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™).
NCT01962831 ↗	Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter	Completed	Regina Qu'Appelle Health Region	N/A	2013-10-01	The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.
NCT01962831 ↗	Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter	Completed	Saskatchewan Health Authority - Regina Area	N/A	2013-10-01	The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.

Clinical Trial Conditions for Cervidil

Condition Name

Condition Name for Cervidil
Intervention	Trials
Cervical Ripening	2
Labor Induction	2
Labor, Induced	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
Utah	2
New York	2
Arizona	2
Wisconsin	1
Washington	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
Weill Medical College of Cornell University	1
Mednax Center for Research, Education and Quality	1

Sponsor Type

Sponsor Type for Cervidil
Sponsor	Trials
Other	7
Industry	2

Clinical Trials, Market Analysis, and Projections for CERVIDIL

Introduction to CERVIDIL

CERVIDIL, a vaginal insert containing 10 mg of dinoprostone (a form of prostaglandin E2), is indicated for the initiation and/or continuation of cervical ripening in patients at or near term who have a medical or obstetrical indication for the induction of labor. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

CERVIDIL has been evaluated in several clinical trials to assess its efficacy and safety.

Study Design and Outcomes

• The drug was studied in three randomized, double-blind, placebo-controlled clinical trials involving 658 women, with 320 receiving active therapy. These studies included the vaginal pessary alone (Studies 101-003 and 101-103) and the vaginal pessary inserted into a knitted polyester retrieval system (Study 101-801)[1][4].
• The trials defined treatment success as a Bishop score increase of ≥3 at 12 hours, vaginal delivery within 12 hours, or a Bishop score of ≥6 at 12 hours. CERVIDIL successfully ripened the cervix in the majority of patients, with treatment success rates ranging from 65% to 72% compared to 24% to 48% in the placebo groups[1][4].

Time to Delivery and Onset of Labor

• CERVIDIL significantly reduced the median time to delivery and the median time to the onset of labor. For example, in Study 101-801, the average time to delivery was 31.1 hours for the CERVIDIL group versus 51.8 hours for the placebo group[1][4].

Safety and Adverse Events

• While CERVIDIL is generally well-tolerated, adverse events such as uterine hyperstimulation with or without fetal distress, and fetal distress without uterine hyperstimulation were reported. These events were more common in the CERVIDIL group than in the placebo group[1][4].

Market Analysis

Current Market Position

• CERVIDIL is a well-established product in the obstetric care market, particularly for cervical ripening and labor induction. Its efficacy and safety profile have made it a preferred choice among healthcare providers.

Market Trends

• The obstetric care market is influenced by advancements in medical technology and changing patient needs. The trend towards more personalized and effective treatments is likely to continue, with CERVIDIL remaining a key player due to its proven track record[5].

Competitive Landscape

• The market for labor induction and cervical ripening agents is relatively niche but competitive. CERVIDIL competes with other prostaglandin-based products and other methods of labor induction. However, its unique delivery system and established efficacy make it a strong contender in this space.

Future Projections

Market Growth

• The demand for effective labor induction and cervical ripening agents is expected to grow, driven by increasing birth rates in some regions and the need for safe and efficient obstetric care. CERVIDIL is likely to benefit from this trend, maintaining its market share and potentially expanding into new markets[5].

Regulatory and Clinical Developments

• There are no immediate plans for significant changes or new clinical trials specifically for CERVIDIL. However, ongoing research in obstetric care and labor induction may lead to new guidelines or recommendations that could impact the use of CERVIDIL and similar products.

Economic Factors

• The life sciences industry is facing challenges such as pricing and access to drugs, as well as the impact of generic drugs and biosimilars. However, CERVIDIL's established position and lack of direct generic competition in its specific use case mean it is less likely to be immediately affected by these trends[5].

Key Takeaways

• Efficacy: CERVIDIL has demonstrated significant efficacy in cervical ripening and reducing the time to delivery and onset of labor.
• Safety: While generally well-tolerated, CERVIDIL can cause adverse events such as uterine hyperstimulation and fetal distress.
• Market Position: CERVIDIL is a leading product in the obstetric care market for labor induction and cervical ripening.
• Future Projections: The market demand for CERVIDIL is expected to grow, driven by increasing needs in obstetric care, although it will need to navigate broader industry trends such as pricing and access challenges.

FAQs

What is CERVIDIL used for?

CERVIDIL is used for the initiation and/or continuation of cervical ripening in patients at or near term who have a medical or obstetrical indication for the induction of labor.

How effective is CERVIDIL in clinical trials?

CERVIDIL has shown high efficacy in clinical trials, with treatment success rates ranging from 65% to 72% compared to 24% to 48% in the placebo groups.

What are the common adverse events associated with CERVIDIL?

Common adverse events include uterine hyperstimulation with or without fetal distress, and fetal distress without uterine hyperstimulation.

How does CERVIDIL compare to other labor induction methods?

CERVIDIL's unique delivery system and established efficacy make it a strong contender in the market for labor induction and cervical ripening agents.

What are the future market projections for CERVIDIL?

The demand for CERVIDIL is expected to grow, driven by increasing needs in obstetric care, although it will need to navigate broader industry trends such as pricing and access challenges.

Sources

1. Ferring Pharmaceuticals: Efficacy - CERVIDIL.
2. DelveInsight: The Evolving Spectrum of Cervical Cancer Treatments.
3. Merck: Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL 9.
4. FDA: CERVIDIL - accessdata.fda.gov.
5. Deloitte Insights: 2025 life sciences outlook.