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NCT04063904
Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Phase 4 trial testing Mifepristone in Second Trimester Abortion in 16 participants. Terminated before completion.
3 April 2020
Quick facts
| Lead sponsor | Gynuity Health Projects |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 16 October 2019 |
| Primary completion | 3 April 2020 |
| Estimated completion | 3 April 2021 |
| Sites | 1 location across Colombia |
Drugs / interventions tested
- Mifepristone (MIFEPRISTONE) — full drug profile →
- Misoprostol (Misoprostol) — full drug profile →
Conditions studied
- Second Trimester Abortion — all drugs for Second Trimester Abortion →
Sponsor
Gynuity Health Projects — full company profile →
Who can join
18 and older, female only, with Second Trimester Abortion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D\&E will be performed to complete the abortion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04063904
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mifepristone
Trials testing the same drug.
- NCT06733727 — Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage · NA · not yet recruiting
- NCT06492889 — Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens · Phase 2, PHASE3 · not yet recruiting
- NCT05177510 — Mifepristone Outpatient Labour Induction · Phase 2 · recruiting
- NCT05322252 — Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester · Phase 4 · completed
- NCT05097326 — Mifepristone for Labor Induction · Phase 3 · completed
Other recruiting trials for Second Trimester Abortion
Currently open trials in the same condition.
- NCT06123026 — Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion · Phase 4 · recruiting
Other Gynuity Health Projects trials
Trials by the same sponsor.
- NCT06492889 — Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens · Phase 2, PHASE3 · not yet recruiting
- NCT05781061 — MA-ASAP at Independent Abortion Clinics: A Demonstration Project · NA · completed
- NCT05119439 — Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks · Phase 4 · terminated
- NCT05459142 — Telemedicine Medical Abortion Service Using the "No-test" Protocol in Azerbaijan. · completed
- NCT05278780 — Medication Abortion With Autonomous Self-Assessment Project · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04063904 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gynuity Health Projects
- Last refreshed: 23 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04063904.
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