Drugs / Misoprostol
Misoprostol
DrugMisoprostol is a prostaglandin analog medicine used for ulcer prevention and multiple obstetric/gynecologic indications, including abortion regimens and postpartum bleeding contexts. In U.S. products it is marketed as Cytotec and in combinations such as Arthrotec. It is available as an established prescription medicine.
- Trials
- 400
- Recruiting
- 13
- Completed
- 245
- With results
- 49
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Unknown | Total |
|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 2 | — | — | 4 | — | 1 | 3 | 10 |
| Phase 1 | 1 | 1 | — | 9 | — | 1 | 1 | 13 |
| Phase 1/2 | — | 1 | — | 1 | — | — | 2 | 4 |
| Phase 2 | — | — | — | 23 | 2 | 1 | 14 | 40 |
| Phase 2/3 | — | 1 | — | 16 | 1 | — | 4 | 22 |
| Phase 3 | — | 2 | — | 39 | 5 | 2 | 9 | 57 |
| Phase 4 | 4 | 1 | — | 67 | 11 | 2 | 24 | 109 |
| Not applicable | 5 | 1 | 3 | 79 | 8 | 3 | 31 | 130 |
| Unknown | 1 | — | — | 7 | 1 | — | 6 | 15 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Postpartum Hemorrhage | — | 2 | 1 | 7 | 3 | 8 | 15 | 26 | — | 62 |
| Abortion, Spontaneous | — | — | — | 3 | 4 | 2 | 3 | 8 | — | 20 |
| Hemorrhage | — | — | — | 2 | 1 | 5 | 8 | 2 | — | 18 |
| Abortion, Missed | 1 | 2 | — | 4 | 1 | — | 6 | 2 | 1 | 17 |
| Abortion, Incomplete | — | 1 | — | — | — | 1 | 2 | 6 | — | 10 |
| Blood Loss, Surgical | — | — | — | — | — | 3 | 3 | 1 | 1 | 8 |
| Dilatation, Pathologic | 1 | — | — | — | — | 2 | 1 | 4 | — | 8 |
| Fetal Membranes, Premature Rupture | — | — | 1 | — | — | — | 4 | 3 | — | 8 |
| Pre-Eclampsia | — | — | 1 | — | — | 2 | 1 | 1 | 1 | 6 |
| Myofibroma | — | — | — | — | — | 4 | — | — | 1 | 5 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Gynuity Health Projects | 50 | 7 |
| 2 | Cairo University | 29 | 6 |
| 3 | Ain Shams University | 25 | 16 |
| 4 | Assiut University | 14 | 2 |
| 5 | Aswan University Hospital | 13 | 0 |
| 6 | Ain Shams Maternity Hospital | 8 | 0 |
| 7 | Stanford University | 6 | 2 |
| 8 | Montefiore Medical Center | 5 | 0 |
| 9 | University of Pennsylvania | 5 | 2 |
| 10 | Aljazeera Hospital | 4 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Misoprostol | 400 |
| 2 | Mifepristone | 52 |
| 3 | Oxytocin | 47 |
| 4 | Dinoprostone | 19 |
| 5 | carbetocin | 16 |
| 6 | Tranexamic Acid | 11 |
| 7 | isosorbide-5-mononitrate | 9 |
| 8 | Letrozole | 9 |
| 9 | Alprostadil | 6 |
| 10 | Vitamin B 6 | 4 |
Evidence
- Results reported
- 20%49 of 245 completed
- Published
- 10.2%25 of 245 completed
- Primary endpoint met
- 35.5%11 of 31 analyses
- Median months to report
- 15
Documents disclosed
Trial profile
- Median enrollment
- 148
- Median duration
- 16.9months
- Countries
- 66
- Study sites
- 487
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 155
- Phase 1
- 90
- Phase 1/2
- 80
- Phase 2
- 120
- Phase 2/3
- 200
- Phase 3
- 170
- Phase 4
- 150
- Not applicable
- 150
- Unknown
- 118
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Cairo | Egypt | 67 |
| 2 | Aswān | Egypt | 14 |
| 3 | Asyut | Egypt | 10 |
| 4 | Boston | United States | 9 |
| 5 | Chicago | United States | 7 |
| 6 | Giza | Egypt | 7 |
| 7 | Ho Chi Minh City | Vietnam | 7 |
| 8 | The Bronx | United States | 7 |
| 9 | Ankara | Turkey (Türkiye) | 6 |
| 10 | Philadelphia | United States | 6 |
Terminations
- Terminated
- 28
- Withdrawn
- 10
- Stopped for recruitment
- 3.5%14 of 400 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT04940013 Terminated | Terminated | Lack of successful recruitment and loss of funding | 2025-09-01 |
| NCT03796416 Withdrawn | Withdrawn | in error | 2025-07-31 |
| NCT06078501 Terminated | Terminated | Recruitment not feasible for this patient population within study timeframe | 2024-07-12 |
| NCT03866772 Terminated | Terminated | RECRUTIMENT DIFICULTIES | 2023-09-24 |
| NCT04768010 Withdrawn | Withdrawn | After significant delays study was never initiated. No participants enrolled | 2023-09-18 |
| NCT05119439 Terminated | Terminated | Enrollment | 2023-06-30 |
| NCT03435458 Terminated | Terminated | interim analyses | 2023-02-02 |
| NCT02209545 Terminated | Terminated | The study was prematurely closed due to low enrollment rates. | 2022-07-31 |
| NCT04004845 Terminated | Terminated | Study was temporarily paused due to COVID19 and ultimately terminated at the discretion of the PI | 2022-06-01 |
| NCT03617172 Terminated | Terminated | Low enrollment | 2021-09-22 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: