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
| Group | Value (percentage of subjects) |
|---|---|
| MSJ-0011 | 100 |
| u-hCG | 100 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataThis trial does not test a peptide that PepBank tracks.
Japan
1 trial · 1 completed · 1 with posted results
Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women
NCT01653743Sept 2012 to Dec 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
MSJ-0011
Active comparator
urinary hCG
Outcomes the sponsor listed as 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
Time frame · Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment
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).
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
Time frame · Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment
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 Endometrial Thickness
Time frame · Day 5 to 7 post hCG treatment
Endometrial thickness was measured using TVUS.
Percentage of Participants With Biochemical Pregnancy
Time frame · Day 35 to 42 post hCG treatment
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 β-hCG pregnancy test on Day 15 to 20 post hCG treatment (Beta-hCG level greater than \[\>\] 10 IU/Liter)
Percentage of Participants With Clinical Pregnancy
Time frame · Day 35 to 42 post hCG treatment
Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of subjects) |
|---|---|
| MSJ-0011 | 100 |
| u-hCG | 100 |
| Group | Value (percentage of subjects) |
|---|---|
| MSJ-0011 | 96.3 |
| u-hCG | 88.9 |
| Group | Value (millimeter) | Spread |
|---|---|---|
| MSJ-0011 | 11.6 | 2.64 |
| u-hCG | 12.4 | 2.58 |
| Group | Value (percentage of subjects) |
|---|---|
| MSJ-0011 | 3.7 |
| u-hCG | 3.7 |
| Group | Value (percentage of subjects) |
|---|---|
| MSJ-0011 | 29.6 |
| u-hCG | 33.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| MSJ-0011Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 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). | – | 1 / 54 | 32 / 54 |
| u-hCGSubjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received 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. | – | 0 / 27 | 11 / 27 |
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