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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Pte. Ltd., Singapore
• Treatments: Chorionic Gonadotropin; Follicle Stimulating Hormone; Hormones

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