The aim of this open, noncontrolled phase III study was the assessment of the
contraceptive efficacy and the evaluation of the safety of long-term use of
Belara (30 micrograms
ethinyl estradiol plus 2 mg
chlormadinone acetate). Furthermore, cycle stability during administration of
Belara and the influence of
Belara on
acne and
seborrhea as clinical signs of
androgenization were observed.
Belara was taken by 1655 women for a total of 22,337 cycles. For the theoretical Pearl index, a value of 0.269 (95% CI [0.109, 0.600]) was calculated. In 1655 of 22,337 cycles (7.4%), no withdrawal
bleeding was documented, whereas in 2565 of 22,308 cycles (11.5%), spottings and, in 786 of 22,308 cycles (3.5%),
breakthrough bleeding occurred. After the intake of
Belara for 12 cycles,
acne on the face/neck improved in 64.1% of the women (209 of 326). In 53.4% of the women (175 of 326),
acne disappeared completely.
Seborrhea improved after 12 cycles in 89 of 131 women (67.9%), of whom 76 women (58.0%) were completely cured. Sixty-two serious adverse events (SAE) occurred in 59 of 1655 women. Accidents and
injuries of the musculoskeletal system were the SAE with the highest incidence (0.66%). Two cases of
deep venous thrombosis, one
pulmonary embolism, and two cases of visual disturbances were observed. Only for the two cases of
deep venous thrombosis could a relation to
Belara be assumed. Of the adverse events commonly reported for
oral contraceptives,
headache was observed for the first time under study medication in 37.4%,
nausea in 23.1%, breast tenderness in 21.7%, and
vaginal discharge in 19.4% of the women. The frequency of adverse events decreased with longer duration of a
drug consisting of intake of
Belara. In conclusion,
Belara can be described as an effective and safe
oral contraceptive with marked antiandrogenic properties.