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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early cycle insertion | Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle. |
| |
| Late cycle insertion | Participants in this group have the intrauterine system inserted during the remainder of their cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrauterine system | Device | Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding and spotting as collected by daily texts | Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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Women presenting for intrauterine device insertion.
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| Name | Affiliation | Role |
|---|---|---|
| Noa'a Shimoni, MD MPH | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood | Morristown | New Jersey | 07960 | United States | ||
| NJFPC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30831104 | Derived | Shimoni N, Choudhury T, Goldman AR, Frondelli M, Chen PH. Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing. Contraception. 2019 Jun;99(6):340-344. doi: 10.1016/j.contraception.2019.02.004. Epub 2019 Mar 1. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 5, 2020 | |
| Reset | Oct 26, 2020 | |
| Release | Apr 24, 2026 | |
| Reset | May 15, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 5, 2020 | Oct 26, 2020 | |||
| Apr 24, 2026 |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007434 | Intrauterine Devices |
| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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|
| Newark |
| New Jersey |
| 07103 |
| United States |
| SHS | Newark | New Jersey | 07103 | United States |
| May 15, 2026 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |