CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Recombinant human luteinizing hormone (r-hLH) +2 moredrug
Likely dose
Recombinant human follicle-stimulating hormone (r-hFSH) 150 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01084265
NCT01084265Phase 3Completed
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Clinical Trial on Application of Injectable Recombinant Human Luteinizing Hormone (Luveris®) in the Treatment of Chinese Female Patients With Hypogonadotropic Hypogonadism: A Multi-center, Open, Prospective Drug Clinical Trial for Registration

Merck KGaA, Darmstadt, Germany·interventional·Posted Mar 10, 2010·Updated Dec 27, 2013

In Brief

A Phase 3 clinical trial evaluating Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH), and 1 other intervention for Hypogonadism. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesChina
CollaboratorsMerck Pte. Ltd., Singapore

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2010
Enrollment StartFeb 1, 2004
Primary CompletionDec 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.3 years ago

Interventions

Recombinant human luteinizing hormone (r-hLH)drug

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

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

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

Human chorionic gonadotropin (hCG)drug

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