Clinical trial NCT01863680: Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Luteal Hormone Supplementation in In-vitro Fertilization
Embryo Transfer
Keywords: Infertility
COL-1620
progesterone gel
Fertilization in Vitro
Embryo Transfer
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 178
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical Pregnancy Rate Per Embryo Transfer
timeFrame: Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])
Secondary outcomes:
measure: Biochemical Pregnancy Rate Per Embryo Transfer
timeFrame: Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])
measure: Serum Progesterone Level
timeFrame: Visit 2-2 (Prior to hCG administration) and Visit 5 (Day 14+/-3)
Other outcomes:
Locations:
city: Fujimino
country: Japan
facility: Research site
city: Kobe
country: Japan
facility: Research site
city: Osaka
country: Japan
facility: Research site
city: Sagamihara
country: Japan
facility: Research site
city: Yokohama, Kanagawa
country: Japan
facility: Research site
Study officials:
affiliation: Merck Serono Co., Ltd., Japan
name: Medical Responsible
role: STUDY_DIRECTOR
References: