Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study

NCT01968135 ↗

Phase 2 Completed 32 enrolled University of Colorado, Denver

RandomizedParallel-groupDouble-blindTreatment

Summary

The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive implants who report a bleeding-spotting episode of at least seven days will stop bleeding within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to women receiving 14 days of placebo.

Timeline

Start: 2013-10
Primary completion: 2014-11
Completion: 2014-11

Outcome

Met primary endpoint

paper Participants randomized OCPs were more likely (14 of 16 [87.5%±16.2%] compared with six of 16 [37.5%±23.7%]) to have a temporary interruption of bleeding PMID 26181091 ↗

paper odds ratio 11.7, 95% confidence interval 1.9-70.2 PMID 26181091 ↗

paper Bothersome bleeding in etonogestrel contraceptive implant users will usually stop with 14-day OCP treatment PMID 26181091 ↗

Publications

Guiahi M, McBride M, Sheeder J, Teal S. Short-Term Treatment of Bothersome Bleeding for Etonogestrel Implant Users Using a 14-Day Oral Contraceptive Pill Regimen: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):508-513. doi: 10.1097/AOG.0000000000000974.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	0.15 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.03 mg	Oral