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PubMed1992

Contraception with subdermal implants releasing the progestin ST-1435: a dose-finding study.

A new modified subdermal implant releasing the potent progestin ST-1435 was studied in eleven fertile-aged women. These implants have been developed for contraception and they have a life-time of two years. Three implant lengths of 4, 6 and 8 cm were tested to find the optimal steroid dose for inhibition of ovulation. Serum samples were collected twice per week during a six-week period every six months. The concentrations of serum ST-1435, estradiol and progesterone were determined by RIA. Ovulation was inhibited by all ST-1435 doses tested. The concentration of serum progesterone was below 6 nmol/l in all samples tested showing the absence of luteinization. The concentration of serum ST-1435 increased with increasing ST-1435 dose. Serum estradiol concentrations were quite variable, showing wide range and occasional high peak values typical of progestin treatment; the mean value of serum estradiol concentrations measured did not differ with different ST-1435 doses. The results of steroid determinations led to the conclusion that a single 4 cm subdermal implant is optimal for contraception. With this dosage level, ovulation is inhibited and side effects are minimized. Bleeding control was variable. No hormonal side effects due to the progestin ST-1435 were reported. This method, using a single 4 cm subcutaneous implant releasing the progestin ST-1435 with a life-time of two years, represents a promising alternative for inhibition of ovulation and contraception.

Adult↗
PubMed1992

Increased capillary permeability for plasma proteins in oral contraceptive users.

The transcapillary fluid balance was examined in eleven women before administration of a monophasic oral contraceptive (desogestrel 0.15 mg, ethinylestradiol 0.03 mg), and after three and six months of use. The interstitial colloid osmotic pressure was measured by the "wick" method, and the interstitial hydrostatic pressure by the "wick-in-needle" method in subcutaneous tissue on thorax and leg. During the six-month observation period, the following changes were observed: Plasma colloid osmotic pressure decreased (mean 1.8 mmHg, p = 0.047), as well as serum albumin (mean 5.1 g/l, p = 0.0006), total protein concentration (mean 2.8 g/l, p = 0.0006), hemoglobin (mean 0.5 g/dl, p = 0.014) and hematocrit (mean 1.8%, p = 0.047). Blood pressure and body weight remained unchanged, but foot volume showed a significant increase. The colloid osmotic pressure gradient (plasma-interstitium) was significantly reduced. The results indicate an increase in plasma volume in addition to an increased capillary permeability to plasma proteins during oral contraceptive use. We suggest that the observed changes in transcapillary fluid balance is caused by the estrogen component of the oral contraceptive pill.

Adolescent↗
PubMed1993

Long-interval treatment regimen with a desogestrel-containing oral contraceptive.

A randomized multicenter study was performed in order to investigate the acceptance of a low-dose OC (30 micrograms of ethinyloestradiol and 150 micrograms of desogestrel), using a 9 weeks on and 1 week off schedule (prolonged regimen, n = 198), compared to a traditional 3 weeks on, 1 week off schedule (standard regimen, n = 96). Haemoglobin and blood pressure remained the same in both groups during the study. No significant differences were found in body weight changes between the two groups. There was significantly more breakthrough bleeding and spotting in the group with prolonged regimen than in the group with standard regimen, but both breakthrough bleeding and spotting decreased during the trial. Irregular bleeding was significantly less in women who were already using OC, compared to "new starters." No serious side effects occurred. Significantly more women stopped the trial because of bleeding problems in the group with prolonged regimen, while there were significantly more women who stopped the trial because of headache in the group with standard regimen. After completing 12 months, or after premature withdrawal from the study, each women completed a questionnaire. Sixty-three per cent of the women preferred the studied alternative and twenty-six per cent preferred the traditional OC.

Adolescent↗
PubMed1993

Ultrasound evaluation of ovarian activity under oral contraceptives.

The trend towards changing the composition of the contraceptive pill in order to decrease side effects might lead to increased ovarian activity. This may decrease reliability. Therefore, a non-invasive method for monitoring the suppressive effect of the pill on ovarian function is warranted. The aim of the present study was to investigate whether or not diagnostic ultrasound might be the method of choice for studying residual ovarian activity during pill use. In 89 women on a low-dose oral contraceptive (30 mcg ethinyl-estradiol (EE)/75 mcg gestodene), the first two months of pill-intake were monitored extensively with diagnostic ultrasound. The study revealed that only one ultrasound investigation was needed during the first week of pill intake to discover all relevant cases of residual ovarian activity. Follow-up investigations are needed to quantify this activity more specifically.

Contraceptives, Oral↗
PubMed1993

Copper release from copper intrauterine devices removed after up to 8 years of use.

We studied the copper-releasing ability, weight and microscopic appearance of 2 copper-bearing intrauterine devices (IUDs), Copper-T Cu 200 (CuT) and Nova-T Cu 200 Ag (NovaT), after they had been in utero for up to 8 years. In addition, we studied whether IUDs removed from pregnant women showed different copper release. We found that IUD weight was a linear, negative function of duration of use, and that less than 20% of total copper would be released over a period of 8 years. The average copper-releasing ability was significantly higher for CuT than for NovaT (82.6 +/- 6.4 vs. 42.7 +/- 2.6 micrograms/day). The copper release was constant and thus unrelated to duration of use. Copper-releasing ability was similar in IUDs removed from pregnant and non-pregnant women. Fragmentation or minor defects only occurred in 3% of the IUDs and no correlation was found between deposits or corrosion and copper release rates. We conclude that CuT and NovaT both have constant copper release for at least 5-6 years and that the useful life-span probably can be prolonged to 6-8 years or more.

Copper↗
PubMed1993

The long-term effects of copper surface area on menstrual blood loss and iron status in women fitted with an IUD.

The long-term effects of copper surface area on menstrual blood loss (MBL) and iron status (hemoglobin, hematocrit, red cell count and indices, and serum ferritin) were evaluated in 25 healthy women who were observed for a period of 3 years following insertion of an intrauterine device. MBL was determined objectively by the alkaline hematin method. The women (mean age 37.2 +/- 1.6 yr, range 27-46 yr) were fitted with a Multiload intrauterine device (IUD) with a copper surface area of either 250 mm2 (MLCu-250, n = 13) or 375 mm2 (MLCu-375, n = 12). MBL prior to IUD insertion was 55 +/- 8 ml for women subsequently fitted with a MLCu-250 and 59 +/- 9 ml for women fitted with a MLCu-375. An increase in MBL was recorded at all measurement points following IUD insertion (MLCu-250/MLCu-375: 3 months: 55/49%; 6 months: 58/49%; 12 months: 64/41%; 24 months: 55/49%; 36 months: 47/39%, NS). There were no significant differences in iron status parameters before IUD insertion between groups nor were there any significant changes recorded in any of these parameters after IUD insertion. Our findings that the increase in copper surface area from 250 mm2 to 375 mm2 had no effect on MBL were thus substantiated by the hematological findings. Based on the results of the present study, women from developed countries apparently tolerate an increased MBL of approximately 45% without developing anemia. Iron stores were unchanged indicating an adequate adaptive increase in intestinal iron absorption.

Adult↗
PubMed1994

Antichlamydial activity of cervical secretion in different phases of the menstrual cycle and influence of hormonal contraceptives.

Cervical secretion from three groups of asymptomatic women, either being oral contraceptive (OC) non-users or users (ethinylestradiol plus desogestrel or levonorgestrel), was tested for its capacity to prevent Chlamydia trachomatis, serotype I, from forming inclusions in cycloheximide-treated McCoy cells. The non-user groups were comprised of 12 women from whom cervical secretion was collected twice weekly during the menstrual cycle and 15 women from whom cervical secretion was collected once or twice weekly. The OC users included 66 women from whom cervical secretion was collected once or twice during their menstrual cycle. Cervical secretion from the non-users produced a decrease in the chlamydial inclusion count by 70%-90% during the first 3 weeks of the menstrual cycle, as compared with the fourth and fifth week when the reduction was 56%-68% (p < 0.001). Secretion from the OC users showed a more effective decrease in the inclusion count during the first 3 weeks of the menstrual cycle, as compared with samples obtained at the fourth and fifth weeks, i.e. 15%-35% vs. 20%-25% (p < 0.001). Cervical secretion of the non-users as compared to the users produced a significant decrease in the inclusion count, viz. 70%-90% vs. 15%-35% (p < 0.001) during the first 3 weeks as compared with 56%-68% vs. 20%-25% (p < 0.001) in the fourth or fifth week. The study suggests that natural resistance to genital chlamydial infection can differ during the menstrual cycle and it may be influenced by oral contraceptive use.

Antibodies, Bacterial↗
PubMed1994

The use of contraceptive methods among women seeking a legal abortion.

In a simple random sample study of 404 women 20 to 29 years of age, 201 applying for abortion and 203 continuing their pregnancies, all were interviewed personally and requested to complete a questionnaire. The aim of the study was to analyse the use and experience of contraceptives among the abortion applicants in this age group, and to compare their experience with that of women in a matched control group. The most important reasons given for desisting in the use of contraceptives were the experience of side effects, worry about the side effects, and the "human failure" factor involved even with methods of contraception such as pills, which generally are regarded as safe. This study demonstrates that women living alone without any permanent relationship, having a strained economy or having previously had an abortion, need particular and detailed contraceptive advice plus continued close follow-up. To improve the continuation rate, precise contraception counselling focusing on both positive and adverse effects to reduce worry seems essential.

Abortion Applicants↗
PubMed1994

Hemostasis profile and lipid metabolism with long-interval use of a desogestrel-containing oral contraceptive.

Thirty healthy women, aged 18 to 37, were randomly allocated to treatment with a desogestrel-containing oral contraceptive, with 20 women using a nine-week on, one-week off regimen, and 10 women using the traditional regimen. At 0, 3 and 12 months, blood samples were drawn for liver proteins, lipoproteins and hemostatic variables. No significant changes were observed between the two regimens. Sex hormone binding globulin (SHBG) and corticosteroid binding globulin (CBG, transcortin) were increased two- to four-fold, as a measure of estrogenicity. Minimal changes occurred within the lipoprotein cholesterol fractions, whereas there were some increases within the lipoprotein triglyceride fractions. Among the hemostatic variables, there were significant increases of fibrinogen, factor VII and thrombin/antithrombin III (TAT) complex. The coagulation inhibitors, antithrombin III, protein C and protein S, were essentially unchanged. A decrease of both tissue plasminogen activator antigen (t-PA) and tissue plasminogen activator inhibitor activity (PAI activity) of the fibrinolytic system was observed. A nine-week regimen does not seem to alter lipid metabolism and coagulation more than a three-week regimen.

Adolescent↗
PubMed1994

Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age.

A comparative study of two low-dose oral contraceptives, gestodene (GES) 75 mcg/ethinyl oestradiol (EE) 30 mcg and desogestrel (DES) 150 mcg/EE 20 mcg, was conducted in women over 30 years of age. This randomised, open-label study was organised in Denmark, Italy, New Zealand and United Kingdom. A total of 505 women received GES/EE and 501 received DES/EE for 6 consecutive menstrual cycles. The two groups were comparable in terms of demographic and gynaecologic characteristics at baseline. However, the menstrual flow length was slightly longer in the GES/EE group before the start of the treatment. The mean age (+/- SD) was 35 +/- 4 years in the GES/EE group and 35 +/- 5 years in the DES/EE group. The subjects in the GES/EE group contributed data for a total of 2800 cycles and those in the DES/EE group, data for 2796 cycles. There were no pregnancies on medication with either preparation. The results showed that there were significantly more normal cycles in the GES/EE group for cycles 1 to 6. Irregular bleeding between withdrawal bleeds occurred in 10% of GES/EE and 18.5% of DES/EE cycles. Absence of all bleeding was reported in 29 (1%) and 63 (2%) cycles, respectively. The incidence of missed pills was low in both groups (11% of cycles). No significant differences were observed in cycle length or withdrawal bleeding episode length. Withdrawal bleeding mean intensity was statistically significantly greater with GES/EE. However, for both preparations, the mean intensity was close to light bleeding. No clinically significant differences were noted in weight, blood pressure, Papanicolaou smears or laboratory data. Sixty-eight (13.5%) subjects in the GES/EE group and 64 (12.8%) in the DES/EE group discontinued before the end of the study. Among them, 37 (7%) and 40 (8%) in the respective groups withdrew because of adverse reactions. There was no difference between groups in terms of primary reasons for withdrawal. The most frequently reported complaints that led to discontinuation in both groups were headache, nausea and metrorrhagia. Breast tenderness led to the discontinuation of 1 subject in the GES/EE group and 3 in the DES/EE group. These results show excellent cycle control, efficacy and very low rate of side effects with both GES/EE and DES/EE. These low-dose oral contraceptives could be well suited to healthy nonsmoking women requiring contraception up to the age of menopause.

Adult↗
PubMed1995

The effect of small doses of progesterone released from two types of vaginal rings on ovarian activity and bleeding patterns during the first postpartum year.

A total of 20 breastfeeding women used progesterone-releasing vaginal rings for up to 12 months. The women were divided into two groups, one (n = 9) using rings with an initial release rate of 5 mg/24 h, the other (n = 11) with a release rate of 20 mg/24 h. Individual women started to give breast milk supplements and ceased to breastfeed after various periods of time. Urinary estrone and pregnanediol glucuronide levels were measured by radioimmunoassay three times weekly during the entire trial. Individual diary cards were used to register bleeding and spotting. A significantly higher concentration of pregnanediol glucuronide was seen when the 20 mg/24 h ring was used in the lactation period, in comparison with the 5 mg/24 h ring. In the post-lactation period, pregnanediol glucuronide levels dropped when the 20 mg/24 h ring was used. Estrone glucuronide levels increased after the termination of breastfeeding, indicating an enhanced suppression of ovarian activity in the lactation period with both rings. Although the degree of suppression was dose-related, both rings were likely to offer a sufficient contraceptive effect in the lactation period. No significant changes were observed when milk supplements were added to breastfeeding. The use of the 20 mg/24 h ring resulted in a much better bleeding pattern (significantly less bleeding days) than the 5 mg/24 h ring during the lactation period. In the post-lactation period, the 20 mg/24 h ring the bleeding because much worse than in the lactation period.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravaginal↗
PubMed1995

Use and misuse of oral contraceptives: risk indicators for poor pill taking and discontinuation.

The contraceptive efficacy of oral contraceptives (OCs) depends on their proper and continued use, particularly with lower estrogen preparations. However, few studies have examined why women miss pills or discontinue OCs, and those that do tend to be small and to focus on adolescents. To address the issues of poor OC compliance and early OC discontinuation, we analyzed OC use in a convenience sample of 6,676 women between the ages of 16 and 30 from Denmark, France, Italy, Portugal, and the United Kingdom. Logistic regression was used to examine the independent effect of each factor. Poor compliance was associated with a lack of established routine for pill-taking (relative risk [RR] = 3.3), failure to read and understand written materials that came with the OC package (RR = 2.2), not receiving adequate information or help about OCs from their health care provider (RR = 1.5), and occurrence of certain side effects, including hirsutism (RR = 2.1), nausea (RR = 1.4), bleeding irregularities (RR = 1.3), and breast tenderness (RR = 1.2). Women who were inconsistent OC users, missing one or more pills per cycle, were almost three times as likely to experience an unintended pregnancy while using OCs than were women who took their OCs consistently. Factors that predicted early discontinuation (women who wished to continue contraceptive protection but discontinued OC use) were primarily side effects, including nausea (RR = 2.1), bleeding (RR = 1.9), breast tenderness (RR = 1.8), mood changes (RR = 1.8), and weight gain (RR = 1.4).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1995

The influence of the Gyne-T 380S IUD on menstrual blood loss and iron status.

The influence of the Gyne-T 380S intrauterine contraceptive device (IUD) on menstrual blood loss (MBL) and iron status (hemoglobin, hematocrit, red cell count and indices, and serum ferritin) was evaluated. MBL was determined objectively by the alkaline hematin method in 18 women (mean age 37.1 +/- 1.6 yr, range 22-46 yr) before and 3, 6 and 12 months after insertion of a Gyne-T 380S IUD. MBL prior to IUD insertion was 59 +/- 8 ml and increased to 91 +/- 11 ml (p < 0.01) 3 months after insertion. MBL then remained largely unchanged during the remainder of the observation period (6 months, 94 +/- 12 ml; 12 months, 92 +/- 13 ml). The percentage increase in MBL at the respective measurement points ranged between 54 and 59% which is comparable with previous reports regarding the increase in MBL associated with the use of a copper IUD. There were no significant changes recorded in iron status parameters during the 12-month observation period following IUD insertion. Based on the results of the present study, women from developed countries apparently tolerate an increased MBL of approximately 55% without developing iron deficiency anemia. Iron stores were unchanged indicating an adequate adaptive increase in intestinal iron absorption.

Adult↗
PubMed1996

Reduced serum cholecystokinin and increase in body fat during oral contraception.

This investigation was undertaken to explore a possible role of the "satiety peptide" cholecystokinin and some other gastrointestinal hormones for changes in appetite and weight during oral contraception. Ten young healthy women attending a youth health care center for contraceptive counseling volunteered for the study. A standardized meal test was used for recordings of appetite and gastrointestinal hormone response before and after 5 months of treatment with a monophasic combined oral contraceptive. Body fat was calculated from measurements of skin-fold thickness. Oral contraceptives caused a suppression of basal levels of serum cholecystokinin, which was correlated to an increase in body fat. Meal-related response of cholecystokinin and appetite were not affected. Serum levels of gastrin and insulin were also unchanged, whereas triglycerides and postprandial glucose levels were elevated. The results suggest a role of cholecystokinin in regulation of body composition. Cholecystokinin stimulates the release of insulin and stimulates lipolysis in adipose tissue. Reduced cholecystokinin levels may, therefore, be related to mild impairment of glucose tolerance and promote body fat storage during oral contraception.

Adipose Tissue↗
PubMed1996

Effects of a sequential regimen of mifepristone-medroxyprogesterone acetate on ovarian function, endometrial development and hormonal parameters.

The efficacy of a low dose of mifepristone, 5 mg/day for the first 15 days of the menstrual cycle, followed by medroxy-progesterone acetate (MPA), 10 mg/day for the next 13 days, for inhibiting ovulation was assessed in ten volunteers who were treated for three successive cycles. Hormonal determinations in blood and urine samples, ovarian ultrasonography and an endometrial biopsy taken on day 21-24 of the third treatment cycle were used to monitor the cycles. Ovulation was confirmed in 11 of the 30 treated cycles and, in these 11, the LH peak and follicular rupture occurred during MPA treatment periods. Out of 19 anovulatory cycles, 16 had no increase in progesterone levels and another 3 developed a luteinized unruptured follicle. Progestin administration induced secretory changes in the endometrium, but irregular or delayed development was found. Regular withdrawal bleeding occurred in all subjects. These data indicate that the sequential regimen can suppress ovulation while maintaining regular bleeding but increased efficacy is needed for phase II clinical trials.

Adult↗
PubMed1984

The evidence for urban turnaround in Norway.

"In Norway the post-war period has been characterised by centralisation of population--nationally, regionally and locally. In the mid-sixties the process slowed down and in the seventies the proportion of the population living in the nine urban regions declined. Only on the local level does the concentration process continue, but less drastically than before. With a significant exception, Gibbs' model of population concentration gives an adequate description of the changes."

Demography↗
PubMed1981

The first abortion - and the last? A study of the personality factors underlying repeated failure of contraception.

The causes leading to a second abortion were outlined in a psychological study comparing 30 women expecting a second abortion with 29 women who had successfully prevented conception after a first abortion. It was found that both groups improved their contraceptive practices after the first abortion. However, while the latter group continued with their improved practices, the former group went back to the earlier inefficient or non-existent contraceptive behavior. The inability to improve contraception in the long run was not related to differences in educational level or knowledge about contraceptive techniques but to the developmental level of personality structures. The women expecting their second abortion rated lower in control of impulsivity, emotional balance, realism, self-esteem and stability of life as well as capacity for more integrated personal relationships. The differences in personality development and consequently in the capacity for long-term contraception were found to be due to growth conditions in childhood.

Abortion, Legal↗
PubMed1982

The effect of various oral contraceptive combinations on premenstrual symptoms.

The influence of different oral contraceptives on premenstrual complaints was examined in 191 randomly selected women from an urban population. Premenstrual depression and abdominal swelling was significantly more common in women taking oral contraceptives containing the progestogen component lynestrenol than those containing norgestrel. The reason for this difference is discussed. A deficiency of pyridoxine which affects tryptophan metabolism can explain the difference in premenstrual depression. However, it should be emphasized that the system which controls neuro-endocrine balance is extremely complicated and does not at the present time permit any definite conclusions regarding the influence of oral contraceptives on mental complaints.

Adolescent↗