CClinicalTrials.gg
CompletedNCT03074903Updated Feb 13, 2018

Does Skyla Insertion Timing Impact Bleeding?

An observational study in Vaginal Bleeding, sponsored by Rutgers, The State University of New Jersey. Completed at 3 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Rutgers, The State University of New Jersey · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
132
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Vaginal Bleeding

Keywords

  • intrauterine device
  • bleeding
03

In context

Uterine Hemorrhage

156 studies on the registry are indexed under Uterine Hemorrhage; 19 are open to participants now.

This study's enrollment of 132 is close to the median of 121 across 40 observational studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women presenting for intrauterine device insertion.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
132 participants (actual)
Patient registry
No

Groups and cohorts

  • Early cycle insertion

    Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle.

    Device: Intrauterine system

  • Late cycle insertion

    Participants in this group have the intrauterine system inserted during the remainder of their cycle.

    Device: Intrauterine system

Interventions

  • DeviceIntrauterine system

    Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.

    Also known as: Intrauterine device

06

What researchers measure

Primary outcomes

  1. Bleeding and spotting as collected by daily texts

    Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion

    Time frame: 90 days

07

Study locations

3 sites
  • Planned Parenthood
    Morristown, New Jersey 07960, United States
  • NJFPC
    Newark, New Jersey 07103, United States
  • SHS
    Newark, New Jersey 07103, United States
08

References and documents

Publications

  • Shimoni N, Choudhury T, Goldman AR, Frondelli M, Chen PH. Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing. Contraception. 2019 Jun;99(6):340-344. doi: 10.1016/j.contraception.2019.02.004. Epub 2019 Mar 1. PubMed 30831104 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03074903
Lead sponsor
Rutgers, The State University of New Jersey
Responsible party
Noaa Shimoni (Assistant Professor, Family Medicine, NJMS, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Mar 9, 2017
Start date
Apr 16, 2016
Primary completion
Jul 27, 2017
Completion
Jul 28, 2017
Last update
Feb 13, 2018

Study contacts

Noa'a Shimoni, MD MPH
principal investigator · Rutgers University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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