Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of
 customer demand for this product, and not due to any efficacy or safety concerns.
To confirm the efficacy of the 75 IU dose of Luveris® compared to placebo when administered
 concomitantly with follitropin alfa for induction of clinical pregnancy in women with
 hypogonadotropic hypogonadism and profound LH deficiency (LH <1.2 IU/L), and to study the
 efficacy of a lower dose (25 IU) of Luveris® compared to placebo when administered
 concomitantly with follitropin alfa for induction of follicular development in women with
 hypogonadotropic hypogonadism and profound LH deficiency (LH <1.2 IU/L).
Inclusion Criteria:

 -  Be premenopausal, between 18 and 40 years of age inclusive on the day of consent

 -  Have a clinical history of hypogonadotropic hypogonadism (World health organization
 [WHO] Group I type of anovulation) on the basis of congenital or acquired hypothalamic
 or pituitary endocrine dysfunction in the presence of qualifying screening
 laboratories

 -  Have no prior treatment cycles with gonadotropins or gonadotropin releasing hormone
 (GnRH) (gonadotropin naïve)

 -  Have discontinued estrogen-progesterone replacement therapy at least one month before
 the screening procedure

 -  Have primary or secondary amenorrhea

 -  Have a negative progestin challenge test performed during Screening

 -  Have the following hormonal values in a centrally analyzed fasting blood sample, drawn
 within 6 weeks before initiation of treatment:

 -  Follicle-Stimulating Hormone (FSH): less than (<)5 international unit per liter
 (IU/L)

 -  Leutinizing hormone (LH): <1.2 IU/L (a second Baseline serum LH level will be
 repeated two weeks after the initial LH draw)

 -  Prolactin: < 43.3 nanogram per milliliter (ng/mL) (<1040 milli-international unit
 per liter [mIU/L])

 -  Thyroid Stimulating Hormone (TSH): <6.5 micro-international units per milliliter
 (mcIU/mL)

 -  Free Thyroxin (T4): 0.8-1.8 nanogram per deciliter (ng/dL) (11-24 picomole per
 liter [pmol/L])

 -  Testosterone: <1.0 ng/mL (<3.5 nanomole per liter [nmol/L])

 -  Have an endovaginal pelvic ultrasound scan showing (i) no clinically significant
 uterine abnormality, (ii) no ovarian tumor or cyst, and (iii) less than or equal to
 (=<)13 small follicles (mean diameter =<10 milliliter [mm]) on the largest section
 through each ovary

 -  Have a normal cervical pap smear within 6 months of the initial visit

 -  Where indicated, have a normal or unchanged computed tomography (CT) scan or nuclear
 magnetic resonance (NMR) scan of the hypothalamic pituitary region on file

 -  Have a body mass index (BMI) between 18.4 and 31.4 kilogram per square meter (kg/m^2)

 -  Be willing and able to comply with the protocol for the duration of the study

 -  Have given written informed consent prior to any study related procedure not part of
 normal medical care, with the understanding that consent may be withdrawn by the
 subject at any time without prejudice to her future medical care

 Exclusion Criteria:

 -  Any medical condition which in the judgment of the investigator may interfere with the
 absorption, distribution, metabolism or excretion of the drug

 -  Any pre-existing medical condition which would compromise the subject's ability to
 conceive in vivo or to successfully complete a pregnancy

 -  Ongoing pregnancy

 -  Clinically important systemic disease (example: insulin-dependent diabetes mellitus,
 epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular
 disease, serious corticoid-dependent asthma)

 -  Known infection with human immunodeficiency virus (HIV), Hepatitis B or C

 -  Ovarian enlargement or cyst of unknown etiology

 -  Abnormal gynecological bleeding of undetermined origin

 -  Previous or current hormone dependent tumor

 -  Known active substance abuse or eating disorder

 -  Known central nervous system (CNS) Lesions: In cases where hypogonadotropic
 hypogonadism (HH) is secondary to a CNS lesion or its treatment

 -  Exercise program exceeding 10 hours per week

 -  Is planning to undergo in vitro fertilization, intracytoplasmic sperm injection or
 another assisted reproductive technology (ART) procedure, other than intrauterine
 insemination, in the course of a study treatment cycle

 -  Currently undergoing treatment with psychotropic medication or with any other
 medication known to interfere with normal reproductive function (example:
 neuroleptics, dopamine antagonists)