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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Anovulation

Polycystic Ovarian Syndrome

Oligo-ovulation

Hypothalamic-pituitary Dysfunction

Treatments

Drug: Follitropin alpha

Drug: urinary hCG (u-hCG)

Drug: MSJ-0011

Study type

Interventional

Funder types

Industry

Identifiers

NCT01653743

EMR701173_002

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

Female

Ages

20 to 39 years old

Volunteers

No Healthy Volunteers

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