Clinical experience with the Cu-7 intrauterine device.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
A randomised double blind study of a plain T-shaped IUD and an active T-shaped IUD releasing 65 micrograms/day of progesterone, has been completed in four centres. A study of 1320 progesterone-releasing IUD's in parous women for 9660 women months of use significant to 18 months, gave a pregnancy rate of 1.0 +/- 0.4, expulsion of 4.7 +/- 0.6 and removals for pain and bleeding of 6.0 +/- 0.7. A detailed analysis of the menstrual bleeding patterns in these patients gave details of the number and length of bleeding and spotting episodes, count of bleeding days, and count of spotting episodes and days for four one-hundred-day reference periods. While the plain IUD contributed a significant number of intermenstrual spotting and bleeding days, the progesterone-releasing IUD contributed more spotting days.
Data obtained from questionnaires on the occurrence of dysmenorrhoea in women using IUDs inserted randomly (146 of them Progestasert and 149 Copper 7) are analyzed. In both groups a reduction in the intensity of menstrual cramps was observed over 12 months of use. Although these reductions are significant in each group, they are slightly higher in Progestasert users. However, on comparing the reduction tendencies of both groups, the difference between them is not significant. No significant differences become apparent either when comparing premenstrual and intermenstrual camps. The usefulness of simple questionnaires directed at detecting the nature of pain in currently used family planning forms for IUD users is discussed.
The relationship between the time in the menstrual cycle when a TCu-200 or Cu-7-200 is inserted and subsequent IUD-related events was evaluated. For women who had either TCus or Cu-7s inserted, the pregnancy, expulsion and medical removal rates were similar for insertions performed at any time of the menstrual cycle.
The incidences of selected events were analyzed following insertion of the PROGESTASERT intrauterine progesterone contraceptive system (IPCS) and following its reinsertion after one year of use. Reinsertion did not interrupt the stabilizing or declining trends in incidences of P.I.D., removals for bleeding/pain, removals for other medical reasons, unplanned pregnancies, moderate/severe menstrual cramps and bleeding, and premenstrual/intermenstrual cramps. Comparison of the incidence of P.I.D. in the U.S. population with postinsertion incidence of P.I.D. in IPCS users indicates that the IPCS does not increase the likelihood that a woman will have P.I.D. over the likelihood that she would have it without use of the IPCS. The incidences of expulsions and intermenstrual spotting and bleeding rose temporarily after reinsertion to about half their previous peaks and then diminished markedly within two months, reverting to the levels and favorable patterns of change established during the first year.
A non-randomised study was performed to compare the use-effectiveness of the Copper-T-200 and Nova-T intrauterine devices. It was found that generally, results compared favourably with other world-wide studies. No accidental pregnancies were experienced and no significant difference was found between the expulsion rate of the Nova-T (5.0) and that of the Copper-T-200 (6.5) and the removal rates for bleeding and pain, which were 1.5 and 3.8, respectively. The continuation rate for the Nova-T was 91.3 compared with 88.2 for the Copper-T. The total experience was based on 815 woman-months of use.
A total of 191 patients have undergone post-coital insertion of an intrauterine contraceptive device up to ten days post-coitus. The majority of patients were nulliparous and underwent insertion of a standard Gravigard [Copper 7] device. The subsequent expulsion and medical removal rates were normal for this group of patients but the non-medical removal rates were higher. There was one possible post-coital contraceptive failure (0.6%) and one pregnancy at six months due to the device exhibiting a failure to conventional contraceptive action.
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Comparative clinical trials of 2 sizes of contraceptive vaginal rings and of an oral contraceptive were undertaken at 8 investigational sites (9 clinics). More than 500 women enrolled on each of the 3 study regimens. Side effects of the rings and of Nordette, the oral contraceptive, were evaluated by noting spontaneous complaints, by recording medications taken and by physical examination. Inquiries about changes in the frequency of specific conditions were made at the end of the subjects participation in the first year of the study. The incidence of spontaneous complaints was similar among users of the 2 different-sized rings and of the pill.
In a long-term, prospective study the effects on lipoprotein lipids and apolipoproteins (apo) of a combined oral contraceptive (OC) (30 micro gram ethinylestradiol and 150 micro gram levonorgestrel) and a contraceptive vaginal ring (CVR) releasing estradiol (about 180 micro gram per day) and levonorgestrel (about 290 micro gram per day) were compared. The two treatments induced significantly different effects. In the OC group the lipoprotein-lipid concentrations showed only minor changes, but apolipoproteins (apo) B and A-I increased by about 15%. In contrast, during treatment with the CVR there was a 25% decrement of cholesterol in high density lipoprotein (HDL) and at most 10% in low density lipoprotein (LDL) cholesterol, with only minor effects on apo B and A-I. The ratio of LDL and HDL cholesterol increased in the CVR group but not in the OC group. The results also indicate a change in the composition of the LDL and HDL particles, with an altered lipid/protein ratio, during both contraceptive treatments. Despite the impressive relative increase in LDL:HDL ratio in the contraceptive ring group, the average absolute value of this ratio did not reach the mena for healthy men.