SECURE TRIAL

A new approach to CHC clinical trials

The Twirla® pivotal study–the SECURE Trial–was intentionally designed to include broad enrollment criteria and a patient population of women likely to use hormonal contraceptives.1

Study Design

The efficacy, safety, and tolerability of Twirla were evaluated in a 12-month, open-label, single-arm, multicenter trial in the US that enrolled 2031 women ranging in age from 18 to 60 years who were healthy and sexually active with regular menstrual cycles. The primary efficacy analysis included data from 1736 women between the ages of 18 and 35 years who completed 15,165 evaluable 28-day cycles with Twirla, where no back-up contraception was used and sexual intercourse occurred.

Consider the reduced effectiveness of Twirla in women with a BMI ≥25 to <30 kg/m2 before prescribing. 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).

CHC=combined hormonal contraceptive; SECURE=Study to Evaluate Contraceptive Use, Reliability, and Effectiveness.


A representative and inclusive trial population

The SECURE Trial’s broad enrollment criteria led to a diverse study population closely representative of the demographics of women across the US.1,3

Consider the reduced effectiveness of Twirla in women with a BMI ≥25 to <30 kg/m2 before prescribing. 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).

IMPORTANT SAFETY INFORMATION

+

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).