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Last Updated: March 18, 2025

CLINICAL TRIALS PROFILE FOR CETRORELIX ACETATE


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All Clinical Trials for CETRORELIX ACETATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00867659 ↗ The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors Completed Virginia Center for Reproductive Medicine N/A 2009-03-01 This pilot study aims to address whether the prophylactic use of Cetrorelix Acetate after a long gonadotropin-releasing hormone (GnRH) agonist protocol post-hCG (human chorionic gonadotropin) administration can significantly reduce the incidence of OHSS in oocyte donors.
NCT01185704 ↗ Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART) Completed Merck Serono S.A.S, France Phase 3 2008-11-01 This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).
NCT00571870 ↗ Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study Completed Seoul National University Bundang Hospital N/A 2007-11-01 Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's. Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group. Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve better follicular and embryonic development and to improve the pregnancy rates in COH using GnRH antagonist. Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with current protocols, we hypothesized that a shorter duration of GnRH antagonist administration might improve outcome.
NCT00507780 ↗ Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy Withdrawn Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 2007-07-18 This study will examine whether the drug cetrorelex acetate (Cetrotide[Registed Trademark]) can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are known to cause a change in women's periods or to cause menstruation to stop completely, so that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower hormone levels and stop periods in patients undergoing in vitro fertilization treatments. This study will see if making the ovaries inactive may protect them from being affected by certain cancer drugs, and thus preserve fertility. Women up to age 21who have begun menstruating, who have their uterus and at least one functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan, nitrogen mustard or L-phenalanin mustard may be eligible for this study. Participants undergo the following procedures during this 24-month study: Baseline evaluation - Medical history, physical examination and blood and urine tests - Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for future fertility - 3D ultrasound of abdomen - DEXA scan to evaluate bone density Assignment to treatment with: - Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone, or - Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin once a day for six menstrual cycles Evaluations - Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of cetrorelex acetate injections - DEXA scan - after 6 months of cetrorelex acetate injections - Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses - every 3 months during first year, every 6 months during second year - Questionnaire to monitor changes and quality of life - every 3 months during first year, every 6 months during second year.
NCT00298025 ↗ A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation Completed EMD Serono Phase 4 2003-09-01 To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for CETRORELIX ACETATE

Condition Name

82110012345678InfertilityOvarian Hyperstimulation SyndromePreservation of Ovarian FunctionInfertile Women Undergoing Assisted Reproductive Technology (ART)[disabled in preview]
Condition Name for CETRORELIX ACETATE
Intervention Trials
Infertility 8
Ovarian Hyperstimulation Syndrome 2
Preservation of Ovarian Function 1
Infertile Women Undergoing Assisted Reproductive Technology (ART) 1
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Condition MeSH

113320-10123456789101112InfertilitySyndromeOvarian Hyperstimulation SyndromePolycystic Ovary Syndrome[disabled in preview]
Condition MeSH for CETRORELIX ACETATE
Intervention Trials
Infertility 11
Syndrome 3
Ovarian Hyperstimulation Syndrome 3
Polycystic Ovary Syndrome 2
[disabled in preview] 0
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Clinical Trial Locations for CETRORELIX ACETATE

Trials by Country

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Trials by Country for CETRORELIX ACETATE
Location Trials
United States 17
Egypt 3
Iran, Islamic Republic of 2
Italy 2
China 2
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Trials by US State

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Trials by US State for CETRORELIX ACETATE
Location Trials
Colorado 2
Pennsylvania 2
Virginia 2
Maryland 2
Texas 1
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Clinical Trial Progress for CETRORELIX ACETATE

Clinical Trial Phase

57.1%21.4%7.1%14.3%012345678Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for CETRORELIX ACETATE
Clinical Trial Phase Trials
Phase 4 8
Phase 3 3
Phase 2/Phase 3 1
[disabled in preview] 2
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Clinical Trial Status

40.9%22.7%18.2%18.2%03.544.555.566.577.588.599.5CompletedUnknown statusNot yet recruiting[disabled in preview]
Clinical Trial Status for CETRORELIX ACETATE
Clinical Trial Phase Trials
Completed 9
Unknown status 5
Not yet recruiting 4
[disabled in preview] 4
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Clinical Trial Sponsors for CETRORELIX ACETATE

Sponsor Name

trials000111112222Cairo UniversityRoyan InstituteUniversity of Colorado, Denver[disabled in preview]
Sponsor Name for CETRORELIX ACETATE
Sponsor Trials
Cairo University 2
Royan Institute 2
University of Colorado, Denver 2
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Sponsor Type

71.0%22.6%6.5%0-2024681012141618202224OtherIndustryNIH[disabled in preview]
Sponsor Type for CETRORELIX ACETATE
Sponsor Trials
Other 22
Industry 7
NIH 2
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Clinical Trials, Market Analysis, and Projections for Cetrorelix Acetate

Clinical Trials Update

Purpose and Design

Cetrorelix acetate, a gonadotropin-releasing hormone (GnRH) antagonist, is widely used in controlled ovarian stimulation (COS) protocols for women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). A recent clinical trial aims to compare the clinical outcomes of generic cetrorelix acetate versus the reference product in GnRH antagonist protocols[1].

Methodology

The trial involves administering either the generic or the original cetrorelix acetate at a daily dose of 0.25 mg subcutaneously when the lead follicle reaches 14 mm. Oocyte maturation is triggered with 250 mcg of recombinant human chorionic gonadotropin (hCG) when more than two follicles reach 17 mm. The study includes 1,338 participants divided into two patient groups.

Key Findings

Previous clinical studies have established the efficacy and safety of cetrorelix acetate. For instance, Phase II and III clinical trials involving 732 patients demonstrated that cetrorelix acetate effectively inhibits premature luteinizing hormone (LH) surges. The trials showed that both single and multiple dose regimens of cetrorelix acetate are effective, with the 3 mg single dose and 0.25 mg multiple dose regimens being the most commonly used[4].

Safety Profile

Cetrorelix acetate has a favorable safety profile. Preclinical studies revealed no significant cardiovascular, respiratory, or gastrointestinal effects. The most common adverse events observed in clinical trials were local injection site reactions, with no drug-related allergic reactions reported[3][4].

Market Analysis

Global Market Size and Growth

The global cetrorelix acetate market has shown significant growth in recent years. In 2022, the market reached a value of USD XXX million and is expected to grow to USD XXX million by 2029, exhibiting a compound annual growth rate (CAGR) of X.X% during the forecast period[2].

Regional Distribution

The market is segmented by region, with major countries including the United States, Canada, Germany, the UK, France, China, Japan, and others. The Asia Pacific region is expected to be a key driver of growth due to increasing demand for fertility treatments[2].

Competitive Landscape

The market is competitive, with several prominent players holding considerable market shares. The report provides a comprehensive analysis of these players, including their market performance, concentration ratio, and recent developments. This information helps in understanding the competitive situation and gaining insights into competitors[2].

Impact of COVID-19 and Regional Conflicts

The COVID-19 pandemic and regional conflicts, such as the Russia-Ukraine war, have impacted the cetrorelix acetate market. The report details the market scenario during and post-pandemic, including changes in consumer behavior, demand, and supply chain disruptions. These factors have been considered in the market analysis and projections[2].

Market Projections

Forecast Period

The market is forecasted to continue its growth trajectory from 2023 to 2031. The Cetrorelix Acetate API Market, in particular, is expected to experience robust growth rates, driven by increasing demand for fertility treatments and advancements in assisted reproductive technologies[5].

Segmentation

The market is segmented by type (0.98, 0.99, others) and application (medical pharmaceutical, scientific research). Geographical regions include North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. This segmentation helps in understanding the market dynamics and identifying key growth areas[5].

Drivers and Challenges

The market growth is driven by factors such as increasing infertility rates, advancements in fertility treatments, and growing awareness about assisted reproductive technologies. However, challenges include regulatory hurdles, high costs associated with fertility treatments, and potential side effects of the drug[5].

Key Takeaways

  • Clinical Efficacy: Cetrorelix acetate has been proven effective in inhibiting premature LH surges in women undergoing IVF or ICSI.
  • Safety Profile: The drug has a favorable safety profile with minimal adverse effects.
  • Market Growth: The global cetrorelix acetate market is expected to grow significantly from 2023 to 2031.
  • Regional Impact: The Asia Pacific region is anticipated to be a major driver of market growth.
  • Competitive Landscape: The market is competitive with several key players, and understanding their strategies is crucial for market positioning.

FAQs

What is the primary use of cetrorelix acetate in fertility treatments?

Cetrorelix acetate is used to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation for IVF or ICSI.

What are the common adverse effects of cetrorelix acetate?

The most common adverse effects are local injection site reactions, with no significant systemic side effects reported in clinical trials.

How does the COVID-19 pandemic impact the cetrorelix acetate market?

The pandemic has caused disruptions in supply chains, changes in consumer behavior, and shifts in demand, which have been factored into market projections.

What regions are expected to drive the growth of the cetrorelix acetate market?

The Asia Pacific region is anticipated to be a key driver of market growth due to increasing demand for fertility treatments.

What is the expected growth rate of the cetrorelix acetate market from 2023 to 2031?

The market is expected to exhibit robust growth rates, though the exact CAGR is not specified in the available data.

Sources

  1. ClinicalTrials.gov: Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a GnRH Antagonist Protocol.
  2. Maiaresearch.com: Global Cetrorelix acetate Industry Market Competitive Analysis.
  3. EMA.europa.eu: Cetrotide, INN-Cetrorelix (as acetate) - Scientific Discussion.
  4. FDA.gov: Cetrotide® 0.25 mg (cetrorelix acetate for injection) - Label.
  5. MarketResearchIntellect.com: Global Cetrorelix Acetate API Market Size, Scope And Forecast Report.

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