Abstract
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 17β-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 μg) 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.
Publication types
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Acne Vulgaris / drug therapy
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Adolescent
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Adult
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Androstenes / adverse effects
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Androstenes / therapeutic use
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Contraceptives, Oral, Combined / adverse effects*
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Contraceptives, Oral, Combined / therapeutic use*
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Contraceptives, Oral, Synthetic / adverse effects
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Contraceptives, Oral, Synthetic / therapeutic use
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Estradiol / adverse effects
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Estradiol / therapeutic use
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Estrogens / adverse effects
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Estrogens / therapeutic use
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Ethinyl Estradiol / adverse effects
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Ethinyl Estradiol / therapeutic use
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Female
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Humans
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Megestrol / adverse effects
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Megestrol / therapeutic use
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Menstrual Cycle / drug effects
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Metrorrhagia / chemically induced*
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Middle Aged
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Mineralocorticoid Receptor Antagonists / adverse effects
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Mineralocorticoid Receptor Antagonists / therapeutic use
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Norpregnadienes / adverse effects
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Norpregnadienes / therapeutic use
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Pregnancy
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Pregnancy Rate
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Substance Withdrawal Syndrome*
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Young Adult
Substances
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Androstenes
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Contraceptives, Oral, Combined
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Contraceptives, Oral, Synthetic
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Estrogens
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Mineralocorticoid Receptor Antagonists
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Norpregnadienes
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Ethinyl Estradiol
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Estradiol
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nomegestrol acetate
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Megestrol
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drospirenone