Secondary Logo

Journal Logo

Institutional members access full text with Ovid®

Efficacy of LF111, an Investigational, Drospirenone-Based Progestogen Oral Contraceptive [10J]

Kimble, Thomas Dudley MD; Burke, Anne E. MD, MPH; Barnhart, Kurt T. MD; Colli, Enrico MD; Archer, David F. MD

doi: 10.1097/01.AOG.0000558826.49527.6e
Saturday, May 4, 2019
Buy

INTRODUCTION: Progestogen only oral contraceptives are associated with a decreased risk of venous thromboembolism making them indicated in women who are breast feeding or present contraindications to estrogens, including obesity, age > 35 years and smokers. Drospirenone (DRSP), a progestogen derived from spironolactone with a pharmacological profile similar to natural progesterone possesses anti-mineralocorticoid and anti-androgenic activity.

METHODS: Multicenter, open-label trial in sexually active females ≥15 years seeking contraception were administered LF111 (4.0 mg DRSP: x 24 days with x 4 placebo tablets) in 13 sequential cycles of 28 days each. The Pearl Index (PI) was calculated in evaluable cycles in the overall population (Full Analysis Set [FAS]) and in non-breastfeeding women (modified FAS; [mFAS]) aged ≤35 at the time of enrollment, who received at least one dose of LF111, excluding discontinued sites.

RESULTS: The FAS and mFAS comprised 1004 and 993 subjects, respectively. The PI in 5337 evaluable cycles in 903 non-breastfeeding subjects with 12 confirmed on-drug pregnancies was 2.9 (95% CI 1.5-5.1). The overall PI in 5835 exposure cycles in 903 subjects with 12 confirmed pregnancies was 2.7 (95% 1.4-4.7). The PI for method failures in 2664 perfect cycles in 908 subjects with 7 pregnancies was 3.4 (95% CI 1.4-7.0). There were no pregnancies in women >35 years.

CONCLUSION: The primary endpoint, PI from evaluable cycles in non-breastfeeding women age ≤35 years at the time of enrollment, showed that LF111 provided effective contraception protection with a PI of 2.9., historically comparable to recently approved combined oral contraceptives.

Eastern Virginia Medical School, Norfolk, VA

Financial Disclosure Thomas Kimble disclosed the following—Exeltis: Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support, Principal Investigator. Anne Burke disclosed the following—Exeltis: Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support, Principal Investigator. Kurt Barnhart disclosed the following—Exeltis: Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support, Principal Investigator. Enrico Colli disclosed the following—Exeltis: Employment. David F. Archer disclosed the following—AbbVie: Consultant/Advisory Board, Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support; Agile: Consultant/Advisory Board, Ownership Interest includes stock, stock options, patent or other intellectual property. Bayer: Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support; Endoceutics: Consultant/Advisory Board, Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support. Exceltis: Consultant/Advisory Board; Myovant: Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support; Obs-Eva: Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support; TherapeuticsMD: Consultant/Advisory Board, Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support.

© 2019 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.