CLINICAL TRIALS PROFILE FOR UROFOLLITROPIN

All Clinical Trials for Urofollitropin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01185782 ↗	SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women	Completed	Merck Serono Co., Ltd., Japan	Phase 3	2007-02-01	Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.
NCT01185782 ↗	SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women	Completed	Merck KGaA	Phase 3	2007-02-01	Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.
NCT01185782 ↗	SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women	Completed	Merck KGaA, Darmstadt, Germany	Phase 3	2007-02-01	Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.
NCT01417195 ↗	Menopur Mixed Protocol	Completed	Ferring Pharmaceuticals	Phase 4	2011-07-01	The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART). Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.
NCT01922193 ↗	Evaluation of Efficacy and Safety of Highly Purified Urofollitropin in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program	Completed	Ferring Pharmaceuticals	Phase 3	2013-10-01	Evaluate the efficacy and safety of of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program.

Clinical Trial Conditions for Urofollitropin

Condition Name

Condition Name for Urofollitropin
Intervention	Trials
Infertility	3
Ovulation Induction	2
Gonadotropins	1
Letrozole	1

Condition MeSH

Condition MeSH for Urofollitropin
Intervention	Trials
Infertility	5
Infertility, Female	1
Azoospermia	1
Anovulation	1

Clinical Trial Locations for Urofollitropin

Trials by Country

Trials by Country for Urofollitropin
Location	Trials
China	14
United States	7
Japan	1
Poland	1
Egypt	1

Trials by US State

Trials by US State for Urofollitropin
Location	Trials
Illinois	1
Georgia	1
Florida	1
Colorado	1
Washington	1

Clinical Trial Progress for Urofollitropin

Clinical Trial Phase

Clinical Trial Phase for Urofollitropin
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5

Clinical Trial Status

Clinical Trial Status for Urofollitropin
Clinical Trial Phase	Trials
Completed	6
Unknown status	1
Recruiting	1

Clinical Trial Sponsors for Urofollitropin

Sponsor Name

Sponsor Name for Urofollitropin
Sponsor	Trials
Ferring Pharmaceuticals	4
Merck Serono Co., Ltd., Japan	1
Merck KGaA	1

Sponsor Type

Sponsor Type for Urofollitropin
Sponsor	Trials
Industry	7
Other	5

Urofollitropin: Clinical Trials, Market Analysis, and Projections

Introduction to Urofollitropin

Urofollitropin is a purified form of human follicle-stimulating hormone (FSH) extracted and purified from human urine samples. It is used primarily to treat infertility in females by inducing follicle development and ovulation. The drug consists of two non-covalently linked glycoproteins, the alpha and beta subunits, each with specific glycosylation sites[2].

Clinical Trials Overview

Current Trials and Status

One notable clinical trial involving urofollitropin is registered in the EU Clinical Trials Register. This trial, with the EudraCT number 2016-004034-14, is sponsored by an unspecified entity and is currently ongoing. The trial focuses on the use of urofollitropin (urofollitropin highly purified) administered via intramuscular or subcutaneous routes. The trial aims to evaluate the efficacy and safety of urofollitropin in a specific patient population, although detailed objectives and outcomes are not publicly disclosed[1].

Previous Studies and Outcomes

Previous studies have evaluated the effects of urofollitropin on male infertility as well. A study published in PubMed aimed to assess the serum levels of total testosterone after treatment with urofollitropin in patients with male infertility and mild reduction in testicular volume. The results showed that treatment with urofollitropin improved follicle-stimulating hormone (FSH) levels, sperm morphology, and total testosterone levels, indicating potential benefits in preventing hypogonadism and improving fertility parameters[4].

Market Analysis

Global Female Infertility Drug Market

The global female infertility drug market, which includes urofollitropin, is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.4% from 2018 to 2028. This growth is driven by an increase in assisted reproductive technology (ART) treatment rates and the launch of new treatments. The market was valued at $1.8 billion in 2018 and is expected to reach $2.5 billion by the end of the forecast period[5].

Market Share and Key Players

In the female infertility drug market, three drugs dominate over 50% of the market share: EMD Serono’s Gonal-F (follitropin alfa), Merck’s Follistim (follitropin beta), and Ferring Pharmaceuticals’ Menopur (menotropins). Urofollitropin, while not as widely marketed as these products, still holds a significant position due to its efficacy and long-standing use in fertility treatments[5].

Drivers of Market Growth

The growth in the female infertility drug market is largely driven by several factors:

• Increasing Age of Pregnancy: Many women are postponing pregnancy until later in life, when fertility naturally decreases, leading to an increased demand for ART treatments[5].
• Advancements in Technology: Improvements in ART and the development of new fertility treatments are expected to drive market growth.
• Rising Awareness: Greater awareness about fertility issues and available treatments is also contributing to the market expansion.

Projections and Future Outlook

Market Size and Growth

The female infertility drug market is expected to continue growing, driven by the factors mentioned above. By 2028, the market is projected to be worth $2.5 billion, up from $1.8 billion in 2018. This growth indicates a steady demand for fertility treatments, including urofollitropin[5].

Emerging Trends and Opportunities

• New Treatments and Technologies: The introduction of new treatments, such as ObsEva’s nolasiban, which is expected to launch in the EU and US, will further drive market growth.
• Expanding Patient Base: As more women seek fertility treatments, the market for drugs like urofollitropin is likely to expand.
• Regulatory Environment: The stringent regulatory environment, while challenging, ensures that only safe and effective treatments reach the market, which can enhance trust and adoption rates.

Conclusion

Urofollitropin remains a significant player in the female infertility drug market due to its efficacy in inducing follicle development and ovulation. Ongoing clinical trials and the growing demand for fertility treatments are expected to sustain the market growth for urofollitropin and similar drugs.

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating the safety and efficacy of urofollitropin in various patient populations.
• Market Growth: The global female infertility drug market is projected to grow at a CAGR of 3.4% from 2018 to 2028.
• Market Share: Urofollitropin competes in a market dominated by Gonal-F, Follistim, and Menopur.
• Drivers of Growth: Increasing age of pregnancy, advancements in ART, and rising awareness about fertility issues are key drivers.
• Future Outlook: The market is expected to expand due to new treatments and an expanding patient base.

FAQs

What is urofollitropin used for?

Urofollitropin is used to treat infertility in females by inducing follicle development and ovulation. It is also used in combination with human chorionic gonadotropin (hCG) to induce ovulation and in procedures like gamete intrafallopian transfer (GIFT) and in vitro fertilization (IVF)[2].

How is urofollitropin administered?

Urofollitropin is typically administered via subcutaneous injection, although it can also be given intramuscularly[1][2].

What are the key drivers of the female infertility drug market?

The key drivers include the increasing age of pregnancy, advancements in assisted reproductive technology (ART), and rising awareness about fertility issues[5].

Which companies dominate the female infertility drug market?

The market is dominated by EMD Serono’s Gonal-F, Merck’s Follistim, and Ferring Pharmaceuticals’ Menopur[5].

What is the projected growth rate of the female infertility drug market?

The market is projected to grow at a CAGR of 3.4% from 2018 to 2028[5].

Sources

1. EU Clinical Trials Register: "EudraCT Number: 2016-004034-14"
2. DrugBank: "Urofollitropin: Uses, Interactions, Mechanism of Action"
3. Biospace: "U.S. Clinical Trials Market Size Industry Analysis Report, 2033"
4. PubMed: "Testosterone levels after treatment with urofollitropin in infertile patients"
5. European Pharmaceutical Review: "Female infertility drug market to exhibit CAGR of 3.4 percent"