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Clinical performance of copper-T-200, multiload-250 and Nova-T: A comparative multicentre study.

A randomized multicentre study of Copper-T-200 (CuT), Multiload-250 (ML) and Nova-T (NoT) was conducted to evaluate the clinical performance of these three IUDs in the hands of general practitioners with varying experience in the different insertion techniques. After 36 months of use a total of 19,821 treatment cycles was accumulated. The continuation rate was 69.7% for CuT, 60.9% for ML and 61.8% for NoT. The cumulative expulsion rate after 36 months was 5.0% and equally distributed among centres and types of IUD. Removal for medical reasons was 11.4% and also equally distributed among the centres and the types of IUD. The pregnancy rate was insignificantly higher for the NoT compared with the two other types.

Clinical Trials as Topic↗

Sexual and reproductive life events in relation to duration of oral contraceptive use.

In order to disclose differences between users and non-users of oral contraceptives (OC), 620 women aged 15-54 were invited to participate in an in depth interview about sexual, contraceptive, and reproductive life events. Of the 585 women who participated, 459 were consecutive gynecological in- or outpatients, and 126 were selected from visitors in general practice. Data was analysed by multivariate test statistics. After correction for present age and social class, the duration of use of OC (DOC) among women 15-34 years of age correlated negatively to age at menarche and coital debut and positively to number of sexual partners, oral-genital sexual practice, and number of pelvic inflammatory diseases. Among women over 35, DOC was positively associated only to cigarette smoking. No correlation was found to coital frequency (whether earlier, present or during pregnancy or menstruation), number of births and abortions, or to social classification. In epidemiological research on benefits and risks of oral contraceptives, confounding influence of one or more variables is of crucial importance. The present findings point at sexual and life-style habits as potential confounders in the study of OC and associated diseases.

Adolescent↗

Patterns of bleeding and body iron stores during the use of a levonorgestrel-releasing intracervical device.

A levonorgestrel-releasing intracervical device (LNG-ICD) was inserted in 198 women. The subjects registered bleeding and spotting days on special cards, which were analyzed after one year of treatment. Bleeding and spotting days gradually declined from sixteen during the first month to seven during the seventh month, and they remained under that level until the end of the first year. There were more days of spotting than bleeding. Eleven per cent of the subjects experienced at least 90 days non-bleeding interval during the first year of LNG-ICD use. There were no significant changes in blood hemoglobin concentrations during the first four years of LNG-ICD use. The mean serum ferritin concentration increased from 38 micrograms/l at the beginning to 97 micrograms/l at the end of the fourth year.

Adolescent↗

The influence of copper intrauterine device on fatty acid composition of cervical mucus lecithin.

Fatty acid composition of lecithin was analysed in midcycle cervical mucus obtained from 19 women using a copper intrauterine device (Cu-IUD) and 16 controls. In both groups, palmitic (16:0) acid was the predominant fatty acid and oleic (18:1) acid the second largest component. In women using a Cu-IUD, levels of myristic (14:0) acid were significantly lower, while levels of linoleic (18:2) and docosahexaenoic (22:6) acid were significantly higher than in controls. These changes in fatty acid composition could not be related to duration of IUD use and were very similar to those observed in women with primary unexplained infertility, suggesting that the Cu-IUD-induced modification of fatty acid pattern in midcycle mucus lecithin may be part of the contraceptive mechanism of action.

Adolescent↗

Acceptability of an experimental intracervical device: results of a study controlling for selection bias.

We analyzed baseline and 12-month follow-up interview data from 98 women who had volunteered to use an experimental intracervical device (ICD) and from 155 women who had been randomly assigned to two control groups, the levonorgestrel-releasing intrauterine device (LNG-IUD; N = 86) and the copper Nova-T IUD (N = 69). All participants were clinic patients in Helsinki, Finland. Initial analysis of 12-month discontinuation data indicated that a significantly higher percent of ICD users (22.4) discontinued their device than did either LNG-IUD (7.0) or Nova-T (8.7) users. However, we were no longer able to detect significant differences in discontinuation after controlling for baseline variables that assessed predisposition to be dissatisfied with contraception in general. Adjusted probabilities of discontinuing the ICD, LNG-IUD, and Nova-T were 11.8%, 6.2% and 7.9%, respectively. These data indicate that the ICD is likely to be acceptable to Helsinki clinic patients; moreover, they suggest a definite place for hormonal intrauterine devices in the contraceptive armamentarium. Most importantly, the methodology used here can be generalized to acceptability studies of other contraceptive devices and drugs undergoing Phase I and early Phase II clinical trials (in situations where randomization may not be feasible) in order to identify and control for the bias introduced by nonrandom assignment procedures.

Adolescent↗

Vascular changes in the human endometrium following the administration of the progesterone antagonist RU 486.

Eleven healthy women were assigned to one of two groups. They received 50 mg RU 486 orally per day either on cycle days 7 to 10 (preovulatory group n = 5) or on cycle days 20 to 23 (postovulatory group, n = 6). An endometrial biopsy was taken on the fourth day of the RU-treatment in the preovulatory group and on the second (n = 2) or fourth (n = 4) treatment day in the postovulatory group. Biopsies from 34 untreated women representing matched samples from early and mid preovulatory phase (n = 10) and mid and late postovulatory phase (n = 24) were used as control. The ultrastructure of the endometrial capillaries was investigated by morphometric methods. The administration of RU 486 during the preovulatory phase did not modify the vascular structure. However, when given in the postovulatory phase, necrosis occurred in the capillary endothelial cells with and without regressive changes of the adjacent stroma. The area and diameter of the capillary lumen and the area of the adventitia was smaller than in the control material (p less than 0.01). The result of the study suggests that RU 486, when administered in the postovulatory phase, directly affects the capillary vessels of the endometrium.

Adult↗

Contraception in Sweden.

In 1987, a survey of contraceptive use, knowledge and attitudes was conducted in Sweden by the International Health Foundation (IHF) as part of a multi-country study that has so far involved six other countries in Europe. The women involved, who were aged 15-44, completed a standard questionnaire. The overall percentage use of contraceptive methods, especially the reliable ones, was found to be high (95%). Oral contraception was the most frequently used method, followed by barrier methods and the intrauterine device (IUD). Contraceptive methods were chosen or abandoned mainly because of health reasons and better reliability. Knowledge of fertility proved to be generally good. Medical methods such as oral contraceptives and IUDs were associated with health hazards. In the case of the pill, fears of cardiovascular risks, thrombosis and cancer were widespread, while infection risk and menorrhagia were the most frequently quoted perceived disadvantages of the IUD. Indeed, these two methods suffer from a very negative image among Swedish users.

Adolescent↗

Pharmacokinetics of 3-keto-desogestrel and ethinylestradiol released from different types of contraceptive vaginal rings.

Pharmacokinetics of 3-keto-desogestrel and ethinylestradiol released from contraceptive vaginal rings (CVRs) with different release rates (75/15, 100/15 and 150/15 micrograms 3-keto-desogestrel/ethinylestradiol daily) were investigated in two studies in young healthy female volunteers. As reference, an oral preparation containing 150 micrograms desogestrel and 30 micrograms ethinylestradiol (MarvelonR tablets) was also administered to the volunteers. To assess the disposition parameters of 3-keto-desogestrel and ethinylestradiol, some of the volunteers were additionally given an i.v. preparation containing 150 micrograms 3-keto-desogestrel and 30 micrograms ethinylestradiol. Serum levels obtained with CVRs showed an initial increase during the first three days, followed by a plateau decreasing only slightly during the remainder of the treatment period. Mean plateau levels (+/- s.d.) of 3-keto-desogestrel were 2.3 +/- 0.9, 2.8 +/- 1.1 and 3.8 +/- 1.1 pmol/ml for CVR 75/15, 100/15 and 150/15, respectively. Mean plateau levels of ethinylestradiol were 184 +/- 75, 262 +/- 102 and 233 +/- 102 pmol/l, respectively. The in vivo release rates of 3-keto-desogestrel and ethinylestradiol from the CVRs were in good agreement with the in vitro release rates. For both steroids the bioavailability from the CVRs was approximately 1.2 times higher than that from the tablets. The 3-keto-desogestrel serum levels were found directly proportional to the release rates within the range studied (75-150 micrograms/day). For ethinylesteradiol the intra-individual variation in steady-state levels was too large to draw pertinent conclusions.

Administration, Oral↗

Modern oral contraceptives and dysmenorrhoea.

Women with primary dysmenorrhoea not sufficiently helped by triphasic oral contraceptives (OCs) were offered a modern, low-dose monophasic OC containing 30 micrograms of ethinylestradiol and 150 micrograms of desogestrel. The study shows that for these women, the monophasic pill was the better alternative. The fact that 19 of 23 women who continue treatment on the monophasic OC indicates that this type of pill may be chosen as the first alternative for women with primary dysmenorrhoea.

Adolescent↗

IUD (Nova-T) insertion following induced abortion.

In a prospective study, 86 women who had an IUD (Nova-T) inserted immediately after induced abortion were compared to 95 abortion patients who started another contraception (control I). Additionally, the rate of complications following IUD insertion in a Family Planning Clinic (control II) were studied in 83 non-pregnant women. The overall infection rate for post-abortion patients was 4.4% (5.8% in the study group, 3.2% in control I). No infections were observed in control group II. Confidence limits (95%) for the three groups were overlapping. Among the women in the study group, bleeding and pain were not more frequent, but if one of these complications occurred, it tended to be more serious and the duration was longer. The number of days before resumption of work after abortion was 3-4 days in both abortion groups. After three months, the continuation rate was 83% (71 of 86) in the study group, 76% (72 of 95) in control I and 93% (77 of 83) in control II. Sixty-nine of the 181 women admitted for legal abortion had been admitted for the same reason previously. In this study, the recurrence rate after 12 months was 0% in the study group and 4.2% (4 of 95) in control group I. The insertion of an IUD at the time of abortion seems to be an effective and acceptable solution to the problem of recurrent abortion.

Abortion, Induced↗

The influence of copper surface area on menstrual blood loss and iron status in women fitted with an IUD.

The influence of copper surface area on menstrual blood loss (MBL) was evaluated in 34 healthy women (mean age 36.4 +/- 1.4 yr, range 27-46 yr), who were fitted with a Multiload intrauterine device (IUD) with either 250 mm2 (MLCu-250) or 375 mm2 (MLCu-375) copper wire. MBL prior to IUD insertion was 54.4 +/- 10.3 ml for women subsequently fitted with a MLCu-250 and 56.9 +/- 6.9 ml for women fitted with a MLCu-375. An increase (p less than 0.01) in MBL was recorded 3 months after IUD insertion for both the women fitted with a MLCu-250 (86.4 +/- 10.3 ml) and a MLCu-375 (81.1 +/- 8.3 ml). This increase in MBL remained unchanged throughout the study period of one year. At no point were there any significant differences in MBL or increase in MBL between women fitted with a MLCu-250 or MLCu-375. There were no significant differences in serum ferritin, blood hemoglobin, hematocrit or erythrocyte indices before IUD insertion in the women grouped according to type of IUD, nor were any significant changes recorded in any of these parameters after IUD insertion. Thus, our findings that the increase in copper surface area from 250 mm2 to 375 mm2 had no effect on MBL were also substantiated by the hematological findings.

Adult↗

The influence of different combined oral contraceptives on the prevalence and severity of dysmenorrhea.

The influence of different oral contraceptives (OC) on the prevalence and severity of dysmenorrhea was investigated longitudinally (from age 19 to 24 years) in a representative sample of young women from an urban Swedish population. The women were grouped according to the type of OC used at the time of assessment: monophasic OC with low gestagen activity; progestogen-dominated monophasic OC; triphasic OC; neither OC nor an intrauterine device (IUD). At the age of 19 years, the severity of dysmenorrhea was lower in users of monophasic OCs with low gestagen activity (p less than 0.05) and users of progestogen-dominated monophasic OCs (p less than 0.001) compared to women who used neither OC nor an IUD. At 24 years of age, the severity of dysmenorrhea was lower in users of monophasic OCs with low gestagen activity (p less than 0.001), users of progestogen-dominated monophasic OCs (p less than 0.001) and users of triphasic OCs (p less than 0.001), compared to women who used neither OC nor an IUD. The severity of dysmenorrhea in women who did not use an OC or IUD when 19 years old was reduced in the same women who used OCs when 24 years old, compared (p less than 0.001) to women who still used neither an OC nor an IUD. There were no significant differences in the prevalence and severity of dysmenorrhea between the users of monophasic OCs, irrespective of progestagen activity, and users of triphasic preparations.

Adult↗

Contraception survey: Denmark 1988.

In 1988 a survey** was conducted in 1,033 women living in Denmark, whose ages ranged from 15 to 44 years. The main aims of the study were to identify the influence, if any, of demographic and socioeconomic factors on contraceptive use and to assess the women's knowledge of selected facts concerning their own fertility. The study's additional objectives were to gain insight into factors influencing communication on the subject of contraception, such as advice obtained from professional counsellors, general information dissemination and discussion between partners, and to investigate women's attitudes and opinions regarding contraceptive methods and their use. The results are discussed in relation to the findings of other studies on the use of contraceptives both worldwide and in a number of European countries. The Danish findings are also examined in the context of possible action to reduce the relatively high rate of legally induced abortions in Denmark.

Adolescent↗

Clinical results with subcutaneous implants containing 3-keto desogestrel.

Eight healthy women using one Silastic implant of 30 mm length filled with 3-keto desogestrel, the active metabolite of desogestrel, were studied for 36-664 days. The release rate of 3-keto desogestrel was quite constant and around 30 micrograms/day. No ovulations occurred. One woman was amenorrheic, while the others had different bleeding patterns, often with periods of spotting. No other side effects were recorded. The mean plasma levels of 3-keto desogestrel were 0.9 nmol/l after 1 month and 0.5 nmol/l after 12 months. 3-Keto desogestrel was less effective than testosterone, estradiol or levonorgestrel in displacing 3H-dihydrotestosterone from SHBG. It is concluded that contraception with 3-keto desogestrel delivered through an implant is a promising method for further investigation. With a single implant we found a duration of at least one year.

Binding, Competitive↗

Use of oral contraceptives in relation to dietary habits and alcohol consumption.

The relationship between oral contraceptive (OC) use, dietary habits and alcohol consumption in young women was studied in Tromsø, Norway. A total of 5,800 women aged 20-39 years answered a questionnaire in 1986/1987. Women with long-term duration of OC use reported more frequent intake of meat for dinner, preferred low-fat milk and drank less coffee. For other food items such as intake of fats, fish, fruit and vegetables, no differences were found. Strong associations were found for alcohol consumption, with increasing frequency of use among long-term users of OCs. These results are discussed in relation to the possible association between OC use and breast cancer in young women.

Adult↗

A longitudinal study of contraception and pregnancy outcome in a representative sample of young Swedish women.

The prevalence of contraception and pregnancy history in the same women, aged 19 and 24 years, was assessed in a longitudinal cohort study by means of a postal questionnaire. A one-in-four random sample of all the women born 1962, resident in the city of Göteborg in 1981, was obtained from the population register (n = 656). The response rate was 91%. Respondents from 1981 were re-assessed in 1986 (response rate: 83%). The respondents from 1986 (n = 488) represent 74% of the original sample from 1981. Contraceptive usage in the same women aged 19 and 24 years (in brackets) was as follows: Oral contraception (OC) 47% (51%); intrauterine device 3% (11%), p less than 0.01; barrier methods 11% (11%); depot gestagen 0 (0.2%); no contraception 39% (26%), p less than 0.05. OCs were being taken or had been taken by 89%. Reasons given for cessation of OC were as follows: Contraception not required 10% (15%); fear of OC 26% (29%); menstrual disorder 17% (14%); weight increase 18% (10%), p less than 0.05; mental side effects 15% (9%); desire to become pregnant 7% (17%), p less than 0.01. Pregnancies (n = 362) were reported by 194 (43%) of the women. 44% of the pregnancies terminated in legal abortion. The medical complication rate following legal abortion was 15%. Thus, despite the availability of effective contraception, the ratio of legal abortions to live births was high. Fear of side effects was the commonest reason for discontinuing OC.

Adult↗

Progesterone-releasing vaginal rings for use in postpartum contraception. II. Pharmacokinetic profiles in women.

Vaginal rings releasing progesterone with 3 different initial release rates (5, 8 and 20 mg/day) were used by 11, 10 and 10 women, respectively. The period of insertion was 90 days. The 5 and 8 mg/day rings consisted of a core loaded with progesterone, the 20 mg/day ring contained progesterone homogeneously distributed throughout the mass of the ring. Notwithstanding these differences, the total progesterone levels (areas under curve) were directly related to the release rates. So were the rates of decrease of progesterone levels during the 90 days of insertion of the ring. They were 25, 31 and 47% for the rings releasing 5, 8 and 20 mg/day, respectively.

Administration, Intravaginal↗

The influence of a low-dose combined oral contraceptive on menstrual blood loss and iron status.

The influence of a low-dose combined oral contraceptive (ethinyl estradiol 30 micrograms + desogestrel 0.15 mg) on menstrual blood loss (MBL) was evaluated in 20 healthy, young women. MBL prior to commencing oral contraception was 60.2 +/- 5.6 ml (range 22-116 ml), and decreased (p < 0.001) to 36.5 +/- 5.2 ml (range 7-80 ml) and 33.7 +/- 4.1 ml (range 5-70 ml) after 3 and 6 months' oral contraceptive medication, respectively. The reduction in MBL during oral contraception was most apparent during the first two days of menstruation. Five women had an MBL > 80 ml prior to commencing oral contraceptive medication. In all of these women, MBL during the 6th menstrual period after commencing oral contraception was < 80 ml. All the women included in this study had a normal blood hemoglobin concentration, hematocrit and erythrocyte indices and there were no significant changes in these variables during the course of the study. Serum ferritin concentration prior to commencing oral contraception was 44.2 +/- 9.0 micrograms/l and was largely unchanged after 6 months' oral contraception (39.7 +/- 6.3 micrograms/l). On admission to the study, two women had a serum ferritin < 10 micrograms/l, indicative of low iron stores. Both these women had an MBL > 80 ml at the baseline assessment. Serum ferritin concentration increased during oral contraceptive medication in both women (from 8.5 micrograms/l to 12.0 micrograms/l and from 5.4 micrograms/l to 6.8 micrograms/l, respectively). The duration of menstruation (p < 0.01) and the number of women suffering from dysmenorrhea (p < 0.05) was reduced during oral contraception.

Adolescent↗