MedTrace Logo

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

NCT01084265 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2013-12-27

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Recombinant human luteinizing hormone (r-hLH)

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

DRUG

Recombinant human follicle-stimulating hormone (r-hFSH)

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

DRUG

Human chorionic gonadotropin (hCG)

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

Sponsors & Collaborators

  • Merck Pte. Ltd., Singapore

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Xin Li · Merck Pte. Ltd., Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084265 on ClinicalTrials.gov