Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, uniplant

Elsimar M. Coutinho, Jose Carlos De Souza, Celia Athayde, Ione C. Barbosa, Francisco Alvarez, Vivian Brache, Gu Zhi-Ping, Edward E. Emuveyan, Adeyemi O. Adekunle, Luigi Devoto, Mamdouh M. Shaaban, Hosam T. Salem, Biran Affandi, Oscar Mateo De Acosta, Japheth Mati, Oladapo A. Ladipo

Research output: Contribution to journalArticlepeer-review

38 Citations (Scopus)

Abstract

Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.

Original languageEnglish
Pages (from-to)121-125
Number of pages5
JournalContraception
Volume53
Issue number2
DOIs
Publication statusPublished - 1 Jan 1996

Keywords

  • single contraceptive implant Uniplant

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