CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Etonogestrel implantdrug
Likely dose
Etonogestrel implantAI-extracted
Key inclusion· 4
  • Age 12-40 years
  • Delivery at Duke Hospital
  • Has working telephone number
  • No contraindications to etonogestrel implant, including: no known/suspected pregnancy, no active liver disease or hepatic tumor, no history of thrombosis or thromboembolic disorder, no undiagnosed abnormal genital bleeding, no known/suspected or prior breast cancer, no hypersensitivity to device components
Key exclusion· 5
  • Use of non-nucleoside reverse transcriptase inhibitors (NNRTIs)
  • Use of ritonavir-boosted protease inhibitors
  • Use of certain anticonvulsants: phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine
  • Use of rifampin

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01767285
NCT01767285Phase 4Completed

A Randomized Controlled Trial of Immediate Postpartum Etonogestrel Implant Versus Six-week Postpartum Etonogestrel Implant: A Pilot Study

Duke University·interventional·Posted Jan 14, 2013·Updated Feb 28, 2017

In Brief

A Phase 4 clinical trial evaluating Etonogestrel implant for Continuation Rate of Contraceptive Implant. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2013
Enrollment StartJan 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.5 years ago

Interventions

Etonogestrel implantdrug

This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.