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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Hypogonadism

Treatments

Drug: Recombinant human luteinizing hormone (r-hLH)

Drug: Human chorionic gonadotropin (hCG)

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01084265

IMP25345

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

Female

Volunteers

No Healthy Volunteers

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