Does Skyla Insertion Timing Impact Bleeding?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03074903

Enrollment

132

Registered

2017-03-09

Start date

2016-04-16

Completion date

2017-07-28

Last updated

2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Bleeding

Keywords

intrauterine device, bleeding

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.

Interventions

DEVICEIntrauterine system

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026