Does Skyla Insertion Timing Impact Bleeding?

Completed

Conditions studied: Vaginal Bleeding

In brief

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.

Key facts

Study ID

NCT03074903

Run by

Rutgers, The State University of New Jersey

People needed

132

Starts

2016-04-16

Expected to finish

2017-07-28

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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