phase 3 trial to evaluate the efficacy and safety of col-1620 vaginal progesterone gel

Conditions: Luteal Hormone Supplementation in In-vitro Fertilization; Embryo Transfer

Summary: the primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (ivf)/embryo transfer (et) cycles in japan (japan society of obstetrics and gynecology \[jsog\] 2009 registry data: 24.3 percent \[%\]). the secondary objectives of this trial are to assess the biochemical pregnancy rate per et, pharmacokinetics, and safety of col-1620.


Eligibility criteria:
inclusion criteria: * japanese race * woman with a history of infertility and in whom in-vitro fertilization and embryo transfer (ivf/et) is indicated * the controlled ovarian stimulation (cos) therapy is gonadotropin-releasing hormone (gnrh) analogue (agonist or antagonist) in combination with a follicle-stimulating hormone (fsh) containing preparation * healthy premenopausal woman aged between 20 and 45 years (inclusive) and wishing to conceive * body mass index (bmi) of 17.0 to 25.0 kilogram per square meter (kg/m\^2) (inclusive) * a negative pregnancy test (urinary beta-human chorionic gonadotropin \[hcg\]) prior to starting cos * normal cervical smear result (papanicolaou \[pap\] test: negative for intraepithelial lesion or malignancy \[nilm\] or \[atypical squamous cells of undetermined significance {asc-us} and human papillomavirus {hpv} negative\]) within 12 months prior to the date of informed consent. if not available, a cervical smear and hpv test will be performed as part of screening * no clinically significant abnormal findings in the screening hematology, biochemistry and urinalysis parameters * full comprehension of the study and voluntary written informed consent obtained in writing prior to any trial-related activities exclusion criteria: * history of recurrent pregnancy loss (defined as 3 or more previous spontaneous abortions) * history of 3 or more consecutive cancelled or failed (no clinical pregnancy) ivf/et cycles * abnormal hemorrhage of the reproductive tract of undetermined origin * any contraindication to being pregnant and/or carrying a pregnancy to term (for example, malformations of sexual organs or fibroid tumors of the uterus incompatible with pregnancy) * uterine myoma requiring treatment * extra-uterine pregnancy within the last 3 months prior to the date of informed consent * history or presence of intracranial tumor (for example, hypothalamic or pituitary tumor) * presence of or suspected gonadotropin- or estrogen-dependent malignancy (for example, ovarian, uterine or mammary carcinoma) * ovarian enlargement or cyst of unknown etiology * breast-feeding or lactation * history of severe ovarian hyperstimulation syndrome (ohss) (classification of ohss severity, as per japan reproductive/endocrine working group) * known human immunodeficiency virus (hiv)-positive status, or a history of or current active infection with hepatitis b or c * known allergy or hypersensitivity to progesterone preparations or gonadotropin preparations and/or their excipients, or any contraindication to receive medication for controlled ovarian stimulation (for example, gonadotropin, gnrh analogues, combined oral contraceptive pill, as appropriate) * history of or suspected alcohol or substance abuse within 5 years prior to the date of informed consent * clinically significant systemic disease (for example, insulin-dependent diabetes, epilepsy, severe migraine, acute porphyria, hepatic, renal or cardiovascular disease, severe corticosteroid-dependent asthma) * active thrombophlebitis, thromboembolic disorder or cerebral apoplexy, or a history of such conditions * other significant disease that in the investigator's or sub-investigator's opinion would exclude the subject from the trial * participation in another clinical trial within 3 months prior to the date of informed consent or simultaneous participation in another clinical trial * legal incapacity or limited legal capacity

Keywords: infertility col-1620 progesterone gel fertilization in vitro embryo transfer