MedTrace Logo

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

NCT01963403 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-05-12

Study results available
· View outcomes & findings →

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

Conditions

  • Abnormal Uterine Bleeding, Unspecified
  • Uterine Bleeding Heavy

Interventions

DRUG

EE 30mcg/LNG 150mcg

1 pill per day; daily during study participation (up to 84 days)

DRUG

Placebo

1 pill per day; daily during study participation (up to 84 days)

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Mitchell Creinin, MD · University of California, Davis

  • Melody Hou, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01963403 on ClinicalTrials.gov