The combined contraceptive vaginal ring and bone mineral density in healthy pre-menopausal women.

BACKGROUND: Hormonal contraceptives have been associated with various effects on the bone mineral density (BMD) of pre-menopausal women. The aim of this study was to assess the effects of a vaginal contraceptive ring on BMD in pre-menopausal women and compare them with those of non-hormonal contraceptive use. METHODS: This open-label, multicentre study used dual-energy X-ray absorptiometry to measure BMD in the lumbar spine (L(2)-L(4)) and femoral neck regions. Subjects were assigned 3:1 to receive a contraceptive ring (n = 105) or a non-hormonal contraceptive control (n = 39) and were assessed after 13 and 26 cycles of contraceptive ring treatment or 12 and 24 months of control treatment. RESULTS: No change from baseline in BMD (Z-scores) was seen in contraceptive ring users (n = 73) at either time-point. In the control group (n = 30), BMD increased slightly from baseline resulting in significant differences (P < 0.0001) between the two groups at cycle 26/month 24. These differences are not clinically relevant, although some degree of acquisition of peak bone mass might have been prevented in the contraceptive ring group. The contraceptive ring was generally well tolerated; a higher incidence of treatment-related adverse events was observed in the contraceptive ring group compared with the non-hormonal contraceptive control group. CONCLUSIONS: In healthy pre-menopausal women, 2 years of contraceptive ring use produced no changes in BMD.

Five-year clinical experiences with NOVA T 380 copper IUD.

In an open, single-group, phase III clinical trial of 5 years, the clinical performance of NOVA T 380 was investigated in three centers. The device having a higher copper surface of 380 mm(2) is a modification of NOVA T. A total of 400 voluntary women were enrolled in the study. The mean age was 31.4 years (SD 5.5) with the minimum of 18 and the maximum of 44 years. At the end of the study, 211 women had passed the 60-month visit. Cumulative discontinuation rates at the end of the first and the fifth year calculated by Kaplan-Meier estimates, were respectively as follows: pregnancy 0.5 and 1.9, expulsion 1.3 and 4.1, bleeding 4.4 and 14.0, pain 1.3 and 4.2, removal for other medical reason 1.4 and 6.4, planning pregnancy 0.8 and 13.5, and removal for other personal reason 2.4 and 11.9 per 100 users. Neither ectopic pregnancies nor episodes of pelvic inflammatory diseases (PIDs) occurred. One perforation was recorded; the calculated rate is 0.3 per 100 women (first year). The continuation rate was 88.3 and 52.5 at 1 and 5 years, respectively. In conclusion, the 5-year performance of NOVA T 380 was good compared to other "high-loaded" copper devices. Safety was acceptable over the entire study period.

Two-year clinical experience with Nova-T 380, a novel copper-silver IUD.

In 1992, an open single-group phase III clinical trial was started at three centers to investigate the clinical performance of the high copper surface area Nova-T 380, a modification of Nova-T. This report presents the interim results of the first two years of use. A total of 400 women volunteers were enrolled in the study. The mean age was 31.4 years (SD 5.5) with a minimum of 18 and a maximum of 44 years. At the cut-off date, 259 women had passed the 24-month visit. Gross cumulative life-table rates at the end of the first and second years, respectively, calculated by the Kaplan-Meier method, were as follows: pregnancy 0.5 and 1.6, expulsion 1.6 and 2.8, bleeding 4.7 and 8.7, pain 1.3 and 2.3, removal for other medical reasons 1.7 and 3.9, planning pregnancy 1.1 and 6.0, removal for other personal reasons 0.5 and 1.5, per 100 users. No ectopic pregnancies or PIDs occurred. The continuation rates were 89.0 and 75.5 at 12 and 24 months, respectively. The first two-year performance of the Nova-T 380 was good. Bleeding problems were in the same range as with devices with smaller copper surface areas. No unexpected serious adverse events were encountered.

Selection and performance of the levonorgestrel-releasing intrauterine system.

BACKGROUND: The levonorgestrel-releasing intrauterine system (LNg IUS) is a hormonal contraceptive that is used in the uterine cavity. To determine whether the reasons for choosing LNg IUS vs. copperreleasing intrauterine devices (Cu IUDs) differ and whether their performances are comparable, we carried out a retrospective study in Finland during the first years of LNg IUS use. METHODS: Gynecological and contraceptive histories of 626 LNg IUS and 626 Cu IUD users and the performance of the device were reviewed from patient records. RESULTS: Women who accepted the LNg IUS were more likely than Cu IUD acceptors to have a history of menstrual bleeding of 6 days or more (44.4% vs. 28.4%), heavy bleeding (44.8% vs. 8.4%) and moderate or severe dysmenorrhea (15.9% vs. 7.5%). In both groups, 70% of the women had used Cu IUDs earlier. However, the LNg IUS acceptors had had more side effects during previous use of CU IUDs (58.2% vs. 28.8%). They also reported more side effects that resulted in discontinuation of a previous Cu IUD (39.4% vs. 10.1%). However, the 12-month life-table continuation rates of 80.6 (SE 1.9)% vs. 83.4 (SE 1.8)% were alike. Cu IUD users discontinued the current method more often because of problems of bleeding and unwanted pregnancy. Among those women who had previously discontinued a hormonal method because of hormonal side effects, there were no differences in the continuation rates of the two groups. CONCLUSIONS: LNg IUS can be successfully used by women who cannot use a CU IUD or who have experienced hormonal side effects with oral contraceptives.

Detection of Chlamydia trachomatis infections in women by Amplicor PCR: comparison of diagnostic performance with urine and cervical specimens.

We used the Roche Amplicor PCR assay to compare urine and cervical swabs as sample material in the detection of Chlamydia trachomatis causing genital infections. The diagnostic performance of Amplicor PCR was compared with that of cell culture and the Gen-Probe PACE 2 assay with cervical specimens. If discrepant from other results, the specimens negative by PCR were diluted and reanalyzed to reveal PCR inhibitors. Of 666 patients, 39 (5.9%) were confirmed to have chlamydial infection. The respective sensitivity and specificity of Amplicor PCR were as follows: urine specimens, 82.0 and 99.7%; cervical specimens, 82.0 and 99.8%. Those for cell culture with cervical specimens were 84.6 and 100%. For the Gen-Probe PACE 2 assay, the sensitivity and specificity with cervical specimens were 79.5 and 100%, respectively. Without the effect of PCR inhibitors, the sensitivity of PCR with urine would have been 97.4%. Provided that the problems currently caused by inhibitors will be solved, the Amplicor PCR assay with urine specimens offers a tempting alternative for the diagnosis of C. trachomatis infection in women.