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Bleeding Data With Kyleena® IUD

Counsel your patients that they may experience shorter, lighter periods after the first 3 to 6 months with Kyleena1

  • In the first 3 to 6 months of Kyleena use, patients may find that their number of bleeding and spotting days is higher and their bleeding patterns are irregular
  • After 6 months, the number of bleeding and spotting days continued to decline for most women using Kyleena

Mean number of bleeding and spotting days over the course of 5 years1

Mean number of bleeding and spotting days over the course of 5 years. Mean number of spotting days. Mean number of bleeding days. Cycle (28 days). Number of Women. 8.6, 7.2, 1, 1619. 4.6, 3.2, 4, 1575. 3.5, 2.2, 7, 1518. 2.9, 1.5, 13 (1 year), 1394. 2.2, 1, 39 (3 years), 913. 2.1, 0.9, 65 (5 years), 322.

Some patients experienced amenorrhea and infrequent bleeding over 5 years1

Bleeding patterns (by 90-day reference periods)

KYLEENAFirst 90 days
N=1566
End of year 1
N=1371
End of year 5
N=530
Amenorrhea*<1%12%23%
Infrequent bleeding10%26%26%
Frequent bleeding25%4%2%
Prolonged bleeding§57%6%1%
Irregular bleeding43%17%9%

*Defined as subjects with no bleeding/spotting throughout the 90-day reference period.1

Defined as subjects with 1 or 2 bleeding/spotting episodes in the 90-day reference period.1

Defined as subjects with more than 5 bleeding/spotting episodes in the 90-day reference period.1

§Defined as subjects with bleeding/spotting episodes lasting more than 14 days in the 90-day reference period. Subjects with prolonged bleeding may also be included in one of the other categories (excluding amenorrhea).1

llDefined as subjects with 3 to 5 bleeding/spotting episodes and less than 3 bleeding/spotting-free intervals of 14 or more days.1

Cycles become more consistent over time1

Minimal fluctuations in bleeding and spotting after first 6 months.
 

  • Bleeding: Mean number of days overall did not fluctuate more than 1.3 days per 28-day cycle
  • Spotting: Mean number of days overall did not fluctuate more than 1.4 days per 28-day cycle

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