CLINICAL TRIALS PROFILE FOR CETRORELIX

All Clinical Trials for Cetrorelix

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00244452 ↗	A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed End	Completed	Solvay Pharmaceuticals	Phase 2	2005-11-01	Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief
NCT00449150 ↗	Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)	Terminated	AEterna Zentaris	Phase 3	2007-03-01	Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement. For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).
NCT00505817 ↗	GnRH Agonist and Antagonists in an Oocyte Donation Program	Completed	Instituto Valenciano de Infertilidad, IVI VALENCIA	Phase 4	1969-12-31	The primary purpose of this study is to evaluate the effect of the two different protocols (long protocol vs antagonist protocol) on oocyte / embryo quality.
NCT00507780 ↗	Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy	Withdrawn	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2007-07-18	This study will examine whether the drug cetrorelex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.

Clinical Trial Conditions for Cetrorelix

Condition Name

Condition Name for Cetrorelix
Intervention	Trials
Infertility	18
Intracytoplasmic Sperm Injection	5
In Vitro Fertilization	5
Subfertility	4

Condition MeSH

Condition MeSH for Cetrorelix
Intervention	Trials
Infertility	30
Polycystic Ovary Syndrome	6
Syndrome	6
Infertility, Female	6

Clinical Trial Locations for Cetrorelix

Trials by Country

Trials by Country for Cetrorelix
Location	Trials
United States	56
Egypt	13
Spain	5
Canada	5
China	5

Trials by US State

Trials by US State for Cetrorelix
Location	Trials
Maryland	3
Colorado	3
Kentucky	2
Indiana	2
Georgia	2

Clinical Trial Progress for Cetrorelix

Clinical Trial Phase

Clinical Trial Phase for Cetrorelix
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	13
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for Cetrorelix
Clinical Trial Phase	Trials
Completed	24
Unknown status	14
Recruiting	10

Clinical Trial Sponsors for Cetrorelix

Sponsor Name

Sponsor Name for Cetrorelix
Sponsor	Trials
Cairo University	8
Damascus University	4
AEterna Zentaris	4

Sponsor Type

Sponsor Type for Cetrorelix
Sponsor	Trials
Other	56
Industry	17
NIH	2

Cetrorelix Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Cetrorelix acetate, marketed under the brand name Cetrotide®, is a gonadotropin-releasing hormone (GnRH) antagonist used primarily in the context of controlled ovarian stimulation (COS) for women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Here, we delve into the clinical trials, market analysis, and projections for this crucial fertility drug.

Clinical Trials Overview

Phase 2 and Phase 3 Studies

Clinical trials for Cetrotide® have been extensive, involving several phases to establish its efficacy and safety. In Phase 2 studies, a single dose of 3 mg and a multiple dose regimen of 0.25 mg were investigated. The single 3 mg dose was found to be the minimal effective dose for inhibiting premature luteinizing hormone (LH) surges, providing protection for at least 4 days. The multiple dose regimen of 0.25 mg was also established as effective, with the extent and duration of LH suppression being dose-dependent[1].

In Phase 3 studies, the efficacy of both the single 3 mg dose and the multiple 0.25 mg dose regimens was confirmed in separate clinical trials using active comparators. These studies involved 732 patients and included outcomes such as oocyte pick-up, IVF, ICSI, and embryo transfer. The results showed no drug-related allergic reactions, highlighting the safety profile of Cetrotide®[1].

Comparative Studies

A recent clinical trial aimed to compare the clinical outcomes of generic versus reference cetrorelix acetate in GnRH antagonist protocols for ovarian stimulation in women undergoing IVF or ICSI. This study administered daily doses of either generic or original cetrorelix acetate (0.25 mg subcutaneously) when the lead follicle reached 14 mm. The study's primary goal was to determine if the generic cetrorelix acetate is non-inferior to the reference product, which is crucial for ensuring the availability of affordable and effective treatment options[4].

Market Analysis

Current Market Size and Growth

The global cetrorelix acetate market has been growing steadily. As of 2018, the market size was valued at a significant amount, and it is projected to expand at a compound annual growth rate (CAGR) from 2019 to 2025. This growth is driven by increasing demand for fertility treatments and advancements in reproductive medicine[2].

Market Competition

The market for cetrorelix acetate is competitive, with several companies vying for market share. The competition is analyzed by company and by country, including the USA, EU, Japan, and China. Market analysis also includes consumption by application and type, providing a comprehensive view of the market dynamics[2].

Supply and Demand

Recent manufacturing issues with Merck KGaA's subsidiary EMD Serono led to a shortage of Cetrotide in several European countries. Despite the technical problems being resolved and production resuming, the incident highlighted the importance of reliable supply chains in meeting the demand for this critical drug[5].

Market Projections

Global and Chinese Market Forecast

From 2024 to 2029, the global and Chinese cetrorelix acetate market is expected to see significant growth. Projections include increases in capacity, production, and production value. The market share, supply, and consumption are also expected to rise, driven by growing demand for fertility treatments and improvements in manufacturing technology[2].

Economic Impact

The macroeconomic environment, both globally and in China, plays a crucial role in the market's growth. Factors such as government initiatives, funding for clinical trials, and overall economic stability are expected to positively impact the cetrorelix acetate market. The global clinical trials market, valued at USD 84.61 billion in 2024, is also projected to grow, further supporting the demand for drugs like cetrorelix acetate[2][3].

Industry Development Opportunities and Challenges

The cetrorelix acetate market faces both opportunities and challenges. Opportunities include the increasing prevalence of chronic diseases and the rise in government initiatives supporting clinical trials. However, challenges such as manufacturing issues, as seen with Merck KGaA, and the need for continuous innovation in drug development must be addressed to ensure sustained growth[2][3].

Key Takeaways

• Clinical Efficacy: Cetrorelix acetate has been proven effective in inhibiting premature LH surges in women undergoing COS for IVF or ICSI.
• Market Growth: The global cetrorelix acetate market is projected to grow significantly from 2019 to 2025, driven by increasing demand for fertility treatments.
• Supply Chain: Reliable supply chains are crucial to meet the demand for cetrorelix acetate, as highlighted by recent manufacturing issues.
• Economic Impact: The market is influenced by global and Chinese macroeconomic environments and government initiatives supporting clinical trials.
• Industry Dynamics: The market faces opportunities and challenges, including the need for continuous innovation and addressing manufacturing issues.

FAQs

What is cetrorelix acetate used for?

Cetrorelix acetate is used for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation for IVF or ICSI.

What are the common dosages of cetrorelix acetate?

The common dosages are a single 3 mg dose or a multiple dose regimen of 0.25 mg per day.

What were the findings of the Phase 3 clinical trials for cetrorelix acetate?

The Phase 3 trials confirmed the efficacy of both the single 3 mg dose and the multiple 0.25 mg dose regimens in preventing premature LH surges, with no reported drug-related allergic reactions.

Why did a shortage of cetrorelix acetate occur in Europe?

A manufacturing issue with Merck KGaA's subsidiary EMD Serono led to a shortage of cetrorelix acetate in several European countries.

What is the projected growth of the global cetrorelix acetate market?

The market is projected to expand at a CAGR from 2019 to 2025, driven by increasing demand for fertility treatments and advancements in reproductive medicine.

Sources

1. FDA Label for Cetrotide: AccessData FDA, "Cetrotide® 0.25 mg (cetrorelix acetate for injection)".
2. Cetrorelix Acetate Market Report: Prof-Research, "Cetrorelix acetate Market Size, Share, Trend and Forecast to 2025".
3. Global Clinical Trials Market: StraitsResearch, "Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2024-2033".
4. Clinical Trial for Generic Cetrorelix: Veeva, "Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation".
5. EMA Warning on Cetrotide Shortage: FiercePharma, "Merck KGaA manufacturing issue leads to shortage of IVF drug Cetrotide".