A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Recombinant human luteinizing hormone (r-hLH); Recombinant human follicle-stimulating hormone (r-hFSH); Human chorionic gonadotropin (hCG)
Intervention description: One r-hLH (75 International Units [IU]) injection s.c. once daily.; One r-hFSH (150 IU) injection s.c. once daily.; After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG.
Intervention MeSH terms: Chorionic Gonadotropin; Hormones; Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Healthy volunteers: No
Keywords: Hypogonadism; Recombinant human follicle stimulating hormone (r-hFSH); Recombinant leutinizing hormone (r-hLH)

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

          -  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

        Exclusion Criteria:

          -  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

          -  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