drugset / Trial / NCT01963403

Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive

NCT01963403

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant. The hypothesis of the study is: * Use of combined oral contraceptive will significantly improve bleeding patterns for users of ETG implant * Continuation rate of ETG implant users will be increased by use of combined oral contraceptive in women desiring ETG implant removal because of the undesirable bleeding * Adverse events will be uncommon and acceptable to women who use a combined oral contraceptive with the ETG implant

Timeline

Start
2013-12
Primary completion
2015-07
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levonorgestrel Small molecule 150 ug Oral
Comparator ethinyl estradiol Small molecule 30 ug Oral

Indications