Contraception
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Randomized Controlled Trial Meta Analysis Comparative Study Clinical Trial
Another look at the Dalkon Shield: meta-analysis underscores its problems.
Numerous non-comparative clinical trials of the Dalkon Shield appear to provide ample evidence that the Dalkon Shield was an effective IUD; they seem to yield little evidence that it was a dangerous device, nor markedly different from its contemporaries. Equating the performance of the Dalkon Shield IUD to that of the Lippes Loop or of Copper IUDs is erroneous, however, with respect to rates of pregnancy, expulsion, pelvic infection, septic abortion, death with the device in situ, and tubal infertility. Randomized studies show the Dalkon Shield had approximately double the pregnancy rates of the Lippes Loop D or Copper IUDs (P < .05) and a significantly lower expulsion rate. ⋯ A five-fold increased risk of hospitalized pelvic infection among Dalkon Shield users found in the Women's Health Study resulted not from ascertainment bias, but was related to the fact that Dalkon Shield users had more severe hospitalized PID than did other hospitalized women with PID and IUD use. Following cessation of distribution and of use of the Dalkon Shield, and following the FDA's recommendation to remove IUDs in case of pregnancy, there have been no deaths reported among pregnant American women with an IUD in situ in a 15-year period. Neither the IUDs of today nor those in use during 1970-1974 are equitable to the Dalkon Shield [corrected].
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Randomized Controlled Trial Comparative Study Clinical Trial
A randomized comparative open study of the effects of two oral contraceptives, Triphasil and Ortho 7/7/7, on lipid metabolism.
This study assessed serum lipid, lipoprotein and apolipoprotein changes during one year in 3 groups of nonsmoking women: 1) Triphasil(R); 2) Ortho(R) 7/7/7; 3) Controls. Both oral contraceptives contain the estrogen, ethinyl estradiol(EE), in combination with a progestin in three different ratios during each cycle. The progestin in Triphasil is d-norgestrel, as the dl-racemate norgestrel (NG), whereas that in Ortho 7/7/7 is norethindrone(NE). ⋯ Apo B increased dramatically in the IDL fraction of both oral contraceptive user populations, with the range of increases being between 48% and 87% during the year (p < 0.001 at all times). Significant elevations in VLDL apo B ranged from 71% to 106% (p < 0.001) with Triphasil and from 42.4% (p < 0.005) to 72.6% (p < 0.001) with Ortho 7/7/7. In conclusion, norethindrone- and dl-norgestrel-formulations have divergent effects on several components of plasma lipoprotein and lipid metabolism, but both products increase plasma and IDL apo B.
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Randomized Controlled Trial Comparative Study Clinical Trial
Termination of second trimester pregnancy with sulprostone and mifepristone: a randomized double-blind placebo-controlled trial.
A prospective randomized double-blind placebo-controlled trial was conducted in 13 subjects to find out whether mifepristone treatment could facilitate termination of second trimester pregnancy by sulprostone. The women received either 600 mg oral mifepristone or placebo tablets 36 hours before the administration of intramuscular sulprostone 0.5 mg every 6 hours. ⋯ There was no significant difference in the incidence of side effects or analgesic requirement between the two groups. We conclude that oral mifepristone is useful in facilitating termination of second trimester pregnancies by sulprostone.
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Randomized Controlled Trial Comparative Study Clinical Trial
Pharmacokinetics of levonorgestrel and ethinylestradiol in 9 women who received a low-dose oral contraceptive over a treatment period of 3 months and, after a wash-out phase, a single oral administration of the same contraceptive formulation.
The pharmacokinetics of levonorgestrel (LNG) and ethinylestradiol (EE2) were determined in 9 healthy women (age 23 to 42 years), during a treatment period of three months with a low-dose oral contraceptive, containing 0.15 mg LNG together with 0.03 mg EE2 (Microgynon). After a wash-out period of 3 months, 8 of these women received a single administration of the same formulation. The results showed that there was an increase in serum trough levels of LNG, reaching steady-state in the second half of each treatment cycle. ⋯ An about 50% reduction in total and unbound clearance of LNG was observed during chronic treatment, as compared to single dose administration. Increased SHBG binding capacity and a reduced hepatic metabolic capacity were discussed as possible causes of accumulating LNG concentrations in the serum. On the last day of treatment cycles one and three, the AUC(0-24h) values of EE2 were 728 +/- 314 and 778 +/- 318 pg x ml-1 x h, respectively, and were in keeping with data reported from others.
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Fifty nine women with documented normal ovulatory cycles and with no symptoms of vaginal infection were divided into four groups. Each group used a combined contraceptive vaginal ring (CCVR) with a mean daily release rate of 0.015 mg of ethinyloestradiol (EE) and 0.120 mg of 3-ketodesogestrel (3-KDG) per day, for one cycle of either 21, 28, 42, or 56 days. Cultures from the posterior vaginal fornix and from the endocervical canal were obtained immediately before insertion of the ring and on removal of the ring. ⋯ Intra- and inter- group changes in the vaginal flora were assessed at the end of each treatment. The comparison between the number and type of flora showed no significant change between the pre-treatment population and the post-treatment population. The results of this study suggest that the use of this CCVR for 21, 28, 42 and 56 days is not associated with an increase in inflammatory cells or pathogenic bacteria.