Trials / Terminated
TerminatedNCT05119439
Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks
An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Gynuity Health Projects · Academic / Other
- Sex
- Female
- Age
- 11 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mifepristone + 2 doses of misoprostol 800 mcg | Will use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants. |
Timeline
- Start date
- 2022-10-07
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2021-11-15
- Last updated
- 2023-07-25
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05119439. Inclusion in this directory is not an endorsement.