Pooled efficacy results of estetrol/drospirenone combined oral contraception phase 3 trials

Combined Oral Contraceptive Adherence and Pregnancy Rates

“…7,8 These differences are related to the population, including demographic characteristics and whether a participant had been using a hormonal contraceptive before enrollment. 9 Finding the best way to provide clinically meaningful data of pill effectiveness is a topic of considerable debate. Unlike past clinical trial reports that describe pregnancy rates for the study population (which is then population dependent), we evaluated pregnancy risk per cycle according to adherence.…”

“…7,8 The characteristics, protocols, and IRB approval information have been previously published, 7,8 as have the participant demographics from the pooled data used in this analysis. 9 Investigators conducted the trials in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki.…”

Estetrol: From Preclinical to Clinical Pharmacology and Advances in the Understanding of the Molecular Mechanism of Action

“…A pooled analysis of both phase III studies further demonstrated that E4/DRSP is an effective oral contraception overall, and, importantly, also across subgroups based on age, contraceptive history and body mass index [ 40 ]. The COC consisting of E4 15 mg/DRSP 3 mg is now approved and marketed in different territories, including Europe, Russia, US, Canada and Australia.…”

The benefits of estetrol addition to drospirenone for contraception

“…Two 13-cycle phase 3 trials with 15 mg E4 and 3 mg DRSP, one conducted in the United States and Canada (US/CAN) and one in Europe and Russia (EU/RUS), demonstrated a PI of 2.65 pregnancies per 100-women years in the US/CAN trial and 0.44 pregnancies per 100-women years in the EU/RUS trial ( Table 2 ). 62 A recent secondary analysis of the pooled E4-DRSP phase 3 studies further evaluated the 31 on-treatment pregnancies based simply on adherence to remove other confounders, including study location. 63 Pregnancies occurred in 0.09%, 0.25%, 0.83%, and 1.6% of cycles in which participants reported that they took all hormone pills (n=25,613 cycles) or omitted 1 (n=405 cycles), 2 (n=121 cycles), and more than 2 (n=314 cycles) hormone-containing pills ( P <.001).…”