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| Name | Class |
|---|---|
| William and Flora Hewlett Foundation | OTHER |
| University of Colorado, Denver | OTHER |
| Planned Parenthood Federation of America | OTHER |
| University of Rochester |
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The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse.
While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
Unintended pregnancy rates in the United States are among the highest of developed nations. These high rates can largely be attributed to incorrect or under contraception of women. One focus of decreasing unintended pregnancy and abortion rates has centered on expanding access to and use of long acting reversible contraceptive (LARC) methods which include intrauterine devices (IUDs) and subdermal implants. Emergency contraception, or post-coital contraception, offers significant reductions in the chance of pregnancy following an act of unprotected or under-protected vaginal intercourse. The most common methods of emergency contraception used in the United States are the oral levonorgestrel regimen and oral ulipristal acetate (Ella) regimen which reduce pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine device (Copper IUD). The IUD has the added benefit of providing extended contraceptive use beyond the single episode of unprotected intercourse. The Cu-T380 has been associated with heavier and more crampy menses however, likely dissuading women from use. Among all IUD users, the levonorgestrel intrauterine system (LNG-IUS) has gained popularity over the Cu-T380, perhaps because it offers the potential to improve menstrual related symptoms. There is no data however on the efficacy of the LNG-IUS as a form of emergency contraception. The purpose of this study is to evaluate the efficacy of the LNG-IUS as a method of emergency contraception. Participants will be randomized to receive either the most common method, oral emergency contraception, or the LNG-IUS. Participants will then be evaluated 5-6 weeks following method allocation for pregnancy. Lastly, participants will be asked to complete a telephone surveys at 6 and 12 months following method allocation assessing their use of a consistent contraceptive method, their satisfaction with their contraceptive method, any use of emergency contraception since their enrollment in the study, and lastly any unintended pregnancies experienced since enrollment in the study. If we could show that the LNG-IUS is as effective as the most commonly prescribed method of emergency contraception, we would be introducing another opportunity for LARC initiation and subsequently impacting unintended pregnancy and abortion rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levonorgestrel Intrauterine System | Experimental | Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following. |
|
| Ulipristal acetate | Active Comparator | Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal acetate | Drug | 30 mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pregnancy Following Emergency Contraception | Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group. | 5 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Using Any LARC Method at 6 Months Post Randomization | The number of participants who reported using any type of long acting reversible contraception (LARC) use at 6 months following method allocation will be evaluated, whether or not it was their allocated LNG-IUS. | 6 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen McNicholas, DO, MCSI | Planned Parenthood of the St. Louis Region and Southwest Missouri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Women's Center | Atlanta | Georgia | 30342 | United States | ||
| Indiana University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levonorgestrel Intrauterine System | Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following. levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine |
| FG001 | Ulipristal Acetate | Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception. Ulipristal acetate: 30 mg tablet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We randomized 274 participants in the study, of which 256 completed five-week follow-up, and 235 (85.8%) had complete six month follow-up data. The baseline demographics are based on the 256 participants who were available for analysis after completion of the 5 week follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Levonorgestrel Intrauterine System | Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following. levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Pregnancy Following Emergency Contraception | Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group. | total eligible for analysis after 5-6 weeks post randomization = 256; total eligible for analysis after 6 months post randomization = 235 | Posted | Count of Participants | Participants | 5 weeks post-randomization |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levonorgestrel Intrauterine System | Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following. levonorgestrel IUS: Levonorgestrel IUS, 52mg placed intrauterine |
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Group size limits the precision of our estimate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Planned Parenthood of the St. Louis Region and Southwest Missouri | 314-531-7526 | 384 | research@ppslr.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2014 | Sep 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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| OTHER |
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| levonorgestrel IUS | Device | Levonorgestrel IUS, 52mg placed intrauterine |
|
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| Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS |
Continuation and satisfaction among participants in the LNG-IUS arm who reported still using their LNG-IUS at 6 month post randomization. |
| 6 months post randomization |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63108 | United States |
| Ulipristal Acetate |
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception. Ulipristal acetate: 30 mg tablet |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception. Ulipristal acetate: 30 mg tablet |
|
|
| Secondary | Number of Participants Using Any LARC Method at 6 Months Post Randomization | The number of participants who reported using any type of long acting reversible contraception (LARC) use at 6 months following method allocation will be evaluated, whether or not it was their allocated LNG-IUS. | Posted | Count of Participants | Participants | 6 months post randomization |
|
|
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| Secondary | Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS | Continuation and satisfaction among participants in the LNG-IUS arm who reported still using their LNG-IUS at 6 month post randomization. | 169 = total eligible for analysis from randomized LNG-IUS arm; at 6 months post randomization, 92 of 169 were still using LNG-IUS, so only 92 eligible to analyze satisfaction with LNG-IUS at 6 months post randomization. | Posted | Count of Participants | Participants | 6 months post randomization |
|
|
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| 0 |
| 183 |
| 0 |
| 183 |
| 0 |
| 183 |
| EG001 | Ulipristal Acetate | Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception. Ulipristal acetate: 30 mg tablet | 0 | 73 | 0 | 73 | 0 | 73 |
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