Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials

Fertility and Sterility
Philip DarneyAndrew M Kaunitz

Abstract

To present efficacy, safety, and bleeding profile results from the clinical trials that supported the U.S. Food and Drug Administration filing for the approval of a single-rod etonogestrel (ENG) contraceptive implant (Implanon). Integrated analysis of 11 international clinical trials. Contraceptive clinics in U.S., Chile, Asia, and Europe. A total of 942 healthy women, aged 18 to 40 years. Insertion of an ENG implant. Most women were enrolled in studies lasting either 2 or 3 years. Efficacy was measured by the cumulative Pearl Index in women <or=35 years old. Safety was primarily assessed by incidence of adverse events. Bleeding profiles were analyzed via reference period analyses. No pregnancies were reported while the ENG implants were in place. Six pregnancies occurred during the first 14 days after ENG implant removal. Including these six pregnancies, the cumulative Pearl Index was 0.38 (year 1 and 2 Pearl Indexes were 0.27 and 0.30, respectively). Common drug-related adverse events were headache, weight gain, acne, breast tenderness, emotional lability, and abdominal pain. Bleeding pattern changes were observed, but no one pattern predominated. The ENG implant is an efficacious and safe method of contraception which does n...Continue Reading

Citations

Nov 5, 2009·Journal of General Internal Medicine·Eleanor Bimla SchwarzJames Trussell
Jul 17, 2010·Human Reproduction Update·P D BlumenthalK Gemzell-Danielsson
Jul 5, 2011·International Journal of Adolescent Medicine and Health·Amit M DeokarHatim A Omar
Jun 15, 2011·American Journal of Clinical Dermatology·Aurélie Du-ThanhBernard Guillot
Jun 15, 2011·Drugs·Amy StoddardJeffrey F Peipert
Jul 16, 2014·Clinics in Dermatology·Charlene Lam, Andrea L Zaenglein
Jan 16, 2014·Hand : Official Journal of the American Association for Hand Surgery·Joshua M Adkinson, Jay S Talsania
Jul 28, 2015·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Costantino Di CarloCarmine Nappi
Feb 22, 2012·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Stefano PalombaFulvio Zullo
Apr 9, 2013·Expert Opinion on Drug Safety·Carolina ScalaSimone Ferrero
Dec 18, 2013·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·Anna Maria TeunissenFrans J M E Roumen
Nov 30, 2013·Obstetrics and Gynecology Clinics of North America·Anitra Beasley, Ann Schutt-Ainé
Apr 3, 2013·The Journal of Adolescent Health : Official Publication of the Society for Adolescent Medicine·Jennefer A RussoMelanie A Gold
Jun 12, 2012·Contraception·Ashlesha PatelUNKNOWN Society of Family Planning
Jan 18, 2012·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Regis KreitchmannGisele Maria Inchauspe Preussler
Nov 6, 2010·Women's Health Issues : Official Publication of the Jacobs Institute of Women's Health·Erica L SpiesMary Losch
Apr 12, 2011·Contraception·Petra M CaseyJessica E Bury
Nov 26, 2010·Journal of Pediatric and Adolescent Gynecology·Michelle Isley
Nov 17, 2009·Contraception·Milena Bastos BritoCarolina Sales Vieira
May 3, 2013·The Australian & New Zealand Journal of Obstetrics & Gynaecology·Carolyn S Mwalwanda, Kirsten I Black
Nov 26, 2015·Obstetrics and Gynecology Clinics of North America·EmmaKate Friedlander, Bliss Kaneshiro
Apr 24, 2016·Journal of Obstetrics and Gynaecology Canada : JOGC = Journal D'obstétrique Et Gynécologie Du Canada : JOGC·Amanda BlackAnne Marie Whelan
Apr 24, 2016·Journal of Obstetrics and Gynaecology Canada : JOGC = Journal D'obstétrique Et Gynécologie Du Canada : JOGC·Amanda BlackAnne Marie Whelan
Mar 18, 2015·Women's Health·Natalie Whaley, Anne Burke
Oct 23, 2013·Journal of Controlled Release : Official Journal of the Controlled Release Society·Amit AlexanderShailendra Saraf
Jan 4, 2015·American Journal of Obstetrics and Gynecology·Abbey B BerensonJacqueline M Hirth
Nov 15, 2011·Journal de gynécologie, obstétrique et biologie de la reproduction·A Vincent-RohfritschN Chabbert-Buffet
Jul 6, 2014·Best Practice & Research. Clinical Obstetrics & Gynaecology·Roy Jacobstein, Chelsea B Polis
Mar 1, 2015·Current Obstetrics and Gynecology Reports·Bliss Kaneshiro, Jennifer Salcedo
May 27, 2016·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·Conrado S RagaziniCarolina Sales Vieira
Jun 15, 2016·The Journal of Pediatrics·Allison H Eliscu, Gale R Burstein
Jan 4, 2017·Contraception·Priscilla de Nazaré Silva Dos SantosJeffrey F Peipert
Mar 28, 2017·American Journal of Obstetrics and Gynecology·Jennifer L EggebrotenDavid K Turok
Mar 5, 2016·The Journal of Family Planning and Reproductive Health Care·Kumiyo InoueJuliet Richters
Mar 20, 2018·Journal of Obstetrics and Gynaecology : the Journal of the Institute of Obstetrics and Gynaecology·Esther López Del CerroGaspar González de Merlo

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