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Does Skyla Insertion Timing Impact Bleeding?

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ClinicalTrials.gov Identifier: NCT03074903
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Noaa Shimoni, Rutgers, The State University of New Jersey

Brief 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.

Condition or disease Intervention/treatment
Vaginal Bleeding Device: Intrauterine system

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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Skyla Insertion Timing Impact Bleeding?
Actual Study Start Date : April 16, 2016
Actual Primary Completion Date : July 27, 2017
Actual Study Completion Date : July 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: 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 Name: Intrauterine device




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women presenting for intrauterine device insertion.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074903


Locations
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United States, New Jersey
Planned Parenthood
Morristown, New Jersey, United States, 07960
NJFPC
Newark, New Jersey, United States, 07103
SHS
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Noa'a Shimoni, MD MPH Rutgers New Jersey Medical School

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Responsible Party: Noaa Shimoni, Assistant Professor, Family Medicine, NJMS, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03074903     History of Changes
Other Study ID Numbers: Pro20150001449
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Noaa Shimoni, Rutgers, The State University of New Jersey:
intrauterine device
bleeding

Additional relevant MeSH terms:
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Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female