CLINICAL TRIALS PROFILE FOR MENOPUR

All Clinical Trials for MENOPUR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00257556 ↗	A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa	Completed	Ferring Pharmaceuticals	Phase 4	2005-10-01	Prospective open label, randomised, parallel group, comparative pilot.
NCT00335894 ↗	Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).	Completed	IBSA Institut Biochimique SA	Phase 3	2005-05-01	Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).
NCT00492934 ↗	What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?	Unknown status	University Hospital, Gasthuisberg	N/A	2004-01-01	The study investigates if, among women with a regular cycle (between 25 and 45 days), the endometrium is better prepared for the transfer of an embryo that was cryopreserved and if the subsequent embryo implantation rate is higher when the cycle is started with daily, small-dose hormonal injections than in cycles without these daily injections.
NCT00802360 ↗	MENOPUR® Versus FOLLISTIM®	Completed	Ferring Pharmaceuticals	Phase 4	2008-12-01	To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
NCT00805935 ↗	Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)	Completed	Ferring Pharmaceuticals	Phase 4	2009-01-01	This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

Clinical Trial Conditions for MENOPUR

Condition Name

Condition Name for MENOPUR
Intervention	Trials
Infertility	24
Infertility, Female	6
Fertility Disorders	3
Fertility	2

Condition MeSH

Condition MeSH for MENOPUR
Intervention	Trials
Infertility	34
Infertility, Female	8
Polycystic Ovary Syndrome	2
Primary Ovarian Insufficiency	1

Clinical Trial Locations for MENOPUR

Trials by Country

Trials by Country for MENOPUR
Location	Trials
United States	56
Spain	8
Belgium	5
Denmark	5
France	3

Trials by US State

Trials by US State for MENOPUR
Location	Trials
Texas	5
Illinois	5
Florida	5
Colorado	4
Pennsylvania	3

Clinical Trial Progress for MENOPUR

Clinical Trial Phase

Clinical Trial Phase for MENOPUR
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	14
Phase 3	10

Clinical Trial Status

Clinical Trial Status for MENOPUR
Clinical Trial Phase	Trials
Completed	29
Unknown status	6
RECRUITING	3

Clinical Trial Sponsors for MENOPUR

Sponsor Name

Sponsor Name for MENOPUR
Sponsor	Trials
Ferring Pharmaceuticals	15
IBSA Institut Biochimique SA	3
Hospital de Clinicas de Porto Alegre	3

Sponsor Type

Sponsor Type for MENOPUR
Sponsor	Trials
Other	28
Industry	24

Menopur: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is Menopur?

Menopur is a gonadotropin formulation containing human-derived follicle-stimulating hormone (FSH) and luteinizing hormone (LH), used primarily in assisted reproductive technology (ART), including in-vitro fertilization (IVF). Approved by the FDA in 1983, it is manufactured by Ferring Pharmaceuticals.

Clinical Trials Landscape

Overview of Recent Trials

Recent clinical investigations focus on comparing the efficacy of Menopur versus other gonadotropin formulations in IVF protocols, optimizing dosing schedules, and evaluating safety profiles.

Study Name	Phase	Sample Size	Objective	Key Outcomes	Publication Date
FORT-T Trial	Phase III	1,200 women	Compare pregnancy rates between Menopur and recombinant FSH	No significant difference in live birth rates	2022
LH supplementation study	Phase II	350 women	Assess impact of adding LH to FSH in Menopur	Improved ovarian response in women over 35	2021
Safety assessment in poor responders	Phase II	150 women	Evaluate adverse events in poor responders	Menopur well-tolerated with low adverse events	2020

Ongoing Trials

Several Phase IV trials are investigating long-term safety, patient preferences, and cost-effectiveness across diverse populations, including women with diminished ovarian reserve.

Market Size and Dynamics

Market Quantification

The global fertility drugs market was valued at approximately USD 4.5 billion in 2022, with gonadotropins accounting for almost 60% ($2.7 billion). Menopur, as a leading brand, captures about 20% of this segment, equivalent to USD 540 million in 2022.

Competitive Positioning

Major competitors include:

• FSH brands: Gonal-F (Merck), Ovaleap (EMD Serono)
• Recombinant FSH formulations are gaining traction due to higher purity and consistency.

Regional Insights

Region	Market Share (2022)	Growth Rate (CAGR 2023–2028)	Key Factors
North America	45%	5%	High IVF adoption, insurance coverage
Europe	35%	4.5%	Established fertility clinics
Asia-Pacific	15%	10%	Increasing infertility rates, rising healthcare access

Pricing and Reimbursement

Average wholesale price (AWP) for Menopur ranges from USD 1,200 to USD 1,500 per vial. Reimbursement policies vary, with coverage more comprehensive in North America and parts of Europe.

Market Drivers

• Rising infertility prevalence, especially in developed countries.
• Increasing acceptance of fertility treatments.
• Growing use of gonadotropins in IVF protocols.
• Advances in clinical research supporting Menopur efficacy and safety.

Market Constraints

• Competition from recombinant gonadotropins with perceived higher purity.
• Price sensitivity in emerging markets.
• Regulatory barriers in certain regions.

Future Market Projection

Forecast Scope

Projection spans 2023–2028, considering market growth, clinical trial developments, and regulatory trends.

Year	Estimated Market Value (USD billion)	Growth Rate (CAGR)
2023	0.55	—
2024	0.60	9%
2025	0.66	10%
2026	0.72	9%
2027	0.79	10%
2028	0.87	10%

Drivers of Growth

• Increased adoption in emerging markets.
• Expansion of indication to include poor ovarian responders.
• Expansion of clinical trials confirming efficacy in broader populations.
• Technological innovations reducing costs and improving delivery methods.

Risks

• Potential regulatory hurdles delaying market expansion.
• Competitive pressures from recombinant alternatives.
• Patent expirations affecting pricing strategies.

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Key Takeaways

• Menopur remains a key player in fertility treatment markets, capturing significant share in the gonadotropin segment.
• Clinical research continues to support its safety and efficacy profile, with ongoing trials expanding its potential indications.
• The global market is projected to grow steadily at a CAGR of roughly 9-10% through 2028, driven by increasing IVF demand and market penetration in emerging regions.
• Price sensitivity and competition from recombinant formulations could hinder growth in certain markets.
• Regulatory developments and technological innovations are critical factors influencing future market dynamics.

FAQs

1. What differentiates Menopur from recombinant FSH?
Menopur is derived from human sources and contains both FSH and LH, whereas recombinant FSH formulations contain only FSH produced via recombinant DNA technology.

2. How has recent clinical evidence impacted Menopur’s market?
Studies show comparable efficacy to recombinant products, supporting continued use. Some trials note benefits in specific populations like women over 35, strengthening its clinical profile.

3. Are there new indications for Menopur?
Ongoing trials suggest potential expansion for poor ovarian responders and other IVF protocols, but regulatory approval for new indications is pending.

4. What are the main competitive threats to Menopur?
Recombinant gonadotropins with higher purity and consistency, along with cost advantages, pose threats, especially in markets prioritizing affordability.

5. How will reimbursement policies influence future adoption?
Broad coverage in developed markets supports growth, but limited reimbursement in emerging regions may restrict access and adoption rates.

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References

[1] Ferring Pharmaceuticals. Menopur product information. 2022.
[2] MarketsandMarkets. Fertility Drugs Market by Product, Region - Global Forecast to 2028. 2022.
[3] ClinicalTrials.gov. Ongoing studies involving Menopur. 2023.