Cyproterone acetate-ethinyl estradiol use in a 23-year-old woman with stroke.
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ABSTRACT:
SUBMITTER: Kromm J
PROVIDER: S-EPMC4049993 | biostudies-literature | 2014 Jun
REPOSITORIES: biostudies-literature
Publications
Cyproterone acetate-ethinyl estradiol use in a 23-year-old woman with stroke.
Kromm Julie J Jeerakathil Thomas T
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20140203 9
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Project description:ObjectivesTo evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily.Study designWe integrated clinical safety data from nine studies in which women used the CVS for 21 consecutive days and removed it for 7 days of each 28-day cycle. Four studies used the final manufactured CVS, including a 1-year pharmacokinetic study, two 1-year phase 3 trials and a second-year treatment extension study. We assessed safety by evaluating adverse events women reported in a daily diary. We also included data from focused safety studies evaluating endometrial biopsies, vaginal microbiology and liver proteins from one of the phase 3 studies.ResultsThe combined studies included 3052 women; 2308 women [mean age 26.7±5.1 years; mean body mass index (BMI) 24.1±3.7 kg/m2] received the final manufactured CVS, of whom 999 (43.3%) completed 13 cycles of use. Women using the final CVS most commonly reported adverse events of headache (n=601, 26%), nausea (n=420, 18%), vaginal discharge/vulvovaginal mycotic infection (n=242, 10%) and abdominal pain (n=225, 10%). Few (<1.5%) women discontinued for these complaints. Four (0.2%) women experienced venous thromboembolism (VTE), three of whom had risk factors for thrombosis [Factor V Leiden mutation (n=1); BMI>29 kg/m2 (n=2)]. During 21,482 treatment cycles in the phase 3 studies evaluable for expulsion, women reported partial expulsions in 4259 (19.5%) cycles and complete expulsions in 1509 (7%) cycles, most frequently in the initial cycle [499/2050 (24.3%) and 190/2050 (9.3%), respectively]. Safety-focused studies revealed no safety concerns.ConclusionThe 1-year SA/EE CVS has an acceptable safety profile. Additional studies are warranted in obese women at higher risk of VTE.ImplicationsThis 1-year contraceptive vaginal system represents a new long-term, user-controlled and procedure-free option with a safety profile similar to other combination hormonal contraceptives. The same precautions currently used for combination hormonal contraceptive prescriptions apply to this new contraceptive vaginal system.
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Project description:AimThe overdose of caffeine, a cytochrome P450 1A2 probe, in young women has become a problem. The aim of this study was to evaluate possible drug interactions between intentionally overdosed caffeine (12 g) and oral contraceptive doses of ethinyl estradiol prescribed to a young woman in a suicide attempt.MethodsThe serum concentrations of caffeine in the patient and the time-dependent ethinyl estradiol inhibition of caffeine oxidation in vitro were evaluated.ResultsThe serum concentration of caffeine 4 h after overdose was 136 μg/mL; from the data obtained between 4 and 28 h after overdose, the half-life was estimated to be 33 h, which is many times larger than the normal value. Prescribed ethinyl estradiol prolonged caffeine elimination in vivo and inhibited paraxanthine formation, as evidenced by the low serum concentrations. In human liver microsomes, ethinyl estradiol (50 nM) inhibited half of caffeine N 3 -demethylation. Pre-incubation of human liver microsomes with ethinyl estradiol resulted in a powerful time-dependent inhibitory effect on caffeine N 3 -demethylation in human liver microsomes.ConclusionThese results suggest that a prescription history of contraceptives at clinical doses may have a strong effect on the pharmacokinetics of overdosed caffeine in young women, resulting in dangerous drug interactions.
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Project description:The main goal of the study was to measure the epigenetic age (also known as DNA methylation age) of these tissues. Toward this end, we used the epigenetic clock software described in Horvath S (n=2013) DNA methylation age of human tissues and cell types. Genome Biology.2013, 14:R115. DOI: 10.1186/10.1186/gb-2013-14-10-r115 PMID: 24138928
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Project description:The main goal of the study was to measure the epigenetic age (also known as DNA methylation age) of these tissues. Toward this end, we used the epigenetic clock software described in Horvath S (n=2013) DNA methylation age of human tissues and cell types. Genome Biology.2013, 14:R115. DOI: 10.1186/10.1186/gb-2013-14-10-r115 PMID: 24138928 Human DNA methylation Beadchip v1.2 was used to obtain n=64 Illumina DNA methylation arrays from 30 tissues. For each of the following tissues, we obtained at least 2 replicates: adipose, adrenal gland, aorta, bone, bone-marrow, breast, buccal cells, cartilage, cerebellum, colon, diaphragm, esophagus , frontal cortex, kidney, heart, hippocampus, liver, lung, lymph node, midbrain, muscle, occipital cortex, pancreas, pericardium skin, spleen, stomach, temporal cortex, thyroid, whole blood.
2015-06-03 | E-GEOD-64491 | biostudies-arrayexpress