A new estrogen-free pill containing
only drospirenone led to significant improvement in bleeding patterns and
tolerability, with a decline in discontinuation rates.
Compared to desogestrel, females using drospirenone-only oral contraceptive experience an improvement in quality of life, acceptability, bleeding, and compliance to the contraceptive method. Also, lower discontinuation rates were reported in females using drospirenone pills, as elucidated from a phase III study published in Gynecological Endocrinology.
Investigators undertook this double-blind, double-dummy, prospective study to explore the impact of estrogen-free drospirenone-only pill 4 mg vs. desogestrel 0.075 mg on discontinuation rates due to adverse events and unacceptable bleeding disorders. The study recruited healthy females (age 18-45 years) assessing 858 females with 6691 drospirenone and 332 females with 2487 desogestrel therapy cycles.
Compared to the desogestrel arm, a greater percentage of females in the drospirenone arm reported treatment-emergent adverse events (TEAEs) resulting in premature study termination.
In total, 9.6% (82/858) of women in the drospirenone group and 13.3% (44/332) of women in the desogestrel group experienced treatment-emergent adverse events (TEAEs) resulting in premature termination of the study (Table 1). This implies that 32% more females in the drospirenone group completed the trial when compared to the desogestrel group (on the basis of area under curve [AUC] of Kaplan-Meier's curves). Compared to the desogestrel group, the drospirenone group showed a 55% reduced discontinuation rate due to abnormal bleeding, as shown in Table 1:
Thus, the improvement in acceptability of the bleeding profile of the novel progestin-only pills with drospirenone alone will aid to boost the use of progestin-only pills in all groups of females.
Gynecological Endocrinology
Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel
Pedro-Antonio Regidor et al.
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