ABSTRACT
BACKGROUND: This trial was conducted to compare cycle control with vaginal ring a combined contraceptive vaginal ring, and a combined oral contraceptive (COC) delivering 30 mug ethinylestradiol (EE) and 150 mug levonorgestrel. METHODS: This open-label, randomized, multi-centre, Phase III study involved adult women from 11 countries. Subjects were treated with either vaginal ring or a COC for 13 cycles (12 months). RESULTS: A total of 1030 subjects (vaginal ring, n=512; COC, n=518) comprised the intention-to-treat (ITT) population. The percentage of women in the ITT population who completed the trial was 70.9% for vaginal ring and 71.2% for the COC group. The incidence of breakthrough bleeding and spotting over cycles 2-13, the primary efficacy parameter, was lower with vaginal ring (range 2.0-6.4%) than the COC (range 3.5-12.6%), and for cycles 2 and 9 the lower incidence with vaginal ring was confirmed as statistically significant (P=0.003 and P=0.002 respectively). The incidence of intended bleeding was significantly higher over all cycles with vaginal ring (58.8-72.8%) than with the COC (43.4-57.9%). CONCLUSIONS: Cycle control with vaginal ring was excellent and superior to that of a COC containing 30 mug EE.
Subject(s)
Contraceptive Devices, Female , Contraceptives, Oral, Synthetic/administration & dosage , Estrogens/administration & dosage , Ethinyl Estradiol/administration & dosage , Levonorgestrel/administration & dosage , Adult , Contraceptive Devices, Female/adverse effects , Contraceptives, Oral, Synthetic/adverse effects , Estrogens/adverse effects , Ethinyl Estradiol/adverse effects , Female , Humans , Incidence , Levonorgestrel/adverse effects , Menstrual Cycle/drug effects , Patient Compliance , Pregnancy , Pregnancy Rate , Uterine Hemorrhage/epidemiologyABSTRACT
Two uncommon cases of bilateral breast ischaemia in men are reported. Only one similar case has been published so far. Women, after pregnancy and delivery may also have fat necrosis of the breast, but it is also very unusual. Clinical symptoms are serious, and like tumours. The histological diagnosis is difficult to distinguishable from tissue changes due to self injected paraffin. However in those cases the X ray clearly shows pathognomonic signs of a paraffinoma. The physiopathology is still unclear. In our two cases we did not find any specific etiology. The main contributing factors are likely to be gynaecomastia and adipomastia complicated by lipo-glandular lysis caused by deep glandular ischemia.
