contraceptives--postcoital and ulipristal

Emergency contraception is a woman's last chance to prevent unintended pregnancy. Ulipristal acetate, a selective progesterone receptor modulator, when taken as a single 30 mg dose, is a new, safe and effective emergency contraceptive that can be used from the first day and up to 5 days following unprotected intercourse. The older progesterone-only emergency contraceptive, levonorgestrel, is taken as two 0.75 mg pills 12 hours apart (Next Choice(®); Watson Pharmaceuticals Inc., Morristown, NJ, USA) or a single 1.5 mg pill (Plan B One-Step™; Watson Pharmaceuticals Inc.), and is approved for only 72 hours after unprotected intercourse. During clinical development, ulipristal acetate has been shown to be more effective than levonorgestrel in delaying or inhibiting ovulation. A recent meta-analysis of two randomized clinical trials showed ulipristal acetate to have a pregnancy risk 42% lower than levonorgestrel up to 72 hours and 65% lower in the first 24 hours following unprotected intercourse. Moreover, when taken beyond 72 hours, significantly more pregnancies were prevented with ulipristal acetate than with levonorgestrel. Side effects are mild and similar to those seen with levonorgestrel. Ulipristal acetate was approved for emergency contraception by the US Food and Drug Administration in August 2010, and has been launched in the USA as ella(®) (Watson Pharmaceuticals Inc.) since December 1, 2010. Ella is prescription only and is priced comparable to Plan B One-Step.

Topics: Administration, Oral; Contraception, Postcoital; Contraceptives, Oral, Synthetic; Contraceptives, Postcoital; Female; Humans; Levonorgestrel; Norpregnadienes; Ovulation Inhibition; Pregnancy; Pregnancy, Unwanted; Product Surveillance, Postmarketing; Time Factors; Treatment Outcome; Unsafe Sex

In recent years, there have been many updates in hormonal emergency contraception. Levonorgestrel emergency contraception has been available for several years to prevent pregnancy when used within 72 hours after unprotected intercourse or contraceptive failure, and it was recently approved for nonprescription status for patients aged 17 years or older. Current research suggests that the primary mechanism of action is delaying ovulation. Ulipristal is the newest emergency contraception, available by prescription only, approved for use up to 120 hours after unprotected intercourse or contraceptive failure. The primary mechanism of action is delaying ovulation. When compared with levonorgestrel emergency contraception, ulipristal was proven noninferior in preventing pregnancy. Evidence suggests that ulipristal does not lose efficacy from 72-120 hours; however, more studies are warranted to support this claim. Many misconceptions and controversies about hormonal emergency contraception still exist. Research does not support that increased access to emergency contraception increases sexual risk-taking behavior. Several studies suggest that health care providers, including pharmacists, could benefit from increased education about emergency contraception. It is important for pharmacists to remain up-to-date on the most recent hormonal emergency contraception products and information, as pharmacists remain a major point of access to emergency contraception.

Topics: Contraceptives, Postcoital; Humans; Levonorgestrel; Norpregnadienes; Patient Education as Topic; Unsafe Sex

Until recently, women in the UK who wanted emergency contraception had two options: an oral hormonal method (levonorgestrel), which is licensed for use up to 3 days after unprotected sexual intercourse; or a copper-bearing intrauterine device (IUD), which can be inserted up to 5 days after unprotected intercourse or up to 5 days after the earliest likely calculated ovulation. Now ulipristal acetate (ellaOne - HRA Pharma), a new oral hormonal emergency contraceptive, has been licensed in the European Union for use within 120 hours (5 days) of unprotected intercourse. Here we assess whether it is an advance for emergency contraception.

Topics: Administration, Oral; Adolescent; Adult; Aged; Contraceptives, Postcoital; Drug Costs; Female; Humans; Middle Aged; Norpregnadienes; Randomized Controlled Trials as Topic; Young Adult

Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception.. We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum beta-hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity.. Product efficacy was evaluable in 775 of CDB-2914 users and 774 of levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2-1.6%) and 13 (1.7%, 95% confidence interval 0.8-2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than levonorgestrel users (29% compared with 24%, P=.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths.. CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile.. I.

Topics: Adolescent; Adult; Contraceptives, Postcoital; Double-Blind Method; Female; Humans; Levonorgestrel; Norpregnadienes; Pregnancy; Pregnancy Rate

Topics: Body Mass Index; Contraception, Postcoital; Contraceptives, Postcoital; Female; Humans; Intrauterine Devices, Copper; Levonorgestrel; Norpregnadienes; Treatment Outcome

Topics: Contraception, Postcoital; Contraceptives, Postcoital; Emergency Medical Services; Female; Humans; Levonorgestrel; Norpregnadienes

Three methods of emergency contraception (EC) are currently available in Finland. Levonorgestrel (LNG) method (a single dose 1,5 mg of levonorgestrel within 72 hours after unprotected sexual intercourse (UPSI)) is available over-the-counter for people aged at least 15 years. Copper-IUD, inserted within 120 hours after UPSI is the most effective method, and availability of this method should be improved in primary health care. If time elapsed since UPSI is between 72 and 120 hours, and IUD cannot be inserted, ulipristal (30 mg as single dose) probably prevents pregnancy more effectively than LNG in this period of time.

Topics: Contraception, Postcoital; Contraceptives, Postcoital; Copper; Female; Finland; Humans; Intrauterine Devices; Levonorgestrel; Norpregnadienes; Practice Guidelines as Topic

Topics: Contraception, Postcoital; Contraceptives, Postcoital; Female; Humans; Levonorgestrel; Mifepristone; Norpregnadienes; Ovulation; Randomized Controlled Trials as Topic; Treatment Outcome

Emergency hormonal contraception (EHC) can reduce unintended pregnancy and the associated costs and consequences for the individual and National Health Service (NHS). Levonorgestrel (LNG 1.5 mg) is currently the standard of care in the UK; however, it is not licensed for use >72 hours after unprotected sexual intercourse (UPSI). This cost-effectiveness analysis compares LNG 1.5 mg with ulipristal acetate (UPA) (ellaOne(®)), a new emergency hormonal contraceptive that is licensed for use up to 120 hours post-UPSI. The costs of both drugs and the costs of the consequences of unintended pregnancy - namely miscarriage, induced abortion and birth - are compared in a decision model from the perspective of the UK NHS.. The incremental cost-effectiveness ratio (ICER) is the cost of preventing one additional unintended pregnancy with UPA and is calculated to be £311 compared to LNG 1.5 mg when taken up to 120 hours post-UPSI. In sensitivity analysis, looking at different time frames and costs, the ICER ranges from £183 to £500. All these costs are less than the estimated cost of an unintended pregnancy (£948) regardless of the outcome or the cost of an induced abortion (£672).. Even when considering only the direct costs of an unintended pregnancy, UPA represents value for money as a method of EHC when taken up to 120 hours post-UPSI. UPA is a cost-effective alternative to LNG 1.5 mg for all women presenting for EHC.

Topics: Contraceptive Agents, Female; Contraceptives, Postcoital; Cost-Benefit Analysis; Female; Humans; Levonorgestrel; Norpregnadienes; Pregnancy; Pregnancy, Unplanned; United Kingdom

Topics: Contraceptive Agents, Female; Contraceptives, Postcoital; Ethics, Medical; Female; Humans; Levonorgestrel; Norpregnadienes

Topics: Contraceptives, Postcoital; Drug Approval; Female; Humans; Levonorgestrel; Nonprescription Drugs; Norpregnadienes; Pregnancy; Sexual Behavior; United States; United States Food and Drug Administration