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| Name | Class |
|---|---|
| Cuidado Integral de la Mujer, Gineclinic, S.C. | UNKNOWN |
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This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.
Missed period pills (MPPs) are medications used for uterine evacuation among women with late menses who have not confirmed pregnancy status. Provision of MPPs could expand reproductive service options for individuals in a variety of settings. This study will collect data on the efficacy, safety, and acceptability of a 3-day missed period pill regimen among individuals with missed menses of 1-10 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Missed period pill regimen | Experimental | 1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel | Drug | All participants receive 1.5 mg levonorgestrel on day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of missed period pill regimen | Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment | Up to 28 days after administration of levonorgestrel |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of missed period pill regimen | Proportion of all enrolled participants not pregnant at follow-up (among those who were and were not pregnant at enrollment) | Up to 28 days after administration of levonorgestrel |
| Effectiveness at inducing return of menses within 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holly A Anger | Contact | 2124481230 | hanger@gynuity.org | |
| Manuel Bousieguez | Contact | 2124481230 | mbousieguez@gynuity.org |
| Name | Affiliation | Role |
|---|---|---|
| Beverly H Winikoff, MD | Gynuity Health Projects | Principal Investigator |
| Holly A Anger | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cuidado Integral de la Mujer, Gineclinic, S.C | Recruiting | Mexico City | Mexico |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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Simon's two-stage design
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| Mifepristone |
| Drug |
All participants receive 200 mg mifepristone on day 3 |
|
Proportion of participants reporting return of missed menses within 10 days of initiating missed period pill regimen |
| Up to 10 days after administration of levonorgestrel |
| Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability) | Proportion of participants who report adverse events and/or side effects | Up to 28 days after administration of levonorgestrel |
| Acceptability of missed period pills | Proportion of participants who report that the missed period pill service was acceptable or highly acceptable to them | Up to 28 days after administration of levonorgestrel |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004963 | Estrenes |
| D004962 | Estranes |