Does Skyla Insertion Timing Impact Bleeding?

Vaginal Bleeding Clinical Trial

Official title:

Does Skyla Insertion Timing Impact Bleeding?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074903
• Other study ID #: Pro20150001449
• Status: Completed
• Phase: N/A
• First received: February 6, 2017
• Last updated: February 12, 2018
• Start date: April 16, 2016
• Est. completion date: July 28, 2017

Study information

• Verified date: February 2018
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 28, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Uterine Hemorrhage
• Vaginal Bleeding

Intervention

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

Locations

Country	Name	City	State
United States	Planned Parenthood	Morristown	New Jersey
United States	NJFPC	Newark	New Jersey
United States	SHS	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding and spotting as collected by daily texts	Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion	90 days