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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR UROFOLLITROPIN

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Clinical Trials for Urofollitropin

Trial ID Title Status Sponsor Phase 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 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 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.
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 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.
NCT01923194 Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females Completed Ferring Pharmaceuticals Phase 3 Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females
NCT02275169 FSH Treatment for Non-obstructive Azoospermic Patients Not yet recruiting Minia University Phase 3 Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.
NCT02275169 FSH Treatment for Non-obstructive Azoospermic Patients Not yet recruiting Azienda Sanitaria Locale Bari Phase 3 Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.
NCT02739516 Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility Completed Benha University Phase 3 The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Urofollitropin

Condition Name

Condition Name for Urofollitropin
Intervention Trials
Infertility 2
Female Infertility 1
Azoospermia 1
Anovulation 1
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Condition MeSH

Condition MeSH for Urofollitropin
Intervention Trials
Infertility 4
Pituitary Diseases 1
Infertility, Female 1
Azoospermia 1
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Clinical Trial Locations for Urofollitropin

Trials by Country

Trials by Country for Urofollitropin
Location Trials
China 14
Japan 1
Sweden 1
Poland 1
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Clinical Trial Progress for Urofollitropin

Clinical Trial Phase

Clinical Trial Phase for Urofollitropin
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Urofollitropin
Clinical Trial Phase Trials
Completed 4
Recruiting 1
Not yet recruiting 1
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Clinical Trial Sponsors for Urofollitropin

Sponsor Name

Sponsor Name for Urofollitropin
Sponsor Trials
Ferring Pharmaceuticals 3
Merck KGaA 1
Merck Serono Co., Ltd., Japan 1
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Sponsor Type

Sponsor Type for Urofollitropin
Sponsor Trials
Industry 5
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Healthtrust
Queensland Health
Cipla
Harvard Business School
Federal Trade Commission
Deloitte
Boehringer Ingelheim
US Department of Justice

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