Bleeding Pattern and Management of Unexpected Bleeding/Spotting with an Extended Regimen of a Combination of Ethinylestradiol 20 mcg and Drospirenone 3 mg.

OBJECTIVE: To compare the bleeding pattern in women using ethinylestradiol 20 mcg/drospirenone 3 mg (EE 20 mcg/DRSP 3 mg) in a 24/4-day cyclic regimen with an extended regimen. Unexpected bleeding/spotting in the extended regimen group was managed by allowing a 4-day hormone-free interval (HFI). METHODS: This was a randomized, prospective, open-label, multicenter study. Participants (N = 348) were randomized to receive EE 20 mcg/DRSP 3 mg in either an extended regimen (EE/DRSPes group) or a 24/4-day cyclic regimen (EE/DRSP24/4 group) and followed for 168 days. In the EE/DRSPes group, a 4-day HFI was allowed whenever unexpected bleeding/spotting persisted for ≥7 consecutive days. The participants assessed their bleeding daily as "no bleeding," "spotting," or "light," "moderate," or "heavy" bleeding according to a predefined scale. RESULTS: EE/DRSPes group experienced fewer days of bleeding than those using a 24/4 cyclic regimen (P < 0.001). After 168 days, 57.5% of women in the EE/DRSPes group achieved complete amenorrhea (i.e., neither bleeding nor spotting) and 73.9% achieved "no bleeding" (i.e., no bleeding with or without spotting) during the final 28-day interval of the study period. Women in the extended group who instituted the 4-day HFI experienced a 94.1% rate of successful management of unexpected bleeding/spotting. CONCLUSION: The use of EE 20 mcg/DRSP 3 mg in an extended regimen resulted in high rates of amenorrhea and "no bleeding". Unexpected bleeding/spotting in the EE/DRSPes group could be managed effectively with a 4-day HFI. CLINICAL TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN57661673): http://www.controlled-trials.com/isrctn/pf/57661673.

Contraception for women with heart disease: an update.

BACKGROUND: It is estimated that by the year 2013, 303.000 women worldwide died as a result of pregnancy-related conditions. The risk of pregnancy complications in women with heart disease depends on the specific disease and on the individual conditions of each patient. EVIDENCE ACQUISITION: A bibliographic research was carried out on PubMed using the descriptors "heart disease" AND "contraceptive" OR "pregnancy" AND "thrombosis" OR "angina" OR "cardiopathy". A total of 1456 articles were found. EVIDENCE SYNTHESIS: Classification of heart disease in pregnancy according to the severity of the condition include high, intermediate or low-risk cardiac patients. Tubal ligation is indicated for women with high-risk heart disease. Reversible methods are possible for intermediate or low-risk cardiac patient, but formal contraindications for estrogens are present in large percentage of clinical conditions and progestogen-only formulations are generally considered. Contraindications to the use of an intrauterine device disease should be considered. CONCLUSIONS: According to the different forms of heart disease, different contraceptive methods are recommended.

Transvaginal ultrasonography and hysteroscopy as predictors of endometrial polyps in postmenopause.

The study compared ultrasound and ambulatorial hysteroscopy as diagnostic methods detecting endometrial polyps in postmenopause women. 281 women aged 41-82 years who underwent ambulatorial hysteroscopy were analyzed for presence of uterine bleeding and/or altered transvaginal ultrasound (endometrial thickness ≥5 mm). Ultrasonography detected endometrial polyps in 22.8% of patients and endometrial thickening in the other 59.8%. Hysteroscopy diagnosed endometrial polyps in 80.8%. Ultrasonography showed sensitivity of 88.7%, specificity of 25.4%, positive predictive value of 81.7%, negative predictive value of 37.5% and accuracy of 75.4% in diagnosing endometrial polyps. Hysteroscopy showed 96.4% sensitivity, 74.6% specificity, 93.4% positive predictive value, 84.6% negative predictive value and 91.8% accuracy. Hysteroscopy demonstrated more accuracy than ultrasonography, which is not sufficient for accurate diagnosis.

Effects of estrogen and estrogen-progestogen therapy on homocysteine levels and their correlation with carotid vascular resistance.

OBJECTIVE: To evaluate the correlation between homocysteine levels and carotid vascular resistance in menopausal women submitted to estrogen and estrogen-progestogen therapy. METHODS: Eighty-six women with a mean age of 52 years were enrolled in a prospective, randomized, double-blind, 6-month study. Patients were allocated to use one of three oral therapies: placebo (n = 26), micronized estradiol 2 mg/day (n = 30) or micronized estradiol 2 mg/day plus norethisterone acetate 1 mg/day (n = 30). Evaluation of homocysteine levels and Doppler sonography of the common carotid artery, used to calculate pulsatility index (PI), were carried out prior to initiating therapy and at the end of the study. The correlation between these two parameters was evaluated using Pearson's coefficient of correlation. RESULTS: There was a significant reduction in homocysteine levels in the groups treated with estrogen alone or estrogen combined with norethisterone. PI was significantly lower only in users of estrogen alone; however, no significant correlation was found between homocysteine measurements and PI. CONCLUSION: No significant correlation was found between homocysteine levels and carotid vascular resistance following hormone therapy.