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This study will assess the acceptability and use of medical menstrual regulation among women in the United States.
Medical menstrual regulation (MMR) entails the use of uterine evacuation medications by women with late menses without confirming pregnancy status. Provision of MMR in the United States could expand reproductive choice and service options for women. This study will collect data on the acceptability, efficacy, safety and feasibility of MMR among women with missed menses of 1-21 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical menstrual regulation | Experimental | Mifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | All participants will receive 200 mg mifepristone, to be taken orally on day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who report that MMR was acceptable or highly acceptable during the exit interview | Acceptability of MMR | Up to 28 days after mifepristone administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants not pregnant at follow-up | Efficacy | Up to 28 days after mifepristone administration |
| Number of participants with adverse events and/or side effects | Safety and side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy R Sheldon, PhD | Contact | 212-448-1230 | wsheldon@gynuity.org |
| Name | Affiliation | Role |
|---|---|---|
| Wendy R Sheldon, PhD | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carafem Health Center | Not yet recruiting | Skokie | Illinois | 60076 | United States |
Sharing de-identified data will be considered upon individual request.
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Misoprostol | Drug | All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2) |
|
| Up to 28 days after mifepristone administration |
| Perceived advantages and disadvantages of MMR as reported by participants during the exit interview | Experiences, perceived advantages and disadvantages | Up to 28 days after mifepristone administration |
| Carafem Health Center | Recruiting | Chevy Chase | Maryland | 20815 | United States |
|
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |