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

Merck KGaA (EMD Serono) logo

Merck KGaA (EMD Serono)

Status and phase

Completed
Phase 3

Conditions

Luteal Hormone Supplementation in In-vitro Fertilization
Embryo Transfer

Treatments

Drug: COL-1620
Drug: Human Chorionic Gonadotropin (hCG)
Drug: Gonadotropin-releasing hormone (GnRH) analogue
Drug: Follicle-stimulating hormone (FSH)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01863680
EMR200113_001

Details and patient eligibility

About

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.

Enrollment

178 patients

Sex

Female

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

178 participants in 1 patient group

COL-1620
Experimental group
Treatment:
Drug: Gonadotropin-releasing hormone (GnRH) analogue
Drug: Follicle-stimulating hormone (FSH)
Drug: COL-1620
Drug: Human Chorionic Gonadotropin (hCG)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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