CLINICAL TRIALS PROFILE FOR CERVIDIL

All Clinical Trials for CERVIDIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00140114 ↗	Sublingual Versus Vaginal Misoprostol for Labor Induction at Term	Completed	American University of Beirut Medical Center	Phase 3	2004-01-01	Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. In contradistinction to prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive and available in scored tablets that can be broken and inserted vaginally. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance as both a labor induction and a cervical ripening agent. Such off-label indication has been endorsed by the American College of Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its use. Vaginal administration seems to be more efficacious than when given orally, although there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg. The use of sublingual misoprostol for cervical ripening at term was recently investigated in two studies that compared it to the oral route, on the assumption that the sublingual route would have the higher efficacy of the vaginal route by avoiding the first pass effects of the gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding the direct effects on the cervix. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the induction of labor at term. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
NCT00308711 ↗	Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor	Completed	Ferring Pharmaceuticals	Phase 3	2006-04-01	The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
NCT00504465 ↗	Combined Agent Randomized Trial of Induction of Labor	Completed	Weill Medical College of Cornell University	N/A	2002-05-01	To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.
NCT01402050 ↗	Foley Catheter Versus Cervidil for Induction of Labor at Term	Completed	Mednax Center for Research, Education and Quality	N/A	2010-06-01	OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction. HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).
NCT01402050 ↗	Foley Catheter Versus Cervidil for Induction of Labor at Term	Completed	Mednax Center for Research, Education, Quality and Safety	N/A	2010-06-01	OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction. HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).

Clinical Trial Conditions for CERVIDIL

Condition Name

Condition Name for CERVIDIL
Intervention	Trials
Labor Induction	2
Labor, Induced	2
Cervical Ripening	2
Induction of Labor	1

Condition MeSH

Condition MeSH for CERVIDIL
Intervention	Trials
Obesity	1

Clinical Trial Locations for CERVIDIL

Trials by Country

Trials by Country for CERVIDIL
Location	Trials
United States	26
Canada	4
Lebanon	1

Trials by US State

Trials by US State for CERVIDIL
Location	Trials
Arizona	2
Utah	2
New York	2
Minnesota	1
Michigan	1

Clinical Trial Progress for CERVIDIL

Clinical Trial Phase

Clinical Trial Phase for CERVIDIL
Clinical Trial Phase	Trials
Phase 3	3
N/A	3

Clinical Trial Status

Clinical Trial Status for CERVIDIL
Clinical Trial Phase	Trials
Completed	5
Terminated	1

Clinical Trial Sponsors for CERVIDIL

Sponsor Name

Sponsor Name for CERVIDIL
Sponsor	Trials
Ferring Pharmaceuticals	2
American University of Beirut Medical Center	1
Weill Medical College of Cornell University	1

Sponsor Type

Sponsor Type for CERVIDIL
Sponsor	Trials
Other	7
Industry	2

CERVIDIL (dinoprostone) Clinical Trials Update and Market Outlook

Last updated: May 6, 2026

What is CERVIDIL and how is it positioned in the market?

CERVIDIL is the brand name for dinoprostone (prostaglandin E2, PGE2) delivered via a vaginal insert used to promote cervical ripening and induction of labor. It is an established, standard-of-care product in obstetrics, with market dynamics driven by:

• Delivery of labor induction services (hospital admissions and patient volumes)
• Choice of induction modality (PGE2 inserts versus other PGE2 formulations and oxytocin protocols)
• Safety, workflow, and dosing/monitoring practices at provider level

No new molecular entity information changes CERVIDIL’s IP posture in the way a novel drug would; the relevant competitive set is mainly other dinoprostone products and misoprostol (off-label or brand depending on geography), plus mechanical cervical ripening devices.

Clinical trials update: what is the current evidence direction?

CERVIDIL’s clinical evidence base is largely mature. Recent activity is typically characterized by:

• Comparative trials evaluating dinoprostone delivery methods versus alternative PGE2 regimens (tablets, gels), oxytocin, and mechanical ripening devices
• Subgroup studies tied to induction outcomes (time to delivery, rates of cesarean delivery, uterine tachysystole, neonatal outcomes)
• Real-world evidence and protocol updates driven by obstetric guideline evolution rather than by new dinoprostone pharmacology

A complete “latest trials update” requires a current, verifiable registry snapshot (e.g., ongoing/recent interventional studies and results publications by date). That dataset is not provided here, and a partial update without the underlying trial list would risk factual gaps.

What is the competitive landscape for labor induction in which CERVIDIL competes?

CERVIDIL competes in a care pathway where the decision is usually made between:

• PGE2 options: dinoprostone formulations (insert, gel, tablet depending on market)
• Misoprostol: often used for cervical ripening and induction (some markets have specific approvals; elsewhere it is widely used off-label)
• Mechanical methods: balloon catheters and other mechanical cervical ripening approaches
• Oxytocin protocols: induction or augmentation after initial cervical ripening

Market share tends to shift based on:

• Provider preference and institutional protocol
• Clinical outcomes and safety monitoring comfort
• Procurement and tender pricing
• Supply reliability and distribution

How does demand for labor induction drive CERVIDIL volumes?

CERVIDIL demand is a function of obstetric induction rates. Key volume drivers:

• Overall births in treated jurisdictions
• Induction adoption rates by gestational age and maternal/fetal indications
• Hospital induction capacity and scheduling
• Guideline adherence that increasingly standardizes when and how induction should occur

For forecasting, the most material assumption is not “dinoprostone efficacy,” because that is already established; it is whether induction volumes rise or fall and how quickly protocols switch between available modalities.

Market analysis: what matters for pricing and retention?

Price and share retention for established branded obstetric drugs typically depend on:

• Generic/therapeutic competition (dinoprostone formulations, including lower-cost alternatives where available)
• Reimbursement behavior (hospital billing and pharmacy reimbursement structures)
• Procurement cycles and contracting pressure in hospital networks
• Stock management practices (reduced stockouts protect continuity of use)

Where alternative modalities gain adoption, share can decline even if CERVIDIL remains clinically used.

Forecast model: what direction does the market likely take?

A credible projection requires current market size, installed base, and ongoing competitors’ pricing actions, none of which are included in the input. Without these inputs, any numerical forecast would be fabricated.

That said, directional drivers are clear for this category:

• If induction rates increase, demand generally rises for whatever modalities providers favor.
• If protocols shift toward mechanical methods or misoprostol, CERVIDIL’s unit share can erode even when overall induction volumes grow.
• If dinoprostone insert workflow and safety fit local practice, CERVIDIL can maintain stable share.

Key strategic implication for investors or R&D buyers

For CERVIDIL specifically, investment returns are more likely to be influenced by:

• Contracting and payer/hospital formularies
• Competitive substitution (especially within PGE2 alternatives and misoprostol-based pathways)
• Supply chain reliability

The category is mature; differentiation is less about proving PGE2 pharmacology and more about operational outcomes and protocol fit.

Key Takeaways

• CERVIDIL is a mature dinoprostone (PGE2) cervical ripening and labor induction product with clinical evidence that is already established.
• Market dynamics are driven by induction volumes, hospital protocol selection, and competitive modality switching (other dinoprostone formulations, misoprostol, mechanical methods).
• A numerical market projection and a “latest clinical trials update” require current registry-level and market-sizing inputs. Those inputs are not present in the provided material.
• For business decisions, the highest-leverage levers are hospital contracting/formulary status and protocol substitution risk, not breakthrough clinical efficacy claims.

FAQs

1. What indications does CERVIDIL cover?
   Cervical ripening and induction of labor in appropriate obstetric settings.

2. What are CERVIDIL’s closest competitive alternatives?
   Other dinoprostone formulations, misoprostol regimens, mechanical cervical ripening devices, and oxytocin protocols.

3. What most influences CERVIDIL demand?
   Induction adoption rates and hospital protocol preferences across the jurisdictions where it is used.

4. Is CERVIDIL a high innovation product class?
   It is in a mature pharmacology category where differentiation often comes from delivery method performance and clinical workflow fit.

5. What risks matter most for CERVIDIL market share?
   Substitution to other induction modalities, procurement pricing pressure, and supply continuity.

References

[1] FDA. CERVIDIL prescribing information.
[2] DailyMed. CERVIDIL (dinoprostone) insert prescribing information.
[3] ClinicalTrials.gov. Study records for dinoprostone and labor induction/cervical ripening (search results).