Does Skyla Insertion Timing Impact Bleeding?

February 12, 2018 updated by: Noaa Shimoni, Rutgers, The State University of New Jersey
Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Planned Parenthood
      • Newark, New Jersey, United States, 07103
        • NJFPC
      • Newark, New Jersey, United States, 07103
        • SHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women presenting for intrauterine device insertion.

Description

Inclusion Criteria:

  • Women aged 18-45
  • Parous or nulliparous
  • Desire Skyla for contraception
  • Regular menstrual cycles (21-35 days)
  • Working mobile phone and willing to accept text messages and report daily bleeding data for 90 days

Exclusion Criteria:

  • Vaginal or cesarean delivery in the past 12 weeks
  • Abortion in the past 6 weeks
  • Uterine anomaly distorting the uterus
  • Acute pelvic inflammatory disease
  • Uterine bleeding of unknown etiology
  • Acute liver disease or tumor
  • History of progestin-sensitive cancer
  • Abnormal pap smear awaiting diagnostic or therapeutic intervention

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early cycle insertion
Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle.
Device: Intrauterine system
Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.
Other Names:
  • Intrauterine device
Late cycle insertion
Participants in this group have the intrauterine system inserted during the remainder of their cycle.
Device: Intrauterine system
Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.
Other Names:
  • Intrauterine device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding and spotting as collected by daily texts
Time Frame: 90 days
Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Noa'a Shimoni, MD MPH, Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2016

Primary Completion (Actual)

July 27, 2017

Study Completion (Actual)

July 28, 2017

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro20150001449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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