Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel

NCT ID: NCT01863680

Last Updated: 2015-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-10-31

Brief 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.

Conditions

Luteal Hormone Supplementation in In-vitro Fertilization; Embryo Transfer

Keywords

Infertility; COL-1620; progesterone gel; Fertilization in Vitro; Embryo Transfer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COL-1620

Group Type: EXPERIMENTAL

COL-1620

Intervention Type: DRUG

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.

Gonadotropin-releasing hormone (GnRH) analogue

Intervention Type: DRUG

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.

Follicle-stimulating hormone (FSH)

Intervention Type: DRUG

Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation.

Human Chorionic Gonadotropin (hCG)

Intervention Type: DRUG

Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.

Interventions

COL-1620

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.

Intervention Type: DRUG

Gonadotropin-releasing hormone (GnRH) analogue

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.

Intervention Type: DRUG

Follicle-stimulating hormone (FSH)

Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation.

Intervention Type: DRUG

Human Chorionic Gonadotropin (hCG)

Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono Co., Ltd., Japan

Locations

Research site

Fujimino, , Japan

Research site

Kobe, , Japan

Research site

Osaka, , Japan

Research site

Sagamihara, , Japan

Research site

Yokohama, Kanagawa, , Japan

Countries

Japan

Other Identifiers

EMR200113_001

Identifier Type: -

Identifier Source: org_study_id