Status:
COMPLETED
Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Luteal Hormone Supplementation in In-vitro Fertilization
Embryo Transfer
Eligibility:
FEMALE
20-45 years
Phase:
PHASE3
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 tra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01863680
Start Date
July 1 2013
End Date
October 1 2014
Last Update
December 21 2015
Active Locations (5)
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1
Research site
Fujimino, Japan
2
Research site
Kobe, Japan
3
Research site
Osaka, Japan
4
Research site
Sagamihara, Japan