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Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill.
Acta Obstet Gynecol Scand 2019; 98(12):1549-1557AO

Abstract

INTRODUCTION

Approximately 100 million women currently use combined oral contraceptives. Combined oral contraceptives use is associated with increased risk of venous thromboembolic events and cardiovascular disease. Progestin-only pills do not increase the risk of venous thromboembolic events, stroke and myocardial infarction but are associated with a poor cycle control. A novel estrogen-free pill containing only drospirenone (DRSP) was developed to improve bleeding pattern, tolerability and acceptance without increasing venous thromboembolic events risks in contraception.

MATERIAL AND METHODS

Two prospective, multicenter Phase III studies in healthy women aged 18-45 years were performed to demonstrate the efficacy and safety of a drospirenone-only pill in a regimen of 24 days of 4 mg of drospirenone tablets followed by 4 days of placebo. A total of 1571 women (14 329 exposure cycles) were analyzed: 713 patients in the 13-cycle study 1 with 7638 exposure cycles and 858 patients in the 9-cycle study 2 with 6691 exposure cycles. The primary endpoint was the overall Pearl index, calculated for each study separately, and for both pooled. As main secondary efficacy endpoint, the "method failure Pearl index" including all pregnancies during "perfect medication cycles" was evaluated. EudraCT registration numbers: 2010-021787-15 & 2011-002396-42.

RESULTS

Calculations on pooled studies 1 and 2 with 1571 patients gave an overall Pearl index (based on 14 329 cycles) of 0.7258 (95% CI 0.3133 to 1.4301). No single case of deep vein thrombosis or pulmonary embolism and only one case of hyperkalemia were reported. Additional information such as laboratory parameters, body mass index, bodyweight, heart rate and blood pressure showed no statistically significant changes due to the treatment.

CONCLUSIONS

This is the first report of a new drospirenone-only oral contraceptive providing clinical efficacy similar to combined oral contraceptives, with a good safety profile, and favorable cycle control.

Authors+Show Affiliations

Instituto Palacios, Salud y Medicina de la Mujer, Madrid, Spain.Exeltis HealthCare Madrid, Madrid, Spain.Exeltis Europe, Ismaning, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31321765

Citation

Palacios, Santiago, et al. "Multicenter, Phase III Trials On the Contraceptive Efficacy, Tolerability and Safety of a New Drospirenone-only Pill." Acta Obstetricia Et Gynecologica Scandinavica, vol. 98, no. 12, 2019, pp. 1549-1557.
Palacios S, Colli E, Regidor PA. Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. Acta Obstet Gynecol Scand. 2019;98(12):1549-1557.
Palacios, S., Colli, E., & Regidor, P. A. (2019). Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. Acta Obstetricia Et Gynecologica Scandinavica, 98(12), pp. 1549-1557. doi:10.1111/aogs.13688.
Palacios S, Colli E, Regidor PA. Multicenter, Phase III Trials On the Contraceptive Efficacy, Tolerability and Safety of a New Drospirenone-only Pill. Acta Obstet Gynecol Scand. 2019;98(12):1549-1557. PubMed PMID: 31321765.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. AU - Palacios,Santiago, AU - Colli,Enrico, AU - Regidor,Pedro-Antonio, Y1 - 2019/08/06/ PY - 2019/04/12/received PY - 2019/06/24/revised PY - 2019/06/27/accepted PY - 2019/7/20/pubmed PY - 2019/7/20/medline PY - 2019/7/20/entrez KW - Pearl index KW - drospirenone KW - drospirenone-only pill KW - estrogen-free contraception KW - venous thromboembolic events SP - 1549 EP - 1557 JF - Acta obstetricia et gynecologica Scandinavica JO - Acta Obstet Gynecol Scand VL - 98 IS - 12 N2 - INTRODUCTION: Approximately 100 million women currently use combined oral contraceptives. Combined oral contraceptives use is associated with increased risk of venous thromboembolic events and cardiovascular disease. Progestin-only pills do not increase the risk of venous thromboembolic events, stroke and myocardial infarction but are associated with a poor cycle control. A novel estrogen-free pill containing only drospirenone (DRSP) was developed to improve bleeding pattern, tolerability and acceptance without increasing venous thromboembolic events risks in contraception. MATERIAL AND METHODS: Two prospective, multicenter Phase III studies in healthy women aged 18-45 years were performed to demonstrate the efficacy and safety of a drospirenone-only pill in a regimen of 24 days of 4 mg of drospirenone tablets followed by 4 days of placebo. A total of 1571 women (14 329 exposure cycles) were analyzed: 713 patients in the 13-cycle study 1 with 7638 exposure cycles and 858 patients in the 9-cycle study 2 with 6691 exposure cycles. The primary endpoint was the overall Pearl index, calculated for each study separately, and for both pooled. As main secondary efficacy endpoint, the "method failure Pearl index" including all pregnancies during "perfect medication cycles" was evaluated. EudraCT registration numbers: 2010-021787-15 & 2011-002396-42. RESULTS: Calculations on pooled studies 1 and 2 with 1571 patients gave an overall Pearl index (based on 14 329 cycles) of 0.7258 (95% CI 0.3133 to 1.4301). No single case of deep vein thrombosis or pulmonary embolism and only one case of hyperkalemia were reported. Additional information such as laboratory parameters, body mass index, bodyweight, heart rate and blood pressure showed no statistically significant changes due to the treatment. CONCLUSIONS: This is the first report of a new drospirenone-only oral contraceptive providing clinical efficacy similar to combined oral contraceptives, with a good safety profile, and favorable cycle control. SN - 1600-0412 UR - https://www.unboundmedicine.com/medline/citation/31321765/Multicenter,_phase_III_trials_on_the_contraceptive_efficacy,_tolerability_and_safety_of_a_new_drospirenone_only_pill L2 - https://doi.org/10.1111/aogs.13688 DB - PRIME DP - Unbound Medicine ER -