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PiluleĀ® (ethinyl estradiol vaginal tablet)
PiluleĀ® (ethinyl estradiol vaginal tablet) is a levonorgestrel/ethinyl estradiol vaginal tablet that is available with five doses per pack (2 tablets) containing 50 mcg ethinyl estradiol/0.25 mg estradiol.
PiluleĀ® is indicated for use in postmenopausal women who are at least 15 years old. There are no age restrictions for the use of this contraceptive.
PiluleĀ® may be used as a single continuous (continuous) oral contraceptive for up to 5 years after start of use.
The effect of age on safety, efficacy and contraceptive effectiveness of PiluleĀ® in women reproductive potential, including adolescents and women aged 19 to 45 years, was evaluated in a clinical and postmarketing study. The primary end point was to examine the risk of serious adverse events in patients who were age 35 years and older. The secondary tertiary end points included the following: safety, efficacy, and effect of age on the effectiveness PiluleĀ®, and all-cause pregnancy rate after 3, 6, and 12 months of use.
Safety:
In this study, there were no serious adverse events (ie, Zyban kaufen ohne rezept death, sepsis, stroke, blood can you buy prednisolone online clots, or gastrointestinal bleeding), and no cases of aplastic anemia and endometrial hyperplasia. No severe adverse events were reported (eg, headache, nausea, vomiting, fever).
Efficacy:
PiluleĀ® was effective in preventing pregnancy and increasing the total rate from 4.3 to 8.5%, and in increasing the rate of live births from 0.5 to 1.6%. The pregnancy rate was similar in all age groups (3 to 16 years: 8.7%; 25 8.4%; 26 to 34 years: 8.9%; 35 44 8.5%; and 45 to 54 years: 8.4%). Although the risk of severe adverse events, including venous thromboembolism, thromboembolic disease, and events, was increased, there no increase in serious adverse events (ie, death, sepsis, stroke, blood clots, or gastrointestinal bleeding) with the use of PiluleĀ® in any the age groups.
Effect of age on efficacy and safety:
In this study, the rate of serious adverse events (ie, venous thromboembolism, thromboembolic disease, and events) was approximately twofold greater in women aged ā„35 years compared with women aged 15 to 19 years (risk ratio [RR] = 2.52; 95% confidence interval [CI] = 1.23-4.13; P <.001). There was a trend toward increased risk of thromboembolic disease (RR = 2.13; Prednisolone 10mg $130.36 - $0.36 Per pill 95% CI 1.02-4.21). There was no trend toward increased risk of thromboembolic events in women aged ā„35 years compared with women aged 15 to 19 years (RR = 1.22; 95% CI 0.85-1.81; P =.16), but increased risk of thromboembolic disease was observed in women aged ā„35 years compared with women aged 15 to 19 years (RR = 3.06; 95% CI 1.23-9.17; P <.001).
Pilot clinical study of PiluleĀ® in postmenopausal women.
Pilot clinical study of PiluleĀ®
Study Design: of postmenopausal women using PiluleĀ®
Study population: A total of 16 premenopausal women, aged 18 to 45 years, at increased risk of thromboembolic disease and venous thromboembolism or who had received prior use of estrogen replacement therapy (ERT) (eg, hormone [HRT] or tamoxifen) whose pregnancy has been terminated by ERT and who were not using a hormonal contraceptive.
Outcomes: Clinical efficacy and safety outcomes, including adverse events, were evaluated.
Interventions: For the PiluleĀ® study, women were assigned to receive PiluleĀ® (50 mcg ethinyl estradiol vaginal tablet) or placebo every 3 months for the first 6 months; thereafter, women were randomized to receive PiluleĀ® for 12 cycles at 3-month intervals followed by a 1:1 open-label extension with PiluleĀ® for another 12 cycles at 3-month intervals, buy prednisolone in uk or continue with the placebo. There was no loss to follow-up or allocation concealment.
Primary end point: Number of pregnancies and pregnancy rate.
Secondary end point: Number of pregnancies,.
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