Does Skyla Insertion Timing Impact Bleeding?

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.

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Key information

Conditions

Vaginal Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood, Morristown, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrauterine system

Device

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

Other names: Intrauterine device

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Mar 9, 2017
Registry last updated: Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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