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

NCT01084265 | Completed Phase 3 Results

• 1 other identifier: IMP25345
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypogonadism

Keywords

Hypogonadism; Recombinant human follicle stimulating hormone (r-hFSH); Recombinant leutinizing hormone (r-hLH)

Outcome Measures

Primary Outcomes (4)

• 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.

  Day 14

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

  Day 14

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

  Day 14

• 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.

  Day 14

Secondary Outcomes (5)

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

  Day 14

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

  Day 14

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

  up to Day 14

• Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies

  Day 14

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

  Day 14

Interventions

Recombinant human luteinizing hormone (r-hLH) DRUG

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

Also known as: Luveris (r-hLH)

Recombinant human follicle-stimulating hormone (r-hFSH) DRUG

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

Also known as: Gonal-F (r-hFSH)

Human chorionic gonadotropin (hCG) DRUG

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Pte. Ltd., Singapore: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Luteinizing Hormone, beta Subunit; Glycoprotein Hormones, alpha Subunit; follitropin alfa; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Follicle Stimulating Hormone; Thyrotropin; Placental Hormones; Pregnancy Proteins; Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Xin Li

  Merck Pte. Ltd., Singapore

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 10, 2010
• Study Start: February 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: December 27, 2013
• Results First Posted: May 22, 2012

Record last verified: 2013-12

Locations

CN (1)