Levonorgestrel emergency contraception and bodyweight.

Objectives: Emergency contraception (EC) provides an opportunity to avoid an unwanted pregnancy following unprotected sexual intercourse (UPSI), failure of a regular contraceptive method, or after sexual assault. Two main methods are currently available: oral pills or the copper-T intrauterine device. In recent years there has been some debate regarding the efficacy of oral therapy in obese women. In this brief commentary we review new evidence, published after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) referral of 2014, relating to the effect of obesity on the pharmacokinetics and clinical efficacy of levonorgestrel EC in light of some of the concerns that have been raised. Methods: A PubMed literature search ("levonorgestrel" and "emergency contraception") was conducted between 1 January 2005 to 31 March 2018; results from the main clinical trials are discussed. Additional literature known to the authors and identified from the reference lists of cited publications was included. Results: Overall, it should be noted that, in studies which determined pregnancy rates across different weight or BMI categories, the overall pregnancy rate was low (1-2%) and there was no direct evidence that lower levonorgestrel plasma levels contributed to an increased pregnancy rate in obese women. This conclusion was reached by the EMA referral in 2014 and they concluded that emergency contraceptive pills (ECPs) could be taken regardless of body weight or BMI, as soon as possible after UPSI. Since the EMA review, additional evidence has been published regarding this topic. This includes PK data (which can neither support, nor deny the previously submitted meta-analyses during the Article 31 Referral procedure), or re-analyses of the previously submitted data. Conclusions: Evidence published since the EMA referral in 2014 does not change the original conclusions of the agency, which recommended that ECPs could be taken regardless of body weight or BMI, as soon as possible after UPSI.

Needs and preferences of women users of oral contraceptives in selected countries in Central and Eastern Europe.

BACKGROUND: The availability of various oral contraceptive (OC) pill formulations with different hormone compositions suggests that there is potential to align a particular product with an individual user's needs and preferences. To explore this concept further, a survey was conducted of current users of OCs to define and confirm areas of specific needs, and to gain insight into their views and preferences for OC formulations. METHODS: During November and December 2015, women users (n=615) of OCs in five Central and Eastern European countries were surveyed in face-to-face interviews conducted by experienced interviewers. The survey questionnaire comprised 34 questions about the use of and specific needs for OCs. RESULTS: Four basic needs of women taking OCs were identified: reliable contraception, reversibility of contraception, no effect on body weight and safety. Overall, 85% of surveyed women indicated that prevention of pregnancy was the main reason for taking OCs. Weight gain was the side effect of greatest concern with OC use (46% spontaneous answer; 65% aided answer). Independent behavioural segmentation analysis identified four groups - Solved Cycle Problems (46% of participants), Low Hormone Content (22%), Lifestyle (17%) and Beauty (14%) - which characterised the women according to needs and preferences beyond the basic needs of OCs. Each group had unique features and distinct preferences for different formulations of OCs. CONCLUSIONS: Aligning product advantages with specific individual needs may enhance users' overall experience with OCs as a contraceptive option.