Does Skyla Insertion Timing Impact Bleeding?

NCT03074903 | Completed FDA Device

• 1 other identifier: Pro20150001449
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 3

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.

Conditions

Vaginal Bleeding

Keywords

intrauterine device; bleeding

Outcome Measures

Primary Outcomes (1)

• Bleeding and spotting as collected by daily texts

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

  90 days

Study Arms (2)

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

Intrauterine system DEVICE

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

Early cycle insertion; Late cycle insertion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women presenting for intrauterine device insertion.

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (3)

Planned Parenthood

Morristown, New Jersey, 07960, United States

Location

NJFPC

Newark, New Jersey, 07103, United States

Location

SHS

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

• 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.

  PMID: 30831104 DERIVED

MeSH Terms

Conditions

Uterine Hemorrhage; Hemorrhage

Interventions

Intrauterine Devices

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Study Officials

• Noa'a Shimoni, MD MPH

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Family Medicine, NJMS

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: March 9, 2017
• Study Start: April 16, 2016
• Primary Completion: July 27, 2017
• Study Completion: July 28, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)