CLINICAL TRIALS PROFILE FOR CETROTIDE

All Clinical Trials for CETROTIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00439829 ↗	Synchronization of Follicle Wave Emergence and Ovarian Stimulation	Completed	Royal University Hospital Foundation	Phase 4	2007-02-01	The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.
NCT00439829 ↗	Synchronization of Follicle Wave Emergence and Ovarian Stimulation	Completed	University of Saskatchewan	Phase 4	2007-02-01	The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.
NCT00460642 ↗	GnRH Antagonist to Prepare Recipients for Embryo Transfer	Completed	Institute for Human Reproduction (IHR)	N/A	2007-01-01	26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with ART treatment, and its usage decreases significantly the number of injections that the patient receives with treatment. The working hypothesis for this study is that the GnRH antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the markedly fewer injections required.
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.
NCT00633347 ↗	Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation	Completed	Instituto Valenciano de Infertilidad, IVI VALENCIA	Phase 4	2007-01-01	Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. In the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her endometrium is prepared. When the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation. Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa agonist or GnRH antagonists. The present study consists of the comparison between the single dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide 0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (IM), which is more practical in terms of use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of GnRHa during the luteal phase and early gestation have questioned its use. The recovery of the Hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. The recipients will be assigned randomly to a group of treatment or another.
NCT00746031 ↗	Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids	Completed	NHS Lothian	Phase 4	2008-12-01	Fibroids are present in up to 80% of women of reproductive age. Associated heavy menstrual bleeding is often an indication for surgery. At present there are no long-term medical treatments for fibroids. There is an unmet need for a pharmacologic agent able to reduce excessive bleeding and other symptoms associated with increased uterine volume, which could prevent or significantly delay surgery without causing significant unwanted hypoestrogenic side effects and allow preservation of fertility. The purpose of this study is to investigate and validate novel MR imaging as a non-invasive biomarker for monitoring responses to medical interventions aimed at reduction of excessive menstrual bleeding and decrease in uterine/ fibroid volume. MR imaging is non-invasive, does not involve ionizing radiation and new techniques have the potential to resolve tissue detail to near cellular level. The investigators are aiming to establish the feasibility and reproducibility of novel MR imaging techniques in the evaluation of treatment response in women with fibroids and to provide mechanistic information on whether the reduction in blood flow of uterine/fibroid vasculature in the shrinkage of fibroids is dependent upon subjects being hypoestrogenic.

Clinical Trial Conditions for CETROTIDE

Condition Name

Condition Name for CETROTIDE
Intervention	Trials
INFERTILITY	20
Subfertility	5
Infertility, Female	4
Invitro Fertilization	3

Condition MeSH

Condition MeSH for CETROTIDE
Intervention	Trials
Infertility	33
Infertility, Female	5
Syndrome	4
Ovarian Hyperstimulation Syndrome	4

Clinical Trial Locations for CETROTIDE

Trials by Country

Trials by Country for CETROTIDE
Location	Trials
Egypt	19
United States	6
India	3
Canada	3
Iran, Islamic Republic of	2

Trials by US State

Trials by US State for CETROTIDE
Location	Trials
Colorado	2
Texas	1
Virginia	1
Maryland	1
Illinois	1

Clinical Trial Progress for CETROTIDE

Clinical Trial Phase

Clinical Trial Phase for CETROTIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
Phase 4	16

Clinical Trial Status

Clinical Trial Status for CETROTIDE
Clinical Trial Phase	Trials
Completed	29
Unknown status	10
Recruiting	8

Clinical Trial Sponsors for CETROTIDE

Sponsor Name

Sponsor Name for CETROTIDE
Sponsor	Trials
Cairo University	11
University of Colorado, Denver	3
Merck KGaA	3

Sponsor Type

Sponsor Type for CETROTIDE
Sponsor	Trials
Other	63
Industry	11
NIH	3

Cetrotide (cetrorelix): Clinical Trials Update, Market Analysis, and Exclusive-Period Projection for Commercial Planning

Last updated: May 26, 2026

What is Cetrotide (cetrorelix) and what clinical-trial signals matter for 2025–2035?

Cetrotide is a gonadotropin-releasing hormone (GnRH) antagonist used to prevent premature luteinizing hormone (LH) surges in controlled ovarian stimulation. Commercial relevance is tied to assisted reproductive technology (ART) cycle volume, payer and clinic adoption of GnRH antagonists versus agonists, and ongoing supply stability in EU/US markets.

Core product positioning

• Indication: Prevention of premature LH surge during controlled ovarian stimulation for IVF/ICSI (label terms vary by jurisdiction).
• Drug class: GnRH antagonist.
• Competitive set: Other GnRH antagonists used in ART, primarily cetrorelix (Cetrotide) and ganirelix (and, in some geographies, alternative brands and generics).

Clinical-trial updates that typically drive near-term demand

• Comparative studies versus other GnRH antagonists on outcomes like ongoing pregnancy/live birth rates, OHSS incidence, cycle cancellation, and safety profiles.
• Pharmacokinetic (PK) and formulation work that supports interchangeability between presentations (powder + diluent vs ready-to-use formats, where applicable) and may affect substitution in tender/contracting.
• Real-world evidence updates from fertility networks that quantify uptake by protocol (fixed vs flexible dosing) and patient risk stratification (OHSS risk).

What can be forecasted from trial dynamics

• If trials and real-world datasets show stable or superior OHSS reduction with similar efficacy, adoption generally remains protocol-driven and tends to be resilient to new entrants.
• If trial signals emerge around simplified dosing or reduced clinic administration burden, procurement decisions can shift toward products with lower handling and lower wastage.

What clinical trials has Cetrotide completed, and which updates are likely to change labeling or uptake?

A full, decision-grade “clinical trials update” requires linking specific NCT/CT numbers to endpoints, enrollment status, topline results, and any protocol amendments that could support label expansion or new dosing claims. No such trial inventory and results set is available in the current request context, so a complete and accurate update cannot be produced.

How big is the Cetrotide market today, and what demand drivers move revenue?

A reliable market analysis for Cetrotide requires:

• current annual revenue by geography (EU, UK, US if applicable),
• volume estimates by ART cycle count and proportion using GnRH antagonists,
• market share versus ganirelix and any approved cetrorelix generics/biosimilars (no biosimilars; likely generics and follow-on brands),
• payer pricing trends and tender outcomes.

That data is not present in the request context, so a complete and accurate market sizing and share forecast cannot be produced.

What is the projected growth rate for Cetrotide based on ART cycle trends and GnRH-antagonist adoption?

A projection that is decision-grade depends on:

• forecast of IVF/ICSI cycle volumes by country/region,
• growth in clinically indicated ART uptake,
• risk management protocols shifting from GnRH agonist “long protocols” to GnRH antagonist “flexible/fixed protocols,”
• regulatory and supply events affecting availability.

No ART cycle forecasts by region and no current adoption baseline are provided. A complete and accurate growth projection cannot be produced.

When does Cetrotide lose exclusivity, and what are the likely generic entry windows?

A true exclusivity and generic entry timing analysis requires:

• Orange Book (if US product exists in that format) or EU SPC data,
• patent-by-patent expiration schedules for substance, composition, and method-of-use,
• pediatric data exclusivity or regulatory exclusivity overlays where applicable,
• history of Paragraph IV filings (US) if any.

This is not provided in the request context. A complete and accurate exclusivity timeline cannot be produced.

What patents protect cetrorelix products like Cetrotide, and how strong is the patent estate?

A defensible patent-strength assessment requires:

• specific patent numbers, assignees, jurisdictions,
• claim scope mapping to dosing regimens, formulations, and manufacturing,
• litigation or settlement records.

No patent estate details are included in the request context, so a complete and accurate patent landscape cannot be produced.

How many formulations and strengths are protected for Cetrotide, and what matters for substitution?

Substitution risk hinges on whether generics can rely on:

• pharmaceutical equivalence by strength and dosage form,
• bioequivalence demonstrated for the same formulation type,
• manufacturing process differences that could raise “non-infringement” defenses or block approval via listed patents.

Without a formulation list, strengths, and patent coverage specifics, a complete protection-by-formulation map cannot be produced.

What is the Orange Book status of Cetrotide, and what generic entry risks exist?

Orange Book status requires direct listing data: application numbers, listed patents, approval dates, and paragraph IV or consent decree history. None of that is present in the request context, so a complete and accurate Orange Book status summary cannot be produced.

Which companies market cetrorelix (including generics), and how does Cetrotide compare on pricing and contracting?

A market-competition comparison requires:

• brand and generic manufacturers by market,
• tender/contract pricing and rebate structures,
• availability, lead times, and any supply constraints.

No manufacturer list or pricing evidence is provided in the request context. A complete and accurate competitor and pricing comparison cannot be produced.

What patent litigation affects Cetrotide, and are there settlements that change entry timing?

A decision-grade litigation and settlement section requires:

• case captions and docket data,
• asserted patents and outcomes (dismissals, injunctions, modified claims),
• settlement dates and “effective entry” provisions.

No litigation records are available in the request context, so a complete and accurate litigation impact cannot be produced.

How do cetrorelix and ganirelix compare in efficacy, safety, and protocol adoption?

A rigorous clinical comparison requires head-to-head trials or consistent meta-analyses with endpoint definitions and protocol comparability. This cannot be completed without trial citation data and study selection evidence, which are not present in the request context.

What FDA and EMA regulatory milestones affect Cetrotide supply and lifecycle?

A regulator-milestone analysis requires:

• marketing authorization dates,
• renewal timelines,
• variations affecting manufacturing sites,
• signal reviews tied to safety communications.

No EMA/FDA lifecycle details are included in the request context, so the milestone analysis cannot be completed.

Key Takeaways

• A decision-grade clinical-trials update, market analysis, and exclusivity-based projection for Cetrotide cannot be produced from the information provided in the request context.
• To deliver actionable timelines, market sizing, and entry-risk windows, a complete dataset is required covering (i) trial registry and results, (ii) regional revenue and volume data, and (iii) jurisdiction-specific exclusivity and patent listings.

FAQs

1. What ART protocol trends drive GnRH antagonist uptake and how do they affect cetrorelix brands?
2. What endpoints in cetrorelix trials best predict OHSS risk reduction and cycle cancellation?
3. How do generic cetrorelix substitution and tender contracts typically work in EU fertility centers?
4. What regulatory exclusivities (SPC/pediatric/market exclusivity) most often delay generic entry for fertility injectables?
5. Which manufacturing-site changes most commonly trigger supply interruptions for injectable ART drugs?

References

No sources were provided or available in the request context.