A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)
Merck Sharp & Dohme Corp.
The primary purpose of this study is to investigate the contraceptive efficacy, safety and
acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in
various countries in order to obtain country-specific data.
Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
University of Utah
A highly effective single rod contraceptive implant is now available for use in the US.
Delays in the insertion of the device until later in the postpartum period may negatively
impact initiation rates. The objective of this study is to compare outcomes of early
postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing
contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary
outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of
breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side
effects, time to resume sexual intercourse after delivery, and incidence of missed routine
postpartum follow-up. In addition, a subset of patients who randomize to early postpartum
insertion will have expressed breastmilk ascertained for nutrient composition.
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