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Generated: February 17, 2019

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CLINICAL TRIALS PROFILE FOR ENDOMETRIN

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Clinical Trials for Endometrin

Trial ID Title Status Sponsor Phase Summary
NCT00296478 Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF) Completed Ferring Pharmaceuticals Phase 3 This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
NCT00345306 Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan Suspended Hadassah Medical Organization Phase 4 The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.
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.
NCT00919919 Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Unknown status Ferring Pharmaceuticals Phase 2 The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
NCT00919919 Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Unknown status Rabin Medical Center Phase 2 The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Endometrin

Condition Name

Condition Name for Endometrin
Intervention Trials
Infertility 6
Focus: Prevent Preterm Delivery 1
Reproductive Behavior 1
Fertility 1
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Condition MeSH

Condition MeSH for Endometrin
Intervention Trials
Infertility 6
Endometrial Hyperplasia 1
Syndrome 1
Polycystic Ovary Syndrome 1
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Clinical Trial Locations for Endometrin

Trials by Country

Trials by Country for Endometrin
Location Trials
United States 28
Israel 3
Iran, Islamic Republic of 1
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Trials by US State

Trials by US State for Endometrin
Location Trials
Illinois 5
Texas 3
Colorado 3
Rhode Island 2
New York 2
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Clinical Trial Progress for Endometrin

Clinical Trial Phase

Clinical Trial Phase for Endometrin
Clinical Trial Phase Trials
Phase 4 5
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Endometrin
Clinical Trial Phase Trials
Completed 5
Recruiting 4
Unknown status 2
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Clinical Trial Sponsors for Endometrin

Sponsor Name

Sponsor Name for Endometrin
Sponsor Trials
Ferring Pharmaceuticals 6
Fertility Centers of Illinois 1
Royan Institute 1
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Sponsor Type

Sponsor Type for Endometrin
Sponsor Trials
Other 11
Industry 6
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Colorcon
Express Scripts
QuintilesIMS
Queensland Health
AstraZeneca
Fuji
Cantor Fitzgerald
US Army

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