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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

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

Overview

Status
Terminated
Phase
Phase 4
Enrollment
11 participants (actual)
Sponsor
EMD Serono · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Mar 2006
Primary completion
May 2012
Completion
May 2012
First posted
24 May 2006 (estimated)
Last update posted
7 Aug 2013 (estimated)
Conditions
Hypogonadotropic Hypogonadism

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 4

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

    NCT00328926

    Mar 2006 to May 2012

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Luveris® 75 IUDrug
  • Luveris® 25 IUDrug
  • PlaceboDrug
  • Recombinant human follicle stimulating hormone (r-hFSH)Drug
  • Recombinant human chorionic gonadotropin (r-hCG)Drug

Arms3

  • Active comparator

    Luveris® 75 IU

  • Active comparator

    Luveris® 25 IU

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Clinical Pregnancy

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

    Registry description

    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.

Secondary outcomes(2)
  1. Percentage of Participants With Cumulative Clinical Pregnancy

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

    Registry description

    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. Cumulative clinical pregnancy referred to all clinical pregnancy that occurred during all the 3 treatment cycles.

  2. Percentage of Participants With Cumulative Ovulation

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

    Registry description

    Ovulation was defined as a mid-luteal phase progesterone (P4) level greater than or equal to (\>=) 10 nanogram per milliliter (ng/mL). Cumulative ovulation referred to all ovulations that occurred during all the 3 treatment cycles.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Time to Clinical Pregnancy

GroupValue (Days)
Luveris® 75 IU71
Luveris® 25 IU51
Placebo103
Secondary and other outcome results(2)
Secondary outcomeNumber· Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])

Percentage of Participants With Cumulative Clinical Pregnancy

GroupValue (Percentage of participants)
Luveris® 75 IU60.0
Luveris® 25 IU33.3
Placebo33.3
Secondary outcomeNumber· Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days])

Percentage of Participants With Cumulative Ovulation

GroupValue (Percentage of participants)
Luveris® 75 IU80.0
Luveris® 25 IU33.3
Placebo66.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Luveris® 75 IURecombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.–1 / 54 / 5
Luveris® 25 IURecombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.–0 / 31 / 3
PlaceboPlacebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.–1 / 33 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 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 * 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)

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