OBJECTIVES: The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17beta-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE). METHODS: Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=1591) or DRSP/EE (3 mg/30 mug) in a 21/7-day regimen (n=535) for 13 cycles. RESULTS: Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged</=35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs. CONCLUSIONS: These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.
Schöll, M., Vogel, J. W., Schonhaut, D., Lockhart, S., Baker, S., Schwimmer, H., … Jagust, W. J. (2015). O5-01-04: Cognitive decline in healthy elderly is related to temporal lobe tau but not to cortical β-amyloid: An 18F-AV1451 and 11C-PiB PET study. Alzheimer’s & Dementia, 11(7S_Part_7), P313–P314. https://doi.org/10.1016/j.jalz.2015.07.448