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

This study has been completed.
Information provided by (Responsible Party):
Merck KGaA Identifier:
First received: May 23, 2013
Last updated: November 16, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Luteal Hormone Supplementation in In-vitro Fertilization Embryo Transfer Drug: COL-1620 Drug: Gonadotropin-releasing hormone (GnRH) analogue Drug: Follicle-stimulating hormone (FSH) Drug: Human Chorionic Gonadotropin (hCG) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Single-arm, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of COL-1620 8% Vaginal Progesterone Gel for Luteal Phase Support in In-vitro Fertilization and Embryo Transfer (IVF/ET) Cycles in Japanese Women

Resource links provided by NLM:

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Clinical Pregnancy Rate Per Embryo Transfer [ Time Frame: Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU]) ]
    Clinical pregnancy was defined as the presence of a fetal sac on transvaginal ultrasound (TVUS) during Week 5 or the presence of an extra-uterine pregnancy (as confirmed during surgery or by 2 positive serum beta-human chorionic gonadotropin (beta-hCG) results from Week 5). The clinical pregnancy rate was calculated as number of subjects who were clinically pregnant divided by the number of subjects who had at least 1 embryo transferred.

Secondary Outcome Measures:
  • Biochemical Pregnancy Rate Per Embryo Transfer [ Time Frame: Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU]) ]
    Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS during Visit 6 (Week 5), but with a positive serum beta-hCG pregnancy test result at Visit 5 (Day 14+/-3). Biochemical pregnancy rate was calculated as the number of subjects who had no fetal sac observed during Visit 6 (Week 5) TVUS assessment or subjects who had a positive serum pregnancy test at Visit 5 (Day 14+/-3) and no data recorded at Visit 6 (Week 5) divided by the number of subjects who has at least 1 embryo transferred.

  • Serum Progesterone Level [ Time Frame: Visit 2-2 (Prior to hCG administration) and Visit 5 (Day 14+/-3) ]
    Two pharmacokinetic (PK) samples were collected per subject for the measurement of serum progesterone concentrations; 1st sample at Visit 2-2 (prior to hCG administration) and second sample during Visit 5 (Day 14+/-3, 7 hours after the morning of investigational medicinal product administration).

Enrollment: 178
Study Start Date: July 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COL-1620 Drug: 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.
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.
Drug: Follicle-stimulating hormone (FSH)
Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation.
Drug: Human Chorionic Gonadotropin (hCG)
Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01863680

Research site
Fujimino, Japan
Research site
Kobe, Japan
Research site
Osaka, Japan
Research site
Sagamihara, Japan
Research site
Yokohama, Kanagawa, Japan
Sponsors and Collaborators
Merck KGaA
Study Director: Medical Responsible Merck Serono Co., Ltd., Japan
  More Information

Responsible Party: Merck KGaA Identifier: NCT01863680     History of Changes
Other Study ID Numbers: EMR200113_001
Study First Received: May 23, 2013
Results First Received: November 16, 2015
Last Updated: November 16, 2015

Keywords provided by Merck KGaA:
progesterone gel
Fertilization in Vitro
Embryo Transfer

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Chorionic Gonadotropin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents processed this record on September 21, 2017