Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 2013

Specific Treatments:

contraception

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General Information

Quarette is an ascending-dose, extended regimen oral contraceptive comprised of levonorgestrel/ethinyl estradiol and ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen. Quarette prevents conception primarily by suppressing ovulation. It may also induce cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Quartette is specifically indicated for use by females of reproductive age to prevent pregnancy.

Quartette is supplied as ascending dose tablets for oral administration. Quartette should be administered once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Quartette must be taken exactly as directed and at intervals not exceeding 24 hours.

Clinical Results

FDA Approval
The FDA approval of Quartette was based on a phase III trial in 3,565 women, 18-40 years old, who were treated for up to four 91-day cycles (thirteen 28-day cycles). The pregnancy rate (Pearl Index [PI]) in women aged 18-35 years was 3.19 pregnancies per 100 woman-years of use, based on 70 pregnancies that occurred after the onset of treatment and up to and including 7 days after the last pill (97% efficacy rate). Breakthrough bleeding and unscheduled spotting also decreased over successive 91 day cycles.

Side Effects

Adverse events associated with the use of Quartette may include, but are not limited to, the following:

  • headaches
  • heavy/irregular vaginal bleeding
  • nausea/vomiting
  • acne
  • dysmenorrhea
  • weight increased
  • mood changes
  • anxiety/panic attack
  • breast pain
  • migraines

Mechanism of Action

Quarette is an ascending-dose, extended regimen oral contraceptive comprised of levonorgestrel/ethinyl estradiol and ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen. Quarette prevents conception primarily by suppressing ovulation. It may also induce cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Additional Information

For additional information regarding Quartette or contraceptives, please visit the Teva Pharmaceuticals web page.