CERVIDIL (dinoprostone)
Cervidil helps patients with the cervical ripening process when they are at or near the end of their pregnancy. It is used for women who require labor induction for medical or obstetrical reasons. This medication prepares the cervix for delivery by changing its consistency and encouraging dilatation and effacement.
How CERVIDIL Works
This medication works by mimicking a natural local hormone that triggers the final events leading to labor. It stimulates the production of prostaglandin F 2α, which sensitizes the uterine muscles to oxytocin and promotes changes in the cervix like softening and opening.
Details
- Status
- Prescription
- First Approved
- 1995-03-30
- Routes
- VAGINAL
- Dosage Forms
- INSERT, EXTENDED RELEASE
CERVIDIL Approval History
What CERVIDIL Treats
2 indicationsCERVIDIL is approved for 2 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cervical ripening in pregnant women at or near term
- Induction of labor for medical or obstetrical reasons
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02888041 RE-DINO | I15014 (RE-DINO) | Ph 3 | terminated | Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term? |
| NCT05761418 | REC-H-PhBSU-22021 | Ph 3 | completed | Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy |
| NCT03001661 SOLVE | Solve | Ph 3 | completed | An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt |
| NCT03067597 | 000261 | Ph 3 | completed | An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term |
| NCT03067727 | 000262 | Ph 3 | completed | A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term |
| NCT04044079 | dinoprostone misoprostol | Ph 4 | completed | Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients |
| NCT04079140 | vaginal dinoprostone IUD | Ph 4 | completed | Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion |
| NCT04080336 | dinoprostone misoprostol IUD | Ph 4 | completed | Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women |
| NCT04046302 | dinoprostone IUD pain | Ph 4 | completed | Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women. |
| NCT04045548 | dinoprostone IUD | Ph 4 | completed | Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery |
| NCT03320187 | OG MS27042017 | Ph 2, Ph 3 | completed | Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial |
| NCT01765881 CYTOPRO | 1014301 2011-000933-35 | Ph 2 | completed | Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2 |
| NCT01190163 SOFTNES | FE999901 CS01 | Ph 4 | terminated | Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CERVIDIL FDA Label Details
Indications & Usage
FDA Label (PDF)CERVIDIL is indicated for the treatment of Cervical ripening in pregnant women at or near term; Induction of labor for medical or obstetrical reasons.
Track CERVIDIL with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.