Luveris�(Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (LH <1.2 IU/L)

Condition(s) targeted: Hypogonadotropic Hypogonadism

Intervention: Placebo (Drug); lutropin alfa (Drug); lutropin alfa (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Zourab Bebia, MD, Study Director, Affiliation: Merck Serono S.A. - Geneva, an Affiliate of Merck KGaA, Darmstadt, Germany

Overall contact:
U.S. Medical Information, Phone: 888-275-7376

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).

Official title: A Phase IV , Multicenter, Randomized, Double-blinded, Clinical Trial to Confirm the Efficacy of the 75 IU Dose of Luveris® vs. Placebo When Administered With Follitropin Alfa for Induction of Follicular Development and Pregnancy in Hypogonadotropic Hypogonadal Women With Profound LH Deficiency, as Defined by a Baseline LH Level <1.2 IU/L.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to clinical pregnancy. Clinical pregnancy will be determined as the presence of a fetal sac and heartbeat on pelvic ultrasound 35-42 days post-hCG.

Secondary outcome: Follicular Development, Ovulation and Cumulative Pregnancy Rate

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

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

- Have a clinical history of hypogonadotropic hypogonadism.

- Have no prior treatment cycles with gonadotropins or 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:

FSH: <5 IU/L LH: <1. 2 IU/L

- Have an endovaginal pelvic ultrasound scan showing (i) no clinically significant

uterine abnormality, (ii) no ovarian tumor or cyst, and (iii) £13 small follicles (mean diameter £10 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 kg/m2

- 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.

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. In case of doubt this should be discussed with Serono's Medical Director.

- Ongoing pregnancy

- Clinically important systemic disease (e. g. insulin-dependent diabetes mellitus,

epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma).

- Known infection with 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 CNS Lesions: In cases where HH is secondary to a CNS lesion or its treatment,

the subject will not be eligible without consulting Serono's Medical Director.

- 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 (e. g. neuroleptics, dopamine antagonists). Any questions about specific medications should be addressed to Serono's Medical Director

U.S. Medical Information, Phone: 888-275-7376

U.S. Medical Information, Rockland, Massachusetts 02370, United States; Recruiting

Full FDA approved prescribing information can be found here

Starting date: October 2005
Last updated: March 1, 2011