A 12-month evaluation of the CMA-containing oral contraceptive Belara: efficacy, tolerability and anti-androgenic properties.
OBJECTIVE
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.
Schramm
Georg
G
Medical Department, Grünenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany. Georg.Schramm@grunenthal.de
Steffens
Doris
D
D000328:Adult; D000568:Amenorrhea / Q000209:etiology; D000726:Androgen Antagonists / Q000008:administration & dosage*; D002715:Chlormadinone Acetate / Q000008:administration & dosage*; D003267:Contraception; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage*; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D045167:Progesterone Congeners / Q000008:administration & dosage*; D014592:Uterine Hemorrhage / Q000209:etiology
D000726:Androgen Antagonists; C112985:Belara; D003280:Contraceptives, Oral, Synthetic; D045167:Progesterone Congeners; D002715:Chlormadinone Acetate; D004997:Ethinyl Estradiol