NCT01863680

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Luteal Hormone Supplementation in In-vitro Fertilization
• Embryo Transfer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-05-29
• Last updated: 2015-12-21
• Results posted: 2015-12-21

Locations

5 sites across 1 country: Japan