Allergan announced the availability of Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, the first oral contraceptive in a softgel capsule for the prevention of pregnancy.
The efficacy of Taytulla, an estrogen/progestin combination oral contraceptive (COC), was assessed in a clinical study of 743 women. The women were aged 18—45 years and they participated in six 28-day cycles.
Among the 583 women who completed the 6 cycles of treatment, an accumulated total of 3,565 treatment cycles, there was a total of 5 on-treatment pregnancies in which no back-up contraception was used. The Pearl Index for norethindrone acetate/ethinyl estradiol capsules was 1.82 (95% CI: 0.59-4.25).
Contraindications for Taytulla use are those with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past. Efficacy in women with a body mass index of more than 35kg/m2 has not been evaluated.
Taytulla will be available in blister cards containing 24 soft gelatin capsules, each containing 1mg norethindrone acetate and 20mcg ethinyl estradiol, and 4 oval, opaque, maroon (nonhormonal placebo) capsules containing iron.
For more information visit Taytulla.com.