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AzTrials

HypogonadismPhase 3NCT01084265

A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism

A Phase 3 study testing Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH) and Human chorionic gonadotropin (hCG) in people with Hypogonadism, run by Merck KGaA, Darmstadt, Germany at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Hypogonadism
What is being tested?
Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH) and Human chorionic gonadotropin (hCG)
Type of treatment
Injection or infusion
How many people
31 participants
Where
1 siteChina
Study dates
Feb 2004to Dec 2005
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Be premenopausal, between 18 and 39 years of age
  • Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism during screening procedure
  • Have discontinued gonadotropins, gonadotropin-releasing hormone (GnRH) (gonadotropin naïve), or estrogen progesterone replacement therapy at least one month before the screening procedure
  • Have a negative progestin challenge test performed during screening
  • Have the following hormonal values in a centrally analyzed fasting blood sample, drawn within 6 months before initiation of treatment:
  • Follicular stimulating hormone (FSH): < 5 international units/liter (IU/L)
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  • Luteinizing hormone (LH): < 1.2 IU/L
  • Oestradiol (E2): < 60 picogram/milliliter (pg/mL) (<220 picomolar/liter [pmol/L])
  • Prolactin (PRL): < 44.3 nanogram/milliliter (ng/mL) (< 1040 milli-international units/liter [mIU/L])
  • Thyrotrophin-stimulating hormone (TSH): < 6.5 micro-international units (uIU/mL)
  • Free Thyroxine (T4): 0.8-1.8 nanogram/deciliter (ng/dL) (11-24 pmol/L)
  • Triiodothyronine (T3): < 1.0 ng/mL (< 3.5 nanomolar/liter [nmol/L])
  • Have an endovaginal pelvic ultrasound scan showing (i) no ovarian tumor and cyst < 2 centimeters (cm); (ii) no clinically significant uterine abnormality, and (iii) < 13 mm 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
  • Have a body mass index (BMI) between 18.4 and 31.4 kilogram/meter square (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

Who cannot join

  • Ongoing pregnancy
  • Any chronic systemic disease
  • Hypersensitive to study drug and control drug
  • History of severe ovarian hyperstimulation syndrome
  • Abnormal gynecological bleeding of undetermined origin
  • Previous or current hormone dependent tumor
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  • 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, the subject will not be eligible without consulting Serono's Medical Director
  • Exercise program exceeding 10 hours per week
  • Currently undergoing treatment with psychotropic medication or with any other medication known to interfere with normal reproductive function (for example, neuroleptics, dopamine antagonists)
  • There is any abnormality, decided by investigators, which might produce effect on the absorption, distribution and excretion of investigational drug

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, 100730

Other trials in China

About this study

Official title: Clinical Trial on Application of Injectable Recombinant Human Luteinizing Hormone (Luveris®) in the Treatment of Chinese Female Patients With Hypogonadotropic Hypogonadism: A Multi-center, Open, Prospective Drug Clinical Trial for Registration

This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism.

Read the detailed description

The objective of this prospective, open, non-comparative study was to assess the safety and efficacy of rhLH (Luveris) administered subcutaneously in follicular development during ovulation induction in Chinese female subjects with hypogonadotropic hypogonadism. The study was organized on an outpatient basis involving a single cycle of treatment. Prior to entry into the study, the diagnosis of hypogonadotropic hypogonadism was confirmed by history, by the presence or absence of specific clinical features and by measuring serum gonadotropin levels. Once a subject has signed the informed consent form and after satisfying all eligibility criteria, the subject received a combination of daily injection of recombinant human follicle-stimulating hormone (rhFSH) 150 international units (IU) plus rhLH 75 IU. After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU human chorionic gonadotropin (hCG). Luteal phase function was assessed by serum progesterone level determination.

Conditions
Hypogonadism
Being tested
Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH), Human chorionic gonadotropin (hCG)
Keywords
Hypogonadism, Recombinant human follicle stimulating hormone (r-hFSH), Recombinant leutinizing hormone (r-hLH)
Medical subject headings
Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant human luteinizing hormone (r-hLH)Drug

    Also called Luveris (r-hLH)

    One r-hLH (75 International Units [IU]) injection s.c. once daily.

  • Recombinant human follicle-stimulating hormone (r-hFSH)Drug

    Also called Gonal-F (r-hFSH)

    One r-hFSH (150 IU) injection s.c. once daily.

  • Human chorionic gonadotropin (hCG)Drug

    After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Met Both Index 1 and Index 2

    The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.

    Measured: Day 14

  2. Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter

    Measured: Day 14

  3. Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection

    Measured: Day 14

  4. Number of Participants Who Refused to Take hCG Injection

    Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.

    Measured: Day 14

Secondary outcomes (5)

  1. Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle

    Measured: Day 14

  2. Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle

    Measured: Day 14

  3. Average Change of E2 Level in Participants Per Day up to Day 14

    The average change was calculated by assessing the E2 levels on 4 timepoints until day 14 (day 1, day 5, day 10, day 14 [hCG administration day]).

    Measured: up to Day 14

  4. Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies

    Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Clinical pregnancy was defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.

    Measured: Day 14

  5. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.

    Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2010 (estimated)
  2. Study startFeb 2004
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01084265
Sponsor's protocol ID
IMP25345
Status last verified
Dec 2013
First submitted
4 Mar 2010
Last updated
27 Dec 2013

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH) and Human chorionic gonadotropin (hCG) in people with Hypogonadism, run by Merck KGaA, Darmstadt, Germany at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Met Both Index 1 and Index 2 (time frame: Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01084265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2013.

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