Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women

PHASE3CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

December 31, 2014

Conditions
AnovulationOligo-ovulationHypothalamic-pituitary DysfunctionPolycystic Ovarian Syndrome
Interventions
DRUG

MSJ-0011

Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 250 microgram (mcg) MSJ-0011 (choriogonadotropin alfa \[recombinant human Chorionic Gonadotropin, r-hCG\]) subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (\>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of \>=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).

DRUG

urinary hCG (u-hCG)

Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of \>=18 mm; not more than 3 follicles each with a mean diameter of \>=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.

DRUG

Follitropin alpha

Low-dose step-up protocol involves starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days (Day 8, 15, 28) will be done if no ovarian response will be observed for maximum of 28 days.

Trial Locations (6)

Unknown

Hanabusa Women's Central Fertility Clinic, Hyōgo

Bashamichi Ladies Clinic, Kanagawa

Sophia Ladies Clinic, Kanagawa

Ivf Namba Clinic, Osaka

Ivf Osaka Clinic, Osaka

Department of Obstetrics and Gynecology, Saitama Medical University Hospital, Saitama

All Listed Sponsors
collaborator

Merck Serono Co., Ltd., Japan

INDUSTRY

lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01653743 - Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women | Biotech Hunter | Biotech Hunter