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

This study has been terminated.

(Please see "Purpose" statement)

Sponsor:

Information provided by (Responsible Party):

EMD Serono

ClinicalTrials.gov Identifier:

NCT00328926

First received: May 20, 2006

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2006

Last Updated Date

June 12, 2012

Start Date ^ICMJE

October 2005

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy endpoint is 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.

Change History

Complete list of historical versions of study NCT00328926 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

Sponsor has decided to discontinue Luveris® in the US due to level of customer demand for this product, and not due to any efficacy or safety concerns.

Detailed Description

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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Hypogonadotropic Hypogonadism

Intervention ^ICMJE

Drug: Placebo
Subcutaneous injection once daily until criteria for ovulation triggering is met (21 day max)
Drug: lutropin alfa
Once daily Subcutaneous injection until criteria for ovulation triggering is met (21 day max)
Drug: lutropin alfa
Once daily subcutaneous injection until criteria for ovulation triggering is met (21 day max)

Study Arm (s)

Placebo Comparator: 1
Gonal-f® + a placebo

Intervention: Drug: Placebo
Experimental: 2
Gonal-f® + lutropin alfa 25 IU

Intervention: Drug: lutropin alfa
3
Gonal-f® + lutropin alfa 75 IU

Intervention: Drug: lutropin alfa

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00328926

Other Study ID Numbers ^ICMJE

26109

Has Data Monitoring Committee

Not Provided

Responsible Party

EMD Serono

Study Sponsor ^ICMJE

EMD Serono

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Zourab Bebia, MD

Merck Serono S.A., Geneva

Information Provided By

EMD Serono

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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