NCT02852265

Brief Summary

Women currently using or starting a combined oral contraceptive will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate if they continue the COC, continue the implant, or both, and to assess adverse events and bleeding patterns.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 12, 2018

Completed
Last Updated

December 28, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

July 13, 2016

Results QC Date

March 27, 2018

Last Update Submit

December 6, 2018

Conditions

Contraception

Keywords

oral contraceptivecontraceptive implantcontraceptionadherenceadverse event

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)

    Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception

    6 months

  • Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)

    Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception

    6 months

Secondary Outcomes (4)

  • Patient Interest (Measurement: Ability to Enroll)

    6 months

  • Bleeding Patterns (Measurement: Diaries)

    6 months

  • COC Continuation Rate (Measurement: Participant Interview)

    6 months

  • Post-study Method Plan (Measurement: Participant Interview)

    6 months

Study Arms (1)

COC users or new starts

EXPERIMENTAL

Subjects will have a etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women starting a COC or recently started a COC within the past month will be considered new starts.

Drug: Etonogestrel contraceptive implant

Interventions

Etonogestrel contraceptive implantDRUG

Place nexplanon

Also known as: Nexplanon
COC users or new starts

Eligibility Criteria

Age16 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women being seen in a UC Davis medical office or who contact our research office.
  • Potential participants must be women currently COCs or intending to initiate COCs at the time of the office visit.

You may not qualify if:

  • Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria) will be excluded.
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Chen MJ, Hsia JK, Creinin MD. Etonogestrel implant use in women primarily choosing a combined oral contraceptive pill: A proof-of-concept trial. Contraception. 2018 Jun;97(6):533-537. doi: 10.1016/j.contraception.2018.02.009. Epub 2018 Feb 26.

    PMID: 29496473DERIVED

MeSH Terms

Interventions

etonogestrel

Results Point of Contact

Title
Dr. Melissa Chen
Organization
University of California, Davis
mejchen@ucdavis.edu
916-734-6670

Study Officials

  • Mitchell Creinin, MD

    Univeristy of California, Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

August 2, 2016

Study Start

September 15, 2016

Primary Completion

July 26, 2017

Study Completion

July 26, 2017

Last Updated

December 28, 2018

Results First Posted

July 12, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)