NCT01653743CompletedPhase 3
Open-Label, Parallel-Group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 mcg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Human Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-Ovulation Secondary to Hypothalamic-Pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa
Merck KGaA, Darmstadt, Germany6 sites in 1 country81 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 81
- Locations
- 6
- Primary Endpoint
- 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
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MSJ-0011
Experimental
Intervention: MSJ-0011 (Drug)
MSJ-0011
Experimental
Intervention: Follitropin alpha (Drug)
urinary hCG
Active Comparator
Intervention: urinary hCG (u-hCG) (Drug)
urinary hCG
Active Comparator
Intervention: Follitropin alpha (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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(Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment)
- Mid-luteal Endometrial Thickness(Day 5 to 7 post hCG treatment)
- Percentage of Participants With Biochemical Pregnancy(Day 35 to 42 post hCG treatment)
- Percentage of Participants With Clinical Pregnancy(Day 35 to 42 post hCG treatment)
Investigators
Study Sites (6)
Loading locations...
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