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

PHASE3CompletedINTERVENTIONAL
Enrollment

178

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Luteal Hormone Supplementation in In-vitro FertilizationEmbryo Transfer
Interventions
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.

Trial Locations (5)

Unknown

Research site, Fujimino

Research site, Kobe

Research site, Osaka

Research site, Sagamihara

Research site, Yokohama, Kanagawa

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01863680 - Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel | Biotech Hunter | Biotech Hunter