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

Inclusion Criteria:

• Premenopausal women aged between 20 to 39 years inclusive and wishing to conceive.
• BMI of 17.0 to 29.0 kg/m2 inclusive (value up to first decimal place).
• No clinically significant abnormalities in serum TSH, DHEA-S, 17-OHP, PRL and 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 WHO standards, within 12 months prior to date of informed consent.
• Normal cervical smear results (PAP score ≤ 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 PCOS, and for whom 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 hyperstimulation 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.