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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01653743
Other study ID # EMR701173_002
Secondary ID
Status Completed
Phase Phase 3
First received July 20, 2012
Last updated December 1, 2015
Start date September 2012
Est. completion date December 2014

Study information

Verified date December 2015
Source Merck KGaA
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
Japan Hanabusa Women's Central Fertility Clinic Hyogo
Japan Bashamichi Ladies Clinic Kanagawa
Japan Sophia Ladies Clinic Kanagawa
Japan Ivf Namba Clinic Osaka
Japan Ivf Osaka Clinic Osaka
Japan Department of Obstetrics and Gynecology, Saitama Medical University Hospital Saitama

Sponsors (2)

Lead Sponsor Collaborator
Merck KGaA Merck Serono Co., Ltd., Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy Ovulation was defined as mid-luteal serum progesterone level of >= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS). Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment No
Secondary Percentage of Subjects With Ovulation Mid-Luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 9.4 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy Ovulation was defined as mid-luteal serum progesterone level of >= 9.4 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS. Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment No
Secondary Mid-luteal Endometrial Thickness Endometrial thickness was measured using TVUS. Day 5 to 7 post hCG treatment No
Secondary Percentage of Participants With Biochemical Pregnancy Percentage of subjects with biochemical pregnancy was assessed. Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS on the Day 35 to 42 post hCG treatment, but with a positive serum ß-hCG pregnancy test on Day 15 to 20 post hCG treatment (Beta-hCG level greater than [>] 10 IU/Liter) Day 35 to 42 post hCG treatment No
Secondary Percentage of Participants With Clinical Pregnancy Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS. Day 35 to 42 post hCG treatment No
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