Drug Information for SEASONIQUETM (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg and (ethinyl estradiol tablets) 0.01 mg (DURAMED PHARMACEUTICALS, INC.): INDICATIONS AND USAGE

  • SeasoniqueTM tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

  • Clinical Studies

  • PSE-301 was a randomized, multicenter, open-label study designed to evaluate the safety and efficacy of SeasoniqueTM for approximately 1 year (four 91-day SeasoniqueTM 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 SeasoniqueTM 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.

    Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

    Table 2: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States.
    % of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.
    Method (1)Typical Use

    Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an unintended pregnancy during the first year if they do not stop use for any other reason.

    Perfect Use

    Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an unintended pregnancy during the first year if they do not stop use for any other reason.

    ChanceThe percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.8585
    SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.26640
    Periodic abstinence2563
    Ovulation method3
    Sympto-thermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2
    CapWith spermicidal cream or jelly.
    Parous women402642
    Nulliparous women20956
    Parous women402042
    Nulliparous women20956
    CondomWithout spermicides.
    Female (Reality)21556
    Progestin only0.5
    Progesterone T2.01.581
    Copper T 380A0.80.67
    LNg 200.10.181
    Norplant and Norplant-20.050.0588
    Female sterilization0.50.5100
    Male sterilization0.150.10100
    Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
    Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced or the baby reaches six months of age.

    Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition, New York NY: Irvington Publishers, 1998.

  • Drug Information Provided by National Library of Medicine (NLM).