Contraceptive Efficacy and Tolerability of Chlormadinone Acetate 2mg/ Ethinylestradiol 0.03mg (Belara??)*

Contraceptive efficacy and safety of a low-dose oral contraceptive, (0.03 mg ethinyl oestradiol and 2 mg chlormadinone acetate) Belara®, over three medication cycles

“…The results of this trial compare favourably with those of trials of other OCs, during which much higher residual ovarian activity (up to 50%) has been reported 3,10 . Our data also compare favourably with those of previous reports on the efficacy and safety of EE/CMA [17][18][19] and post-marketing surveillance trials 20 . For example, in a multicentre, phase III trial during which 1655 women took EE/CMA for a total of 22337 cycles, contraceptive efficacy was outstanding (adjusted Pearl index of 0.27) and it was associated with great cycle stability, and beneficial anti-androgenic effects on both hair and skin 19 .…”

Ethinylestradiol/Chlormadinone Acetate

“…The most commonly reported adverse events in two post-marketing trials investigating EE CMA in large patient populations (n = 21 820 and 2620) were breast pain and headache migraine (figure 3). [25,26] A small effect of EE CMA on average body weight was observed in those studies, with an increase of 0.9-1.1% observed with EE CMA administration. [25,26] It is well known that oral contraceptives are associated with a small increased risk of cardiovascular events.…”

“…EE CMA 0.03 mg 2 mg is a combined monophasic contraceptive pill with anti-androgenic properties. [24][25][26][27] EE CMA con-tains the estrogen, ethinylestradiol and the progestin chlormadinone acetate. It is approved in Europe for contraception [28] (Balianca, Belara) where it has also undergone testing in phase III clinical trials for the treatment of acne; [24,29] the combination therapy is not approved for use in the USA.…”

“…[29] Data from uncontrolled clinical trials investigating the contraceptive efficacy of EE CMA in women that support the possible effect of EE CMA in patients with seborrhea are presented in table I. [25,26,34,37,38,40] Taken together, these limited data suggest that EE CMA may be effective for the management of seborrhea; however, further examination of EE CMA in seborrhea is required.…”

Suppression of ovarian function by a combined oral contraceptive containing 0.02 mg ethinyl estradiol and 2 mg chlormadinone acetate given in a 24/4-day intake regimen over three cycles

“…A number of publications have reported the contraceptive efficacy and safety of this formulation, as well as its antiandrogenic benefit (13)(14)(15)(16)(17)(18). In a phase II trial, the contraceptive and pharmacologic mechanisms were investigated with use of the modified Hoogland and Skouby scale, and the ovarian activity was found to be suppressed effectively (5).…”