FDA Approved Drugs » 2003
Medical Areas: Obstetrics/Gynecology (Women’s Health)
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Duramed Pharmaceuticals
Approval Status: Approved September 2003
Treatment Area: contraception
Seasonal, Seasonique, LoSeasonique is an extended-cycle oral contraceptive consisting of levonorgestrel, a synthetic progestogen and ethinylestradiol, an orally active semisynthetic steroidal estrogen. Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and changes in the endometrium (which reduce the likelihood of implantation).
The estrogen/progestin combination oral contraceptive is specifically indicated for use by women to prevent pregnancy. It is supplied as a tablet for oral administration
The combination oral contraceptive is formulated as: Seasonale (84 active tablets containing 0.15 mg levonorgestrel plus 0.03 mg ethinylestradiol and 7 inactive tablets) taken daily for 91 consecutive days; Lo Seasonique (84 active tablets containing 0.1 mg levonorgestrel plus 0.02 mg ethinylestradiol and 7 inactive tablets) taken daily for 91 days and Seasonique (84 active tablets containing 0.15 mg of levonorgestrel plus 0.03 mg of ethinyl estradiol and 7 inactive tablets), taken daily for 91 consecutive days.
FDA ApprovalSeasonaleThe FDA approval of Seasonale was based on a one year controlled study in 809 women 18-35 years of age. No backup contraception was utilized and four pregnancies occured. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 1.98 per 100 women-years of use.LoSeasoniqueThe clinical data supporting the LoSeasonique NDA resulted from a 12-month, multi-centered, open label clinical trial that concluded in June 2007. The clinical trial involved over 2,100 female subjects between the ages of 18 and 41 at 56 sites throughout the United States, and subjects completed an equivalent of nearly 21,000 28-day cycles of exposure. The most common adverse events in the clinical trial were headache, irregular and/or heavy uterine bleeding, dysmenorrhea, nausea and/or vomiting, and back pain.Seasonique
The FDA approval of Seasonique was based on PSE-301, a randomized, multicenter, open-label study designed to evaluate the safety and efficacy of Seasonique for approximately 1 year (four 91-day Seasonique extended cycles). A total of 1,006 sexually active adult women of childbearing potential, 18 to 40 years of age, were treated and completed 2,488 Seasonique 91-day cycles. The principal cohort for efficacy included only patients 18 to 35 years of age who completed at least one 91-day cycle treatment cycle. Cycles in which another form of birth control was used (including condoms) were excluded from the efficacy analysis. The overall Pearl Index was 1.77, based on 7 pregnancies in 1,578 completed 91-day treatment cycles.
Adverse events associated with the use of the combined oral contraceptive may include, but are not limited to, the following:
For additional information regarding Seasonale or Seasonique, please visit the Seasonique web page.
For additional information regarding LoSeasonale, please visit the LoSeasonique web page.
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