Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel
Condition: Luteal Hormone Supplementation in In-vitro Fertilization; Embryo Transfer
Intervention: COL-1620; Gonadotropin-releasing hormone (GnRH) analogue; Follicle-stimulating hormone (FSH); Human Chorionic Gonadotropin (hCG)
Intervention description: The subjects will be administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8 percent [%] gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12.; Subjects will undergo conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation.; Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation.; Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.
Intervention MeSH terms: Chorionic Gonadotropin; Hormones; Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: Female
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Infertility; COL-1620; progesterone gel; Fertilization in Vitro; 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