Luveris®(Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (LH <1.2 IU/L) - Full Text View

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00328926

Purpose

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).

Condition	Intervention	Phase
Hypogonadotropic Hypogonadism	Drug: Placebo Drug: lutropin alfa	Phase IV

Drug Information available for: Follitropin beta Urofollitropin Follicle Stimulating Hormone BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by EMD Serono:

Primary Outcome Measures:

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. [ Time Frame: 35-42 days post-hCG ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Follicular Development, Ovulation and Cumulative Pregnancy Rate [ Time Frame: Various time points ] [ Designated as safety issue: No ]

Estimated Enrollment:	234
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Gonal-f® + a placebo	Drug: Placebo Subcutaneous injection once daily until criteria for ovulation triggering is met (21 day max)
2: Experimental Gonal-f® + lutropin alfa 25 IU	Drug: lutropin alfa Once daily Subcutaneous injection until criteria for ovulation triggering is met (21 day max)
3 Gonal-f® + lutropin alfa 75 IU	Drug: lutropin alfa Once daily subcutaneous injection until criteria for ovulation triggering is met (21 day max)

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328926

Contacts

Contact: U.S. Medical Information

888-275-7376

Locations

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

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Donald R Tredway, M.D., PhD

EMD Serono

More Information

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

Responsible Party:	EMD Serono, Inc. ( Stephanie Ruhl, Clinical Trial Manager )
Study ID Numbers:	26109
Study First Received:	May 20, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00328926
Health Authority:	United States: Food and Drug Administration

Keywords provided by EMD Serono:

Hypogonadotropic Hypogonadism (LH <1.2 IU/L)

Study placed in the following topic categories:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Endocrinopathy
Follicle Stimulating Hormone

ClinicalTrials.gov processed this record on January 15, 2009