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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR FOLLISTIM

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Clinical Trials for Follistim

Trial ID Title Status Sponsor Phase Summary
NCT00802360 MENOPUR® Versus FOLLISTIM® Completed Ferring Pharmaceuticals Phase 4 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 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.
NCT00884221 MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer Completed Ferring Pharmaceuticals Phase 3 The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH) antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a single embryo was transferred at the blastocyst stage.
NCT00920361 Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED) Completed Merck Sharp & Dohme Corp. N/A To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Follistim

Condition Name

Condition Name for Follistim
Intervention Trials
Infertility 5
Anovulation 1
GnRH Antagonist 1
Fertilization in Vitro 1
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Condition MeSH

Condition MeSH for Follistim
Intervention Trials
Infertility 6
Infertility, Female 1
Anovulation 1
Syndrome 1
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Clinical Trial Locations for Follistim

Trials by Country

Trials by Country for Follistim
Location Trials
United States 15
Japan 5
Denmark 1
Sweden 1
Czech Republic 1
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Trials by US State

Trials by US State for Follistim
Location Trials
Texas 3
New York 2
Illinois 2
Florida 2
Colorado 2
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Clinical Trial Progress for Follistim

Clinical Trial Phase

Clinical Trial Phase for Follistim
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Follistim
Clinical Trial Phase Trials
Completed 7
Recruiting 2
Enrolling by invitation 1
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Clinical Trial Sponsors for Follistim

Sponsor Name

Sponsor Name for Follistim
Sponsor Trials
Ferring Pharmaceuticals 5
Merck Sharp & Dohme Corp. 2
Center for Human Reproduction 1
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Sponsor Type

Sponsor Type for Follistim
Sponsor Trials
Industry 7
Other 3
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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Teva
McKinsey
Medtronic
Daiichi Sankyo
Baxter
Cipla
Merck
Colorcon

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