Completed
PHASE3
INTERVENTIONAL
NCT01863680
Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
COL-1620
Type:
DRUG
Description:
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.
Name:
Gonadotropin-releasing hormone (GnRH) analogue
Type:
DRUG
Description:
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.
Name:
Follicle-stimulating hormone (FSH)
Type:
DRUG
Description:
Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation.
Name:
Human Chorionic Gonadotropin (hCG)
Type:
DRUG
Description:
Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.
Primary Outcomes
Measure:
Clinical Pregnancy Rate Per Embryo Transfer
TimeFrame:
Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])
Description:
Clinical pregnancy was defined as the presence of a fetal sac on transvaginal ultrasound (TVUS) during Week 5 or the presence of an extra-uterine pregnancy (as confirmed during surgery or by 2 positive serum beta-human chorionic gonadotropin (beta-hCG) results from Week 5). The clinical pregnancy rate was calculated as number of subjects who were clinically pregnant divided by the number of subjects who had at least 1 embryo transferred.
Trial Information
NCT ID
NCT01863680
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Merck KGaA, Darmstadt, Germany
Last Updated
December 15, 2025