OBJECTIVES AND METHODS: A postmarketing survey was carried out to determine the efficacy and tolerability of Valette (dienogest 2.0 mg and ethinylestradiol 0.03 mg) in routine gynecological practice. RESULTS: Valette had excellent contraceptive efficacy (unadjusted Pearl index 0.14), with 11 unplanned pregnancies from a total of 92 146 cycles of exposure, of which at least four were attributable to user failure. Cycle control was good, with spotting and breakthrough bleeding, which affected 5.0% and 3.4% of women, respectively, during the first cycle, becoming less frequent thereafter. Silent menstruation, i.e. the absence of withdrawal bleeding, affected on average 2.0% of women per cycle and 5.9% within the observation period. Valette was well tolerated. The most common adverse drug reactions were mastalgia (1.46% of all users), weight gain (1.11%), headache (0.98%), nausea/vomiting (0.96%), dysmenorrhea (0.35%), decreased libido (0.31%) and depressive moods (0.28%). The dropout rate due to adverse drug reactions was only 3.2%. Only six of the 16 267 women reported events which were considered to be serious adverse drug reactions; all recovered with appropriate treatment. CONCLUSIONS: These results confirm those from previous clinical trials, and demonstrate that Valette is highly effective, very well tolerated and produces excellent cycle control in routine practice.
OBJECTIVES AND METHODS: A postmarketing survey was carried out to determine the efficacy and tolerability of Valette (dienogest 2.0 mg and ethinylestradiol 0.03 mg) in routine gynecological practice. RESULTS: Valette had excellent contraceptive efficacy (unadjusted Pearl index 0.14), with 11 unplanned pregnancies from a total of 92 146 cycles of exposure, of which at least four were attributable to user failure. Cycle control was good, with spotting and breakthrough bleeding, which affected 5.0% and 3.4% of women, respectively, during the first cycle, becoming less frequent thereafter. Silent menstruation, i.e. the absence of withdrawal bleeding, affected on average 2.0% of women per cycle and 5.9% within the observation period. Valette was well tolerated. The most common adverse drug reactions were mastalgia (1.46% of all users), weight gain (1.11%), headache (0.98%), nausea/vomiting (0.96%), dysmenorrhea (0.35%), decreased libido (0.31%) and depressive moods (0.28%). The dropout rate due to adverse drug reactions was only 3.2%. Only six of the 16 267 women reported events which were considered to be serious adverse drug reactions; all recovered with appropriate treatment. CONCLUSIONS: These results confirm those from previous clinical trials, and demonstrate that Valette is highly effective, very well tolerated and produces excellent cycle control in routine practice.
Authors: Maurizio Guida; Giuseppe Bifulco; Attilio Di Spiezio Sardo; Mariamaddalena Scala; Loredana Maria Sosa Fernandez; Carmine Nappi Journal: Int J Womens Health Date: 2010-08-24