DEMONSTRATED EFFICACY

Demonstrated pregnancy prevention

In the SECURE Trial, there were no restrictions on BMI at enrollment, providing you and your patients with comprehensive efficacy and safety data to inform shared decision making.

The primary efficacy endpoint in the SECURE trial was the Pearl Index (PI), defined as the pregnancy rate per 100 woman-years of use. The overall PI of Twirla® was 5.8 (95% CI, 4.5-7.2). There were clear differences in efficacy by BMI categories.

In the SECURE Trial, Twirla was 95% effective in preventing pregnancy, which is consistent with other combined hormonal contraceptives.2



Pregnancy rates across a range of BMIs

Efficacy data for Twirla are available across a range of BMIs, which can help inform patient discussions.

*Plot is based on Poisson Model with continuous BMI as the predictor (N=1735); one woman in the primary analysis population had no BMI information. The solid line displays the estimated pregnancy rate, and the shaded area displays the 95% confidence interval for the estimated pregnancy rate.

Effectiveness consistent with other tier 2 combined hormonal contraceptives (CHC)1,2

*The pregnancy rate in women aged 18-35 years was 5.29% (4.17-6.70) per 100 woman-years of patch use when used as directed.1

Hormonal birth control methods help lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

References: 1. Data on file, Clinical Study Report 023; Agile Therapeutics. 2. Trussell J, Aiken ARA, Micks E, Guthrie KA. Efficacy, safety, and personal considerations. In: Hatcher RA, Nelson AL, Trussell J, et al, eds. Contraceptive Technology. 21st ed. New York, NY: Ayer Company Publishers; 2018:95-128.

IMPORTANT SAFETY INFORMATION

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WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 kg/m2

Cigarette Smoking and Serious Cardiovascular Events
Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.
Contraindicated in Women with a BMI ≥30 kg/m2
TWIRLA is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events (VTEs).