Contraception
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The objective of this study was to evaluate women's acceptance of and ability to self-administrate the injectable contraceptive Cyclofem using prefilled UniJect devices. A total of 102 women were invited to participate in the study. Fourteen women (13.7%) refused to participate. ⋯ The evaluation of the self-administered injection technique showed that more than 90% of the women correctly self-administered the contraceptive using UniJect. With respect to the opinion of the women about the self-administration of the contraceptive, more than 50% (32 of 56) of women who self-injected preferred to self-administer the injection and said that they wished to continue with the self-administration, one-third (17) reported that they were afraid, and seven women (12.5%) expressed the opinion that the injection in the thigh was more painful than the administration in the buttocks or arm. In conclusion, our study showed that women can be trained to successfully self-administer the monthly injectable contraceptive Cyclofem and generally respond positively to UniJect.
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Comparative Study Clinical Trial
Phase II clinical trial of a vas deferens injectable contraceptive for the male.
Following up on an earlier clinical trial demonstrating the safety of an intra-vas deferens injection of a contraceptive drug named Risug, comprised of styrene maleic anhydride (SMA) in a solvent vehicle of dimethylsulphoxide (DMSO), a study to assess the contraceptive effectiveness of a specific dose (60 mg) of SMA bilaterally was planned and implemented. Male subjects and their wives with normal reproductive profiles were the volunteer subjects. The wives were not using any contraceptives. The results reconfirm the safety and show that for a period of at least 1 year, the treatment leads to azoospermia in the male and gives pregnancy protection.
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The objective of this study was to assess the risk of myocardial infarction (MI) associated with the use of new and old combination oral contraceptives (OC). A matched case-control study in 16 centers in Germany, the United Kingdom, France, Austria, and Switzerland explored the association of current use of combination OC with the occurrence of MI. Our subjects were 182 women aged 16-44 years with MI; the controls were 635 women without MI (at least one hospital control and one community control per case) matched for 5-year age group and region. ⋯ A significantly lower risk of MI is found when comparing use of third generation OC with use of second generation OC. There seems to be an impressive amelioration of risk among smokers using newer OC. An impact of regulatory action in the UK was found in the OC use spectrum of controls.
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Multicenter Study
First-time use of newer oral contraceptives and the risk of venous thromboembolism.
Recent epidemiologic studies reported that the risk of venous thromboembolism (VTE) was higher with the use of the newer third generation oral contraceptives than with second generation agents. Although the overall findings of these studies are similar, the results, as they relate to patterns and duration of oral contraceptive use particularly among first-time users, are inconsistent. We reanalyzed data from the Transnational case-control study to assess the risk of VTE associated with first-time use of oral contraceptives as a function of its duration of use. ⋯ We found, for first-time users, that the adjusted rate ratio of VTE as a function of the duration of oral contraceptive use is essentially identical for second and third generation pills relative to never users. This rate ratio increases to around 10 in the first year of use and decreases to around two after 2 years of use, remaining at this risk level thereafter for both second and third generation agents. We conclude that second and third generation agents are associated with identical risks of venous thromboembolism when they are prescribed to women who are using oral contraceptives for the first time ever.
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Nonsteroidal anti-inflammatory drugs are frequently avoided by some investigators in protocols for medical abortion because of a concern over potential inhibition of prostaglandin action on uterine contractions. To evaluate the effects of nonsteroidal anti-inflammatory drugs on uterine cramping and resultant pregnancy expulsion, analgesic use by 449 participants with gestational age of < or = 56 days in three previously reported medical abortion trials involving methotrexate and misoprostol was reviewed. Subjects from each of the three trials were included in this analysis only if they received 50 mg/m2 methotrexate intramuscularly followed 3 or 7 days later by 800 micrograms misoprostol vaginally. ⋯ Similarly, 27/56 (48.2%) of the women who took a nonsteroidal anti-inflammatory drug aborted within 24 h of the second dose of misoprostol. However, only 32/145 (22.1%, p = 0.002) of the women who did not take a nonsteroidal anti-inflammatory drug aborted. Use of a nonsteroidal anti-inflammatory drug does not interfere with the action of misoprostol to induce uterine contractions and pregnancy expulsion in women receiving methotrexate and misoprostol for early abortion.