The SECURE Trial
Study Design
Pivotal clinical trial1
An open-label, 1-year, single-arm, multicenter trial enrolled 2,031 healthy, sexually active women aged 18–60. The primary efficacy analysis included 1,736 women.
5
.8
Pearl Index
(95% Cl, 4.5 – 7.2)
Patient Population
An inclusive and representative clinical trial1
Demographic Breakdown of Patients in Pivotal Clinical Trial (%)
| Demographic | SECURE trial† | U.S. Population2 |
|---|---|---|
| White | 67% | 75% |
| Asian | 4% | 6% |
| Black | 24% | 14% |
| Other | 6% | 4% |
| Hispanic | 19% | 20% |
| Non-Hispanic | 81% | 80% |
†
2031 women aged 18 to 60 participated in SECURE at 102 sites in 34 states.
Body Mass Index (BMI) Subgroup Breakdown (%)
| BMI | SECURE trial | U.S. Population |
|---|---|---|
| <25 kg/m2 | 39% | 33% |
| ≥25 to <30 kg/m2 | 25% | 27% |
| ≥30 kg/m2 | 35% | 40% |
Efficacy
Demonstrated pregnancy prevention1
Pearl Index Efficacy Analysis in Twirla-Treated Women by BMI Subgroup*
| BMI | Evaluable Cycles | Pearl Index (95% CI) |
|---|---|---|
| <25 kg/m2 | 6007 | 3.5 (1.8–5.2) |
| ≥25 to <30 kg/m2 | 3881 | 5.7 (3.0–8.4) |
| ≥30 kg/m2 | 5264 | 8.6 (5.8–11.5) |
*
Twirla is contraindicated in women with a BMI ≥ 30 kg/m2.
There is an increased pregnancy rate (i.e., the number of pregnancies per 100 woman-years), as BMI increases based on the primary analysis population (N=1,735).
