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

NCT00328926 | Terminated Phase 4 Results

• 1 other identifier: 26109
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypogonadotropic Hypogonadism

Keywords

Hypogonadotropic Hypogonadism (LH <1.2 IU/L); Placebo; Luveris® 75 IU; Luveris® 25 IU; Recombinant human chorionic gonadotropin (r-hCG)

Outcome Measures

Primary Outcomes (1)

• Time to Clinical Pregnancy

  Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.

  Stimulation Day 1 up to clinical pregnancy (Day 35-42 post r-hCG administration day [end of stimulation cycle {approximately 21 days}])

Secondary Outcomes (2)

• Percentage of Participants With Cumulative Clinical Pregnancy

  Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])

• Percentage of Participants With Cumulative Ovulation

  Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days])

Study Arms (3)

Luveris® 75 IU

ACTIVE COMPARATOR

Drug: Luveris® 75 IU; Drug: Recombinant human follicle stimulating hormone (r-hFSH); Drug: Recombinant human chorionic gonadotropin (r-hCG)

Luveris® 25 IU

ACTIVE COMPARATOR

Drug: Luveris® 25 IU; Drug: Recombinant human follicle stimulating hormone (r-hFSH); Drug: Recombinant human chorionic gonadotropin (r-hCG)

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Recombinant human follicle stimulating hormone (r-hFSH); Drug: Recombinant human chorionic gonadotropin (r-hCG)

Interventions

Luveris® 75 IU DRUG

Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 IU will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and estradiol \[E2\] levels). Total duration will be of 3 treatment cycles.

Also known as: Lutropin alfa, Recombinant human luteinizing hormone (r-hLH)

Luveris® 75 IU

Luveris® 25 IU DRUG

Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.

Also known as: Lutropin alfa, Recombinant human luteinizing hormone (r-hLH)

Luveris® 25 IU

Placebo DRUG

Placebo will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.

Placebo

Recombinant human follicle stimulating hormone (r-hFSH) DRUG

Fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU will be administered subcutaneously for 7 days. After 7 days of treatment, if the subject response will suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.

Also known as: Follitropin alfa

Luveris® 25 IU; Luveris® 75 IU; Placebo

Recombinant human chorionic gonadotropin (r-hCG) DRUG

When the follicular response will adequate, ovulation will be triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.

Also known as: Choriogonadotropin alfa

Luveris® 25 IU; Luveris® 75 IU; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

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)

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (1)

U.S. Medical Information, 1-888-275-7376

Rockland, Massachusetts, 02370, United States

Location

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Hypogonadism

Interventions

Luteinizing Hormone, beta Subunit; Glycoprotein Hormones, alpha Subunit; follitropin alfa; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Follicle Stimulating Hormone; Thyrotropin; Placental Hormones; Pregnancy Proteins; Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Serono S.A., Geneva

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2006
• First Posted: May 24, 2006
• Study Start: March 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 7, 2013
• Results First Posted: July 12, 2013

Record last verified: 2013-08

Locations

US (1)