Georg Schramm1, Doris Steffens. 1. Medical Department, Grünenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany. Georg.Schramm@grunenthal.de
Abstract
OBJECTIVES: We conducted a postmarketing surveillance study to assess the long-term efficacy and tolerability of the oral contraceptive Belara (chlormadinone acetate 2.0 mg/ethinylestradiol 0.03 mg) in a normal outpatient setting. Another interest focused on changes in androgen-related skin and hair disorders. METHODS: A total of 2620 women were enrolled in a 12-cycle clinical evaluation at 435 gynecological practices throughout Germany. RESULTS: An unadjusted Pearl index of 0.44 was calculated. At least 9 out of 10 pregnancies were attributable to user failure, thus resulting in an adjusted Pearl index of 0.04. More than two thirds (67.3%) of the women did not experience any bleeding disorder. Patients with intermenstrual bleeding or amenorrhea at study entry reported complete relief in 61.7% and 89.3%, respectively. Women who previously suffered from spots or bad skin showed significant improvement during the observation period (85.6%). Likewise, the percentage of patients with greasy or very greasy hair decreased markedly. The vast majority of women scored the tolerability of Belara as "very good" or "good." CONCLUSIONS: The results of this postmarketing study confirm that Belara is well tolerated and provides a high contraceptive efficacy, reliable cycle stability and beneficial effects on skin and hair.
OBJECTIVES: We conducted a postmarketing surveillance study to assess the long-term efficacy and tolerability of the oral contraceptive Belara (chlormadinone acetate 2.0 mg/ethinylestradiol 0.03 mg) in a normal outpatient setting. Another interest focused on changes in androgen-related skin and hair disorders. METHODS: A total of 2620 women were enrolled in a 12-cycle clinical evaluation at 435 gynecological practices throughout Germany. RESULTS: An unadjusted Pearl index of 0.44 was calculated. At least 9 out of 10 pregnancies were attributable to user failure, thus resulting in an adjusted Pearl index of 0.04. More than two thirds (67.3%) of the women did not experience any bleeding disorder. Patients with intermenstrual bleeding or amenorrhea at study entry reported complete relief in 61.7% and 89.3%, respectively. Women who previously suffered from spots or bad skin showed significant improvement during the observation period (85.6%). Likewise, the percentage of patients with greasy or very greasy hair decreased markedly. The vast majority of women scored the tolerability of Belara as "very good" or "good." CONCLUSIONS: The results of this postmarketing study confirm that Belara is well tolerated and provides a high contraceptive efficacy, reliable cycle stability and beneficial effects on skin and hair.