Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hypogonadotropic Hypogonadism

In brief

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.

Key facts

Study ID: NCT00328926
Run by: EMD Serono
People needed: 11
Starts: 2006-03-01
Expected to finish: 2012-05-01
Last updated by the study team: 2013-08-07

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

U.S. Medical Information, 1-888-275-7376 — Rockland, Massachusetts, United States

Full record on ClinicalTrials.gov

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