Does Skyla Insertion Timing Impact Bleeding?

Rutgers The State University of New Jersey

Status: Completed

Conditions: Vaginal Bleeding

Treatments: Device: Intrauterine system

Study type: Observational

Funder types: Other

Identifiers

NCT03074903

Pro20150001449

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

132 participants in 2 patient groups

Early cycle insertion

Description:

Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle.

Treatment:

Device: Intrauterine system

Late cycle insertion

Description:

Participants in this group have the intrauterine system inserted during the remainder of their cycle.

Treatment:

Device: Intrauterine system