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Biomedical subjects

T Luukkainen

Publications and source records attributed to T Luukkainen.

At least 73 records · Page 4Linked to original sources

Clinical performance of a new levonorgestrel-releasing intrauterine device. A randomized comparison with a nova-T-copper device.

The clinical performance of two levonorgestrel-releasing intrauterine devices (IUDs) with different release rates was studied and compared with a copper-releasing Nova-T device in a randomized partly double-blind multiclinical trial. Special attention was given to patterns of bleeding, hormonal side-effects, blood pressure and body weight. The clinical acceptability of the levonorgestrel IUDs was as good as that of the copper-releasing IUD. A highly significant decrease in the amount of menstrual blood loss was seen with the levonorgestrel-IUDs, the users of which experienced fewer days of bleeding than prior to insertion. Patients suffering from dysmenorrhea experienced relief from this symptom after insertion of a levonorgestrel-IUD. Some side-effects, usually referred to as hormonal, increased during the levonorgestrel-IUD use, but did not result in higher termination rates than with the Nova-T device. No changes in body weight were recorded for the levonorgestrel-IUDs and a slight decrease in both systolic and diastolic blood pressure was found after one year of use. No infections were recorded.

Adolescent↗

Tissue concentrations of levonorgestrel in women using a levonorgestrel-releasing IUD.

Thirteen women who were scheduled for hysterectomy volunteered for the study. Nine women had a levonorgestrel-releasing intrauterine contraceptive device inserted between 36 and 49 days prior to surgery and four women were on oral levonorgestrel treatment for 7 days prior to surgery. After the surgical removal of the uterus, samples of endometrial, myometrial, fallopian tube and fat tissue were obtained. Methods for measuring tissue concentrations of levonorgestrel were developed and the uptake of levonorgestrel by fat tissue in vitro was studied. The concentrations of levonorgestrel in myometrial, fallopian tube and fat tissue were all of the same order, of between 1 and 5 ng/g of wet weight of tissue, in both the intrauterine device group and the orally treated group. In the endometrium the levonorgestrel concentrations were many-fold higher in the intrauterine device group. The in vitro experiments showed a rapid uptake of levonorgestrel and an unsaturability of the fat tissue by the steroid at the concentrations used. The fat tissue concentrations of levonorgestrel correlated with the plasma concentrations.

Adipose Tissue↗

Coagulation factors in women using oral contraceptives or intrauterine contraceptive devices immediately after abortion.

The changes in coagulation parameters were studied in 24 women who started using microdose combined oral contraceptives immediately after first-trimester abortion. Another 24 women who had an intrauterine contraceptive device inserted at the end of the abortion procedure were studied as control subjects. In pill users, a slightly increaed tendency toward hypercoagulability was observed 1 week after abortion in terms of elevated fibrinogen and Factor VIII as well as decreased antithrombin levels. Other studies have shown that the new follicle development after first-trimester abortion starts beyond the first week. It would therefore seem that by postponing oral contraceptive use until 1 week after abortion, no decrease in the effectiveness of contraception occurs and the possible risks of hypercoagulabilty during the postabortal period can be avoided.

Abortion, Induced↗

Intrauterine contraception with levonorgestrel: a comparative randomised clinical performance study.

Two levonorgestrel-releasing intrauterine devices (IUD) with different release rates of levonorgestrel and a 'Nova-T' copper-releasing device were compared in a randomised clinical performance study. 327 women had a levonorgestrel IUD and 156 women a nova-T device inserted postmenstrually. No statistically significant differences in the reasons for termination between the three devices were found in 12 months. The continuation rates for the two levonorgestrel IUDs were 84.1 and 81.4 and for the nova-T device 87.5. Duration of menstrual bleeding and spotting was highly significantly shorter with the levonorgestrel IUDs than with the nova-T device. There were no infections.

Adolescent↗

Intrauterine contraception with Nova-T and copper-T-200 during three years.

A randomized comparative trial on the clinical performance of two copper-releasing IUDs (Nova-T and Copper-T-200) was performed simultaneously in Denmark, Finland and Sweden. After three years the cumulative pregnancy rate was 1.9 for Nova-T and 5.0 for Copper-T. This difference in efficacy was statistically significant (p less than 0.001). Copper-T had a lower expulsion rate (p less than 0.05) in the total series but not in postmenstrual insertions. Differences between the two devices in other termination rates were not statistically significant. Analysis according to age and parity demonstrated that the pregnancy rate of Nova-T was lower than that of Copper-T in every age and parity group. The pregnancy rate of Nova-T was not effected by age or parity whereas the pregnancy rate and the expulsion rate of Copper-T decreased with increasing age and parity. The removal rate because of infection decreased markedly after the first year of use for both devices. The cumulative rate of removals for infection during the three years of use was not significantly correlated to age and there was no correlation to parity. The continuation rates increased with age and parity. The continuation rates of nulli- and primiparous women were almost identical with both devices and lower than continuation rates of women with 2 or three or more children. Only 11% of the women were lost to follow-up during 36 months. Nova-T had superior effectiveness in preventing undesired pregnancies when compared with Copper-T. The performance of Nova-T is less affected by age and parity then the performance of Copper-T. The silver core in copper wire gives a prolongation of the life-span for Nova-T. For these reasons, Nova-T appears to meet the requirements for an ideal IUD.

Adult↗

Intracervical release of levonorgestrel for contraception.

Twenty-one women used a levonorgestrel-releasing intracervical contraceptive device, which was designed to release 20 microgram/ay. The devices were inserted after cessation of menstrual bleeding. Patterns of bleeding and clinical performance wer evaluated and plasma concentrations of levonorgestrel, estradiol and progesterone in selected subjects were measured by radioimmunoassay. The results of the initial 90-day treatment are presented. Levonorgestrel was detected in peripheral plasma by 30 minutes after insertion of the device. Considerable variation of plasma levonorgestrel concentrations was observed between subjects, but within each subject, the plasma level of levonorgestrel was very stable with time. Of 24 cycles monitored by blood sampling, 19 were ovulatory. One subject did not ovulate at all. During the first 30-day period of treatment, frequent intermenstrual bleeding or spotting periods occurred. Two spontaneous expulsions occurred 9 and 22 days after insertion. Both of these subjects were nulligravidas. Side-effects were few and no pregnancies occurred during the study period.

Adult↗

Contraception with subcutaneous capsules containing ST-1435. Pituitary and ovarian function and plasma levels of ST-1435.

An RIA for a new progestin, ST-1435, was developed. Plasma concentrations of this steroid were measured in three women having three subcutaneous capsules, each containing 40 mg of ST-1435. Pituitary and ovarian functions were assessed by measuring plasma levels of LH, FSH, estradiol and progesterone. Plasma profiles of ST-1435 were characterized by high and irregular peaks all the way through the study period of 7-9 months. Concentrations below 100 pg/ml were not observed, whereas the highest peaks reached concentrations of 10.1 ng/ml. Plasma estradiol concentrations remained uniformly suppressed below 100 pg/ml, thus indicating a suppression in follicle development. As judged by constantly suppressed progesterone concentrations, no ovulations occurred during the treatment. Plasma FSH concentrations remained at the upper limit of the follicular phase, and those of LH at the lower limit of the luteal phase of the normal menstrual cycle. No midcycle gonadotropin peaks were observed.

Adult↗

Levonorgestrel plasma concentrations and hormone profiles after insertion and after one year of treatment with a levonorgestrel-IUD.

Plasma concentrations of levonorgestrel, progesterone, estradiol, FSH and LH were measured in seven volunteers who had a levonorgestrel-releasing IUD inserted postmenstrually. Blood samples were collected twice weekly during a mean of 93 days immediately postmenstrually and during a mean of 41 days over the twelfth to fifteenth month of treatment. Patterns of bleeding were studied during the first year of treatment. The IUDs used were designed to release 25 micrograms/day of levonorgestrel. The mean +/- SD plasma concentration of levonorgestrel for all subjects during the first three months was 260 +/- 68 pg/ml, and 129 +/- 28 pg/ml after one year of treatment. During the initial period of blood sampling only two of the subjects ovulated, while only two did not ovulate after one year of treatment. Intermenstrual spotting occurred during the first sixty days of treatment. Three subjects developed amenorrhea at the end of the first year. All the subjects continued the use of the IUD and no pregnancies occurred.

Adult↗

Patterns of ovulation and bleeding with a low levonorgestrel-releasing intrauterine device.

Patterns of bleeding and plasma concentrations of levonorgestrel, progesterone, estradiol, LH and FSH were studied in ten volunteers who had a levonorgestrel-releasing IUD inserted postmenstrually. The IUD was designed to release 12 microgram/day. All but two of the volunteers ovulated during treatment. The ovulatory cycles differed from the control cycles by being longer and by having depressed plasma progesterone levels during the luteal phases. Intermenstrual spottings occurred frequently during the first sixty days of treatment. No pregnancies occurred during the course of the study.

Adult↗

Silastic implants releasing estrone in the treatment of climacteric complaints.

A study on continuous low-dose estrone treatment achieved with two different silastic implants is presented. In the study estrogen treatment was supplemented with the addition of progestin in three different modes of application. The measurements of plasma estrone and estradiol concentration showed a 3- to 6-fold and a 2- to 3-fold increase, and that of FSH a decrease of 25%. The measurements of plasma estrone gave concentrations of 200-400 pg/ml and plasma estradiol was 70-200 pg/ml with uncovered estrone-releasing implants after 4 wk of treatment. The ratio of plasma levels of estrone/estradiol was around 3. The initial high estrone concentration after implantation could be eliminated by covering the rods with a thin layer of neutral silastic material. Plasma FSH and LH concentration significantly depressed when the estrone treatment was combined with levonorgestrel-releasing implants. The insertion of estrone-releasing implants alone and in combination with the cyclic treatment with norethindrone perorally, or with a norgestrienone-releasing silastic vaginal ring suppressed only the plasma FSH concentration. The climacteric complaints disappeared in a few days in every patient treated with uncovered estrone-releasing implants. Because it is easy to remove when required, the treatment with estrone-releasing silastic implants can be regarded as being safe for the patients.

Climacteric↗

An oestrone-releasing vaginal ring in the treatment of climacteric women.

Post-menopausal patients were treated with a new form of oestrogen administration by using two types of oestrone-containing vaginal rings. It was observed that oestrone was absorbed from the vagina as demonstrated by elevated plasma concentrations of oestrone (E1) and oestradiol (E2). In 3 out of 4 patients the ratio of E1/E2 was 4-5 in the first plasma samples collected after the initiation of the treatment. After the first week of treatment this ratio had dropped to 0.8-1.5, which indicates an increase and stabilization in the conversion of oestrone to oestradiol within 1 wk of treatment. The high levels of plasma oestrogens were associated with a decrease of plasma gonadotrophins and the disappearance of climacteric symptoms. The first type of ring tested resulted in a high initial burst of oestrone release, as evidenced by high concentrations of oestrone and oestradiol during the first 2 wk. In the second type of vaginal ring the high initial oestrone release was not present and the plasma oestrone and oestradiol levels were stable. The patients tolerated the treatment well, and after gaining experience, easily accepted this route of self-administration. It seems that the vaginal silastic ring is an effective steroid-delivery system in post-menopausal women. As judged by plasma oestrone and oestradiol profiles, it seems that the second type of ring was preferable to the first one as an intravaginal releasing device.

Aged↗

Two-year rates for Nova T and Copper T in a comparative study.

A random assignment comparative study between Nova T and Copper T 200 after two years of use revealed that the Nova T resulted in a significantly lower pregnancy rate than the Copper T. The study was performed simultaneously in Denmark, Sweden and Finland. The pregnancy rate in Nova T users was lower than in Copper T users in every country and in every age and parity group. There was no clinic effect in the pregnancy rate of Nova T users. The other termination rates of these two devices were not significantly different. The first segment continuation rates at two years of postmenstrual insertions were 64.7 for Nova T and 65.5 for Copper T 200. It seems that Nova T is an improved copper-releasing IUD.

Actuarial Analysis↗

Return of ovulation after abortion and after discontinuation of oral contraceptives.

The return of ovulation after abortion and discontinuation of oral contraceptives was determined by plasma progesterone measurements. Plasma samples were obtained from 67 women at 3 to 6 weeks after abortion and in two groups of postabortion women at 3 to 6 weeks after cessation of oral contraceptives. In the first of these latter two groups, 50 women started taking the pills (containing 30 microgram of ethinylestradiol and 150 microgram of levonorgestrel) immediately after abortion, and the second group of 29 women started taking the pills from the first postabortion menses. Ovulation had recurred in 34% of the women 3 weeks after abortion and in 78% of the women at 6 weeks. The return of ovulation had occured in approximately 55% at 3 weeks after cessation of oral contraceptives in both groups. At 6 weeks after cessation, approximately 85% of women had ovulated in both groups. Luteal function in these two groups was found to be equal and was significantly better in both groups than during the first postabortion cycle (P < 0.005). It is concluded that the early return of ovulation after abortion makes it necessary to commence effective contraception immediately after abortion. The immediate administration of oral contraceptives after abortion does not affect the return of ovulation after discontinuation of oral contraceptives.

Abortion, Legal↗

Plasma concentrations of levonorgestrel as a function of the release rate of levonorgestrel from medicated intra-uterine devices.

An effort was made to achieve different levels of plasma levonorgestrel (13-ethyl-17 alpha-ethynyl-17-hydroxy-gon-4-en-3-one) (Ng) concentrations by the intra-uterine admininistration of levonorgestrel-releasing intra-uterine devices (IUD). Three different models were designed to release different doses of Ng daily. Sixteen women volunteered for the study and had a Ng IUD inserted post-menstrually. The effect of the IUDs on the ovulatory pattern was studied by measuring plasma concentration of oestradiol and progesterone by radioimmunoassay. Ng plasma concentrations were also measured by radioimmunoassay. In vitro experiments to measure the release of Ng from each type of device were carried out. Although some overlapping of mean plasma levels of Ng occurred during use of the three models of the IUDs, suppression of ovulation was clearly dose-dependent. Wide variations in plasma levels of Ng were seen between individuals but quite uniform plasma levels were seen in each subject for up to one year. IUDs where in vitro release rates were equivalent to each other also resulted in wide individual variations in plasma concentrations of Ng.

Adult↗