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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR CYTOTEC


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All Clinical Trials for Cytotec

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00120042 ↗ Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption Completed The University of Western Australia N/A 2005-02-01 Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness. This process is usually conducted medically in Australia, using the prostaglandin E1 analogue misoprostol. This prostaglandin, although not specifically licensed for use in pregnancy termination, is now a common abortifacient with a lot of accumulated experience both within Australia and internationally. Since 1996, misoprostol, a synthetic prostaglandin, has been used at King Edward Memorial Hospital as the principal agent for second trimester pregnancy termination. This agent is administered vaginally, and in its current form and dosage regimen results in 75-80% of women delivering within 24 hours. As experience with this agent has grown, it has been observed that in approximately 40% of women the placenta is either completely retained or incompletely delivered, necessitating operative removal and an increased potential for maternal blood loss. In this study, it is planned, in a randomized controlled clinical trial, to evaluate three regimens for the management of placental delivery in women undergoing second trimester pregnancy interruption. The primary intention of this study is to develop a third stage management protocol to reduce the incidence of placental retention in second trimester medical pregnancy termination. The secondary aim of this study is to assess the ultrasound appearance of the uterus and its cavity within 24 hours of second trimester pregnancy termination. The ultrasound appearances of the uterus following second trimester pregnancy loss have not been previously investigated in detail. Previous ultrasound studies of the term postpartum uterus have demonstrated a high incidence of echogenic material within the uterine cavity soon after an uncomplicated vaginal delivery. These findings have been of concern as the ultrasound appearances may erroneously imply a need for operative intervention. The investigators wish to ascertain if this high incidence of echogenic tissue presence is also true in the second trimester. Ultrasound is frequently used by clinicians to define placental completeness and the potential requirement for surgical curettage. The data from this single sonographic examination of the uterus will provide baseline data for a planned longitudinal study of uterine appearances following second trimester pregnancy loss and their correlation with clinical symptoms.
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.
NCT00141895 ↗ A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death Terminated American University of Beirut Medical Center Phase 3 2004-09-01 Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance to effect the medical termination of pregnancy in the second trimester, either alone or after pretreatment with mifepristone. The primary reasons for this prompt incorporation into standard practice include its low cost and the lack of stringent storage requirements. Vaginal administration seems to be more efficacious than when given orally. The use of sublingual misoprostol for first trimester abortions has been extensively investigated as evidenced by the large number of publications comparing sublingual to other routes of misoprostol for first trimester pregnancy termination, on the assumption that the sublingual route would have a similar efficacy of the vaginal route. 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 second trimester termination following intrauterine fetal death. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
NCT00200226 ↗ Oral Misoprostol Before Endometrial Biopsy Completed Memorial University of Newfoundland Phase 3 2003-02-01 An endometrial biopsy involves a thin tube being passed through the cervix (opening of the uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort with this procedure especially if the cervix is not dilated or opened. Previous research has suggested that taking a drug called misoprostol may help the cervix to start to dilate or open. This study will see if misoprostol will help open the cervix for an endometrial biopsy, to lessen the discomfort and make the biopsy easier to perform.
NCT00256009 ↗ Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment Unknown status Rigshospitalet, Denmark Phase 4 1969-12-31 A randomize trial: expectation or evacuatio uteri for the treatment after late abortion
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cytotec

Condition Name

Condition Name for Cytotec
Intervention Trials
Postpartum Hemorrhage 6
Labor Induction 5
Pregnancy 5
Induction of Labor 4
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Condition MeSH

Condition MeSH for Cytotec
Intervention Trials
Hemorrhage 22
Postpartum Hemorrhage 12
Leiomyoma 4
Abortion, Incomplete 4
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Clinical Trial Locations for Cytotec

Trials by Country

Trials by Country for Cytotec
Location Trials
United States 49
Egypt 15
Israel 7
Sweden 4
Netherlands 4
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Trials by US State

Trials by US State for Cytotec
Location Trials
California 7
Texas 6
New York 5
Massachusetts 5
Illinois 4
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Clinical Trial Progress for Cytotec

Clinical Trial Phase

Clinical Trial Phase for Cytotec
Clinical Trial Phase Trials
Phase 4 35
Phase 3 19
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Cytotec
Clinical Trial Phase Trials
Completed 57
Unknown status 18
Terminated 11
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Clinical Trial Sponsors for Cytotec

Sponsor Name

Sponsor Name for Cytotec
Sponsor Trials
Gynuity Health Projects 10
Cairo University 7
Ain Shams University 4
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Sponsor Type

Sponsor Type for Cytotec
Sponsor Trials
Other 140
Industry 4
NIH 1
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Clinical Trials, Market Analysis, and Projections for Cytotec (Misoprostol)

Introduction to Cytotec (Misoprostol)

Cytotec, known generically as misoprostol, is a synthetic prostaglandin E1 analogue used for several medical purposes, including the prevention of NSAID-induced gastric ulcers and the induction of labor or abortion. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Prevention of NSAID-Induced Gastric Ulcers

Clinical trials have shown that misoprostol is effective in reducing the risk of NSAID-induced gastric and duodenal ulcers. In studies involving healthy volunteers, misoprostol doses of 200 mcg four times a day significantly reduced the incidence of gastric ulcers compared to placebo when administered with NSAIDs like tolmetin and naproxen[1].

Abortion and Labor Induction

In the context of abortion, misoprostol is often used in combination with mifepristone. A randomized, double-blind, placebo-controlled trial published in The Lancet demonstrated that the combination of mifepristone and misoprostol was more effective than misoprostol alone in achieving the completion of missed abortion[4].

Safety Profile

Clinical trials have also highlighted the safety profile of misoprostol. While it does not significantly affect various physiological parameters such as serum levels of prolactin, gonadotropins, thyroid-stimulating hormone, and others, it can cause gastrointestinal side effects like diarrhea, which is usually self-limiting but can sometimes lead to severe dehydration[1].

Market Analysis

Global Market Size and Growth

The global market for abortion drugs, which includes misoprostol, is projected to grow significantly. By 2024, the abortion drugs market is expected to reach USD 26.88 billion and is anticipated to grow at a CAGR of 8.5% to reach USD 37.25 billion by 2029[2].

Regional Market Dynamics

North America is currently the largest market for abortion drugs, driven by factors such as the high incidence of unwanted pregnancies and increasing research and development activities. The Asia Pacific region is expected to be the fastest-growing market due to rising awareness and acceptance of abortion drugs[2].

Key Players

Major companies operating in the abortion drugs market include Pfizer Inc., Dr. Reddy’s Laboratories Ltd, Corcept Therapeutics Incorporated, GenBioPro, and EVER Pharma. These companies are driving innovation and commercial availability, which in turn is boosting market growth[2].

Market Projections

Growth Drivers

The growth of the misoprostol market is driven by several factors:

  • Increasing Unintended Pregnancies: The rising number of unplanned pregnancies, particularly in regions like North America, is a significant driver. For instance, around 50% of pregnancies in Canada are unplanned[2].
  • Research and Development: Ongoing clinical trials and research funding for women’s health are expected to enhance the development of advanced abortion medicines. For example, the National Institutes of Health in the U.S. increased its funding for women’s health research from $4.587 billion in 2023 to $5.049 billion in 2024[2].
  • Government Legislation: Supportive government legislation and growing funding for women’s health research are also contributing to market growth[2].

Market Segmentation

The misoprostol market can be segmented based on type and application. The report by Cognitive Market Research provides an in-depth analysis of these segments, highlighting the fastest-growing segments and their expected growth rates[5].

Challenges and Restraints

Side Effects and Safety Concerns

While misoprostol is generally safe, it can cause significant side effects such as diarrhea, which can sometimes lead to severe dehydration. Patients with underlying conditions like inflammatory bowel disease need careful monitoring[1].

Regulatory and Ethical Considerations

The use of misoprostol for abortion is subject to stringent regulations and ethical considerations. Variations in legal frameworks across different countries can impact market growth and accessibility[2].

Key Takeaways

  • Clinical Efficacy: Misoprostol is effective in preventing NSAID-induced gastric ulcers and in combination with mifepristone for abortion.
  • Market Growth: The global abortion drugs market, including misoprostol, is expected to grow significantly, driven by increasing unintended pregnancies and research activities.
  • Regional Dynamics: North America is the largest market, while the Asia Pacific region is expected to be the fastest-growing.
  • Challenges: Side effects and regulatory considerations are key challenges that need to be addressed.

FAQs

What is the current market size of the abortion drugs market, which includes misoprostol?

The abortion drugs market size is expected to reach USD 26.88 billion in 2024[2].

Which region is expected to be the fastest-growing market for abortion drugs?

The Asia Pacific region is estimated to grow at the highest CAGR over the forecast period (2024-2029)[2].

What are the primary drivers of the misoprostol market growth?

The primary drivers include increasing unintended pregnancies, growing research and development activities, and supportive government legislation[2].

Who are the major players in the abortion drugs market?

Major players include Pfizer Inc., Dr. Reddy’s Laboratories Ltd, Corcept Therapeutics Incorporated, GenBioPro, and EVER Pharma[2].

What are the common side effects of misoprostol?

Common side effects include diarrhea, which can sometimes lead to severe dehydration, and other gastrointestinal issues[1].

Sources

  1. Cytotec® Label - FDA.
  2. Abortion Drugs Market Size & Share Analysis - Mordor Intelligence.
  3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace.
  4. A randomised, double-blind, placebo-controlled trial - The Lancet.
  5. Misoprostol Market Report 2024 (Global Edition) - Cognitive Market Research.

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