance, unbound clearance or volume of distribution at steady-state of total and unbound fluocortolone, but there was a significant increase in hydrocortisone concentration compared to the control subjects. It appears that the elimination of the synthetic corticoid fluocortolone was not impaired by chronic administration of contraceptive steroids.

Adult↗
PubMed1990

Low-dose oral contraceptives lower plasma levels of apolipoprotein E.

Three different oral contraceptive preparations were studied before and after a 3 month treatment period with respect to their effects on plasma lipoprotein parameters. A total of 58 healthy women requesting oral contraception were randomly assigned to three groups. Each woman received either monophasic preparations containing ethinylestradiol and desogestrel (M-DG); ethinylestradiol and gestodene (M-GD); or a triphasic preparation of ethinylestradiol and levonorgestrel (T-LN). As has been reported in other studies, the concentrations of total plasma cholesterol and apolipoproteins B and A-IV did not change significantly in any group. HDL cholesterol, triglycerides, apolipoproteins A-I and A-II increased or tended to increase. Despite the effects of the three hormone preparations on these lipoprotein parameters, however, each led to a highly significant decrease in apolipoprotein E plasma levels. Considering the recently reported observations that oral contraceptives increase the hepatic uptake of cholesterol-rich remnants, this decrease in apo-E plasma levels may in women that take oral contraceptives be directly correlated with increased hepatic lipoprotein metabolism.

Adolescent↗
PubMed1988

Prospective studies of insulin sensitivity in normal women receiving oral contraceptive agents.

Seven normal premenopausal women were studied before (control) and after 3 and 6 months of oral contraceptive agent (OCA) administration (30 micrograms ethinyl estradiol plus 150 micrograms levonorgestrel). The plasma glucose responses during 75-g oral glucose tolerance tests were not altered by the OCA, but the 3- and 6-month plasma insulin responses significantly exceeded control values (P less than 0.05). On a separate morning a constant iv infusion of [3H]3-glucose was given throughout a 2-h basal period and during two successive 2-h euglycemic clamp procedures at iv insulin delivery rates of 10 and 40 mU/m2.min, respectively. Endogenous glucose production rates (milligrams per kg/min) were not altered after 3 or 6 months of OCA administration. Peripheral glucose utilization rates were expressed as M (milligrams per kg/min) or the ratio of M over the prevailing plasma insulin concentration (M/I). One or both parameters were significantly reduced below control values at both insulin infusion rates after 3 months (P less than 0.05), but returned toward control values after 6 months. Serum androgen concentrations were reduced or not altered by OCA administration. We conclude that insulin resistance induced by OCA administration is manifested by reduced peripheral tissue insulin sensitivity and may ameliorate with time. This effect does not relate consistently to total plasma insulin responses during oral glucose tolerance tests or to elevated serum androgen concentrations.

Adult↗
PubMed1988

Metabolic changes in women using a long-acting monthly oral contraceptive and return of ovulation on discontinuation.

Metabolic changes were investigated in two groups of women using oral contraceptives for 5 to 16 years. Blood samples were taken during the last cycle of oral contraceptive use and three months post-treatment. One group had used a monthly oral contraceptive (MOC, 3mg quinestrol and 10mg 16-methylene chlormadinone acetate) and the second group a daily oral contraceptive (DOC, 35 micrograms ethynylestradiol and 0.625 mg norethisterone). During treatment there were increases in serum total cholesterol and triglycerides but not HDL-C, in plasma total cortisol but not in renin activity, angiotensin II or urinary free cortisol excretion, in hemoglobin and some coagulation factors but not Factor X or antithrombin III, platelet function or fibrinolysis. The area under the blood glucose concentration-time curve, but not that for serum insulin, was slightly increased and there was no change in fasting blood sugar concentrations. All metabolic parameters, except plasma cortisol, which had shown an increase on treatment, had decreased to control levels within 3 months. Ovulation returned promptly in all women, the mean time being 70 days for Group MOC and 44 days for Group DOC. Thus, in spite of the long duration of use of the oral contraceptives, metabolic changes were minor.

Adult↗
PubMed1990

Exogenous sex hormones and the risk of rheumatoid arthritis.

The use of exogenous sex hormones in relation to the risk of rheumatoid arthritis (RA) was examined in a cohort of married nurses 30-55 years of age followed since 1976 in the Nurses' Health Study. Baseline information on the use of oral contraceptives, replacement estrogens, and other potential risk factors was obtained in 1976 and updated every 2 years. During 8 years of followup, 217 incident cases of polyarthritis were ascertained (115 RA and 102 undifferentiated polyarthritis). When compared with women who had never used oral contraceptives, the age-adjusted relative risk was 1.0 (95% confidence interval [CI] 0.7-1.3) for past users; however, too few women were currently using oral contraceptives for a reliable estimate of its effect. Among postmenopausal women, 123 cases of RA were reported. Compared with postmenopausal women who never used replacement estrogens, current users had an age-adjusted relative risk of 1.3 (95% CI 0.9-2.0), past users had an age-adjusted relative risk of 0.7 (95% CI 0.5-1.2), and ever users had a relative risk of 1.0 (95% CI 0.7-1.4). These data do not show a protective effect of past use of oral contraceptives or replacement estrogens for RA; however, a modest protective effect of current oral contraceptive use cannot be excluded.

Adult↗
PubMed1989

Effect of oral contraceptives or dexamethasone on plasma beta-endorphin during the menstrual cycle.

Several studies have showed a significant increase of plasma beta-endorphin levels during the periovulatory days of the menstrual cycle. The aim of the present study was to investigate the origin of the periovulatory changes of plasma beta-endorphin, trying to discriminate between a possible ovarian and/or pituitary origin. Daily plasma beta-endorphin, luteinizing hormone (LH), and cortisol levels were measured from the 8th to the 20th day of the menstrual cycle in healthy normal-cycling women (10 cases) before and during dexamethasone (DEX; 6 cases) or estroprogestinic treatment with monophasic (5 cases) or triphasic (5 cases) pill. In the control menstrual cycle, during the preovulatory days, a significant increase of plasma beta-endorphin was found. While oral contraceptives abolished the midcycle increase of plasma beta-endorphin, the periovulatory plasma beta-endorphin peak was present during DEX treatment. Plasma cortisol levels did not show any significant change throughout the control menstrual cycle, while they were significantly lowered by the DEX administration and significantly increased during estroprogestinic treatment. These results suggest that the increase of plasma beta-endorphin during the periovulatory days is related to the ovulatory function, and suggest a possible ovarian origin.

Adolescent↗
PubMed1988

Treatment with dexamethasone of androgen excess in adolescent patients.

Fourteen hirsute girls, ages 12 to 22 years (mean +/- SD: 17.2 +/- 2.6 years), in whom 21-hydroxylase deficiency was excluded by a 1-hour intravenous alpha 1-24 corticotropin test, were evaluated by a 4-day dexamethasone test and then treated with a bedtime dose of dexamethasone (0.5 mg in 10 patients, 0.25 mg in four) for 0.6 to 3.4 years (1.3 +/- 0.8 years). Hirsutism decreased in four patients, did not change in nine, and increased in one. Of the 10 patients with irregular menses, only three developed regular cycles while taking dexamethasone. During long-term dexamethasone therapy, serum levels of testosterone decreased from 102 +/- 22 to 72 +/- 27 ng/dL, free testosterone from 35 +/- 11 to 19 +/- 8 pg/mL, and dehydroepiandrosterone sulfate from 396 +/- 138 to 171 +/- 101 micrograms/dL. Although free testosterone decreased to less than 15 pg/mL in eight of 14 patients with the suppression test, only four patients had free testosterone levels less than 15 pg/mL during therapy. Two of the 14 patients have had no recurrence of hirsutism or increase in serum androgens after 28 and 29 months, respectively, after dexamethasone therapy was discontinued. Oral contraceptives were given to nine patients inadequately responsive to bedtime dexamethasone therapy. The mean percent decrease of testosterone and free testosterone levels during oral contraceptive therapy was significantly greater than during long-term treatment with dexamethasone, and hirsutism lessened in all. We conclude that a single bedtime dose of dexamethasone is satisfactory only in patients who maintain serum free testosterone values less than 15 pg/mL without side effects. For other patients, either another glucocorticoid or, in most cases, ovulation suppression should be prescribed for adolescents with progressive hirsutism and elevated androgen levels.

17-Ketosteroids↗
PubMedDate not supplied

Possible interaction between oxcarbazepine and an oral contraceptive.

The effect of oxcarbazepine (OCBZ) on the kinetics of an oral contraceptive containing ethinyloestradiol (EE) and levonorgestrel (LNG) was investigated in 13 healthy female volunteers who had previously received the contraceptive for at least 3 months. After 15 days of the first study cycle, each subject received, in addition to the oral contraceptive, 300 mg OCBZ on day 16, 300 mg twice daily on day 17, and 300 mg three times daily from day 18 of the first cycle to day 18 of the next menstrual cycle. The area under the curve values for both EE and LNG decreased when OCBZ was given with the oral contraceptive (p = 0.006, analysis of variance). The results indicate that OCBZ, like most antiepileptic drugs (AEDs), decreases the bioavailability of EE and LNG, perhaps by affecting metabolism or protein binding.

Adult↗