trial to assess the clinical efficacy and safety of msj-0011 in inducing ovulation in anovulatory or oligo-ovulatory japanese women

Conditions: Anovulation; Oligo-ovulation; Hypothalamic-pituitary Dysfunction; Polycystic Ovarian Syndrome

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.


Eligibility criteria:
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

Keywords: japanese