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A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen.


ABSTRACT: Objectives:To evaluate contraceptive effectiveness and safety of oral drospirenone 4?mg 24/4-day regimen in the United States. Study design:We performed a prospective, single-arm, multicenter phase 3 trial in sexually active women for up to thirteen 28-day treatment cycles. Primary outcome was the Pearl index, calculated using confirmed on-drug pregnancies and evaluable cycles in nonbreastfeeding women aged ? 35?years. We assessed adverse events (AEs), including hyperkalemia and venous thromboembolism. Results:Of 1006 women who received at least one dose of drospirenone, 352 women (35.0%) completed the trial and 654 (65.0%) women discontinued before trial end. Most participants (92.2%) were?? 35?years; one third had a body mass index (BMI) ? 30?kg/m2. Among nonbreastfeeding women aged ? 35?years, there were 17 pregnancies (Pearl index: 4.0; 95% confidence interval [CI], 2.3-6.4; n?=?953), of which three were unconfirmed and two were from sites excluded from the main analysis for major breaches of Food and Drug Administration regulations. The Pearl index was 2.9 (95% CI: 1.5-5.1) for confirmed pregnancies among 915 nonbreastfeeding women aged ? 35?years from sites with no protocol violations. Nearly all (95.4%) treatment-emergent AEs were mild or moderate in intensity. No cases of venous thromboembolism were reported. The frequency of hyperkalemia was 0.5%. Women with baseline systolic/diastolic blood pressure???130/85?mmHg had a mean reduction from baseline in blood pressure at exit visit (- 8.5/- 4.9?mmHg; n?=?119). No other clinically relevant changes were observed. Participant satisfaction was high. Conclusion:Drospirenone 4?mg 24/4 regimen provides effective contraception with a good safety/tolerability profile in a broad group of women, including overweight or obese women. Implications:This new progestin-only contraceptive, drospirenone 4?mg in a 24/4 regimen, provides a contraceptive option for the majority of women regardless of blood pressure or BMI.

SUBMITTER: Kimble T 

PROVIDER: S-EPMC7286157 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen.

Kimble Thomas T   Burke Anne E AE   Barnhart Kurt T KT   Archer David F DF   Colli Enrico E   Westhoff Carolyn L CL  

Contraception: X 20200130


<h4>Objectives</h4>To evaluate contraceptive effectiveness and safety of oral drospirenone 4 mg 24/4-day regimen in the United States.<h4>Study design</h4>We performed a prospective, single-arm, multicenter phase 3 trial in sexually active women for up to thirteen 28-day treatment cycles. Primary outcome was the Pearl index, calculated using confirmed on-drug pregnancies and evaluable cycles in nonbreastfeeding women aged ≤ 35 years. We assessed adverse events (AEs), including hyperkalemia and v  ...[more]

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