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
Some patients experienced amenorrhea and infrequent bleeding over 5 years1
Bleeding patterns (by 90-day reference periods)
| KYLEENA | First 90 days N=1566 | End of year 1 N=1371 | End of year 5 N=530 |
|---|---|---|---|
| Amenorrhea* | <1% | 12% | 23% |
| Infrequent bleeding† | 10% | 26% | 26% |
| Frequent bleeding‡ | 25% | 4% | 2% |
| Prolonged bleeding§ | 57% | 6% | 1% |
| Irregular bleeding‖ | 43% | 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
