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Last Updated: October 19, 2019

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CLINICAL TRIALS PROFILE FOR UROFOLLITROPIN

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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.
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.
NCT01923194 Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females Completed Ferring Pharmaceuticals Phase 3 2013-10-01 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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Urofollitropin

Condition Name

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

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

Trials by Country

Trials by Country for Urofollitropin
Location Trials
China 14
Poland 1
Japan 1
Sweden 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
Azienda Sanitaria Locale Bari 1
Minia University 1
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Sponsor Type

Sponsor Type for Urofollitropin
Sponsor Trials
Industry 5
Other 4
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