A multicenter, double-blind, randomized trial on the bleeding profile of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg

Abstract

Purpose A typical compliance problem in the use of traditional progestin-only pills is the irregular bleeding pattern and the strict daily intake. Desogestrel 75 mg has a 12-h missed-pill window; however, its poor cycle control limits a more common use. Methods A drospirenone (DRSP)-only pill was developed to improve the bleeding profile. Setting A phase III study in healthy women aged 18–45 years was performed to compare the bleeding profile and safety of a DRSP-only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over nine cycles. Population A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed. Main outcome measures The primary end point was the proportion of women with unscheduled bleeding/spotting in each cycle from cycles 2 to 9 and cumulative in cycles 2–4 and cycles 7–9. Results In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test). Conclusions This report describes the improvement in bleeding profile of women using the new DRSP-only oral contraceptive in comparison to DSG, providing a better quality of live and adherence to the contraceptive method. EudraCT Registration Number: 2011-002396-42.

Oral Progestins in Hormonal Contraception: Importance and Future Perspectives of a New Progestin Only-Pill Containing 4 mg Drospirenone

“…Bleeding pattern: control of bleeding profile with 4 mg DRSP in comparison to 75 µg desogestrel. A phase III clinical trial over 9 administration cycles compared bleeding profiles of women treated with 4 mg DRSP and women treated with 75 µg desogestrel [46,47]. The percentage of women with bleeding and spotting decreased in the 4 mg DRSP group from 69.2 % in administration cycle 2 to 56.3 % in administration cycle 9, and in the 75 µg desogestrel group from 74.05 % to 45.3 %.…”

Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

“…Moreover, the rate of patients with prolonged bleeding (>10 days) was significantly lower in the 4 mg drospirenone group compared with the 75 lg desogestrel group for cycles 5-9 (p < 0.001). Early study withdrawal related to abnormal uterine bleeding (AUB) was reported for 3.3% of participants who received 4 mg drospirenone against 6.6% who took 75 lg desogestrel (p < 0.001) [27]. The results demonstrated that cycle control with 4 mg drospirenone was superior to that with 75 lg desogestrel.…”

“…A comparison of cycle control between 4 mg drospirenone and 75 lg desogestrel was performed in a study of nine cycles [27]. The proportion of women with bleeding and spotting decreased from 69.7% in cycle 2 to 56.3% in cycle 9 in the 4 mg drospirenone group and from 74.0% to 45.3% in the 75 lg desogestrel group; the overall median number of bleeding and spotting days decreased from 10 days (first reference period: cycles 2-4) to 6 days (last reference period: cycles 7-9) in the 4 mg drospirenone group and from 12 to 7 days in the 75 lg desogestrel group.…”

The Progestin Revolution: progestins are arising as the dominant players in the tight interlink between contraceptives and bleeding control

“…The most recent novel introduction of a high dose progestin only pill is the 4 mg drosperinone oral contraceptive pill that provides a progestin-only option with good bleeding control. This pill also allows a non-time-restricted daily intake, very different from low-dose POP options [ 4 ].…”

“…The 4 pill free days are designed allow a controlled withdrawal bleeding episode [compared to the 28-day minipill regimen with no window for bleeding]. This high dose drosperinone oral contraceptive pill provides a progestin-only option with good bleeding control without the restricted daily intake 2–3 h time frame [ 4 ].…”