Regulatory challenges of new male contraceptive methods.

Introduction: Progress in male contraception development faces the challenge of a lack of regulatory precedent and guidelines on the evidence (trial design and primary endpoint) required for marketing approval. Moreover, the development of a male contraceptive is complicated by the fact that the clinical treatment effect; prevention of pregnancy, is not measured in the patient receiving the intervention.

Discussion: Regulatory precedent and guidelines exist for female hormonal contraceptives but their applicability to male contraceptive products likely varies based on the mode of action and the anticipated pharmacodynamic effects of the product.

The impact of the boxed warning on the duration of use for depot medroxprogesterone acetate.

Objective: The objective of this study was to examine the impact of the Food and Drug Administration's boxed warning on the utilization of depot medroxyprogesterone (DMPA).

Methods: From the IMS Lifelink data (2001-2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6 months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90-day DMPA or 30-day CHC between claims.

Effect of obesity on the effectiveness of hormonal contraceptives: an individual participant data meta-analysis.

Objective: The objective of this investigation was to assess the potential effect of obesity on the effectiveness of hormonal contraceptives (HCs).

Study Design: A meta-analysis was conducted using individual participant data directly from the Phase 3 clinical trials of combination oral contraceptives (COCs) rather than extracting summary data from literature. Trials selected were reviewed by the US Food and Drug Administration (FDA) between 2000 and 2012, conducted in North America, had more than six 28-day cycle equivalents of exposure, and had readily retrievable participant-level data.

Glucose tolerance and risk of gestational diabetes mellitus in nulliparous women who smoke during pregnancy.

Gestational diabetes mellitus has been associated with adverse maternal and infant outcomes, including preeclampsia and fetal macrosomia. Although cigarette smoking has been associated with increased insulin resistance, its effect on gestational diabetes mellitus risk is uncertain. The authors evaluated the effects of smoking on glucose tolerance in a cohort of pregnant women who participated in the Calcium for Preeclampsia Prevention trial, a randomized study of nulliparous women conducted in five US medical centers from 1992 to 1995.