Completed

Home or Office Visit for Insertion of Etonogestrel Implant: A Pilot Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Home Visit

+ Office visit

Procedure
Who is being recruted

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorCase Western Reserve University
Last updated: January 28, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

This is a pilot study in which women who desire an etonogestrel implant will be randomized to either a home or office insertion visit. The purpose of this research is to study the interest in, feasibility of, and rates of insertion for implantable birth control (Implanon®/Nexplanon®) when inserted at home visit appointments compared to standard office visit appointments. The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel implant and increase consistent and correct contraception use by introducing a previously unexplored method of access, the home visit.

NCT01816932
Principal SponsorCase Western Reserve University
Last updated: January 28, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
Has a safe and private location in the home for the implant to be inserted
Has running water and a working bathroom in the home
Interested in using the etonogestrel implant for contraception
Presenting to University Hospitals for delivery or contraception
Show More Criteria
10 exclusion criteria prevent from participating
Allergic reaction to components (ethylene vinylacetate, etonogestrel, barium sulfate) of etonogestrel implant or local anesthetics
Current or history of thrombosis or thromboembolic disorders
Housing located greater than 10 miles from University Hospitals Center for Women's Health
Known or suspected breast cancer or history of breast cancer
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
20 participants will be randomized to receive a home visit for the insertion of their implantable birth control rather than the standard office visit.

Group II

Placebo
20 participants will be randomized to receive an office visit (standard of care).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospitals

Cleveland, United StatesOpen University Hospitals in Google Maps
CompletedOne Study Center