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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

This trial does not test a peptide that PepBank tracks.

  • Names hCG (human chorionic gonadotropin), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 3
Enrollment
81 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
Sept 2012
Primary completion
Nov 2014
Completion
Dec 2014
First posted
31 Jul 2012 (estimated)
Last update posted
7 Jan 2016 (estimated)
Conditions
Anovulation · Oligo-ovulation · Hypothalamic-pituitary Dysfunction · Polycystic Ovarian Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 3

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

    NCT01653743

    Sept 2012 to Dec 2014

Registry summary

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.

Interventions

  • MSJ-0011Drug
  • urinary hCG (u-hCG)Drug
  • Follitropin alphaDrug

Arms2

  • Experimental

    MSJ-0011

  • Active comparator

    urinary hCG

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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).

Secondary outcomes(4)
  1. 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

    Registry description

    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.

  2. Mid-luteal Endometrial Thickness

    Time frame · Day 5 to 7 post hCG treatment

    Registry description

    Endometrial thickness was measured using TVUS.

  3. Percentage of Participants With Biochemical Pregnancy

    Time frame · Day 35 to 42 post hCG treatment

    Registry description

    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)

  4. Percentage of Participants With Clinical Pregnancy

    Time frame · Day 35 to 42 post hCG treatment

    Registry description

    Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment

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

GroupValue (percentage of subjects)
MSJ-0011100
u-hCG100
Secondary and other outcome results(4)
Secondary outcomeNumber· Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment

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

GroupValue (percentage of subjects)
MSJ-001196.3
u-hCG88.9
Secondary outcomeMean· Day 5 to 7 post hCG treatment

Mid-luteal Endometrial Thickness

GroupValue (millimeter)Spread
MSJ-001111.62.64
u-hCG12.42.58
Secondary outcomeNumber· Day 35 to 42 post hCG treatment

Percentage of Participants With Biochemical Pregnancy

GroupValue (percentage of subjects)
MSJ-00113.7
u-hCG3.7
Secondary outcomeNumber· Day 35 to 42 post hCG treatment

Percentage of Participants With Clinical Pregnancy

GroupValue (percentage of subjects)
MSJ-001129.6
u-hCG33.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 5432 / 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 / 2711 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 39 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Premenopausal women aged between 20 to 39 years inclusive and wishing to conceive * Body Mass Index (BMI) of 17.0 to 29.0 kilogram per square meter (kg/m\^2) inclusive (value up to first decimal place) * No clinically significant abnormalities in serum thyroid stimulating hormone (TSH), dehydroepiandrosterone sulfate (DHEA-S), 17-hydroxyProgesterone (17-OHP), prolactin (PRL) and follicle-stimulating hormone (FSH) levels in the early follicular phase * Anovulation or oligo-ovulation * Any one of the following: spontaneous menstruation (at least twice per year) or a positive response to progestin as evidenced by menstruation. * Eligible for ovarian stimulation with gonadotropins (e.g. documented failure to ovulate or achieve pregnancy with anti-estrogenic therapy such as clomiphene citrate) * Male partner with normal semen analysis, as defined by World Health Organization (WHO) standards, within 12 months prior to date of informed consent * Normal cervical smear results (Papanicolaou \[PAP\] score less than or equal to \[\<=\] II) taken within 12 months prior to date of informed consent; if not available a cervical smear will be performed as part of screening * Full comprehension of the trial and voluntary consent obtained in writing prior to participation in this trial Exclusion Criteria: * Infertility involving gynecological factors other than anovulation or oligo-ovulation secondary to hypothalamic-pituitary dysfunction (Grade 1 Amenorrhea, Oligomenorrhea or Anovulatory Cycles) or polycystic ovarian syndrome (PCOS) and for whom ovulation induction (OI) therapy is contraindicated * Subjects with known surgical/histological diagnosis of endometriosis greater than Stage II (American Fertility Society classification), or endometriosis requiring treatment * Infertility secondary to amenorrhea of uterine cause * Infertility secondary to primary or premature ovarian failure * Infertility secondary to known adrenal or thyroid dysfunction, or hyperprolactinemia * Failure of ovulation in 2 or more consecutive previous cycles with any gonadotropins * Subjects in whom pregnancy is contraindicated, e.g. malformations of sexual organs or fibroid tumors of the uterus incompatible with pregnancy * Extrauterine pregnancy in the previous 3 months * History or presence of intracranial tumor (e.g. hypothalamic or pituitary tumor) * Presence of or suspected gonadotropin- or estrogen-dependent malignancy (e.g. ovarian, uterine or mammary carcinoma) * Untreated endometrial hyperplasia * Abnormal hemorrhage of the reproductive tract of unknown origin * History of severe ovarian hyper stimulation syndrome (OHSS) (Classification of OHSS Severity, Japan Reproductive/Endocrine Working Group) * Clinically significant systemic disease (e.g. insulin-dependent diabetes, epilepsy, severe migraine, intermittent porphyria, hepatic, renal or cardiovascular disease, severe corticosteroid-dependent asthma) * Participation in another clinical trial within 3 months prior to date of informed consent or simultaneous participation in another clinical trial * Gonadotropin treatment within 2 months prior to date of informed consent * Legal incapacity or limited legal capacity

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