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

This study has been completed.
Sponsor:
Collaborator:
Merck Pte. Ltd., Singapore
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01084265
First received: March 4, 2010
Last updated: December 2, 2013
Last verified: December 2013
Results First Received: February 6, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypogonadism
Interventions: Drug: Recombinant human luteinizing hormone (r-hLH)
Drug: Recombinant human follicle-stimulating hormone (r-hFSH)
Drug: Human chorionic gonadotropin (hCG)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Recombinant Human Luteinizing Hormone (Luveris) Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).

Participant Flow:   Overall Study
    Recombinant Human Luteinizing Hormone (Luveris)  
STARTED     31  
COMPLETED     31  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Recombinant Human Luteinizing Hormone (Luveris) Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).

Baseline Measures
    Recombinant Human Luteinizing Hormone (Luveris)  
Number of Participants  
[units: participants]
  30  
Age [1]
[units: years]
Mean ± Standard Deviation
  30.1  ± 4.09  
Gender [1]
[units: participants]
 
Female     30  
Male     0  
[1] Demographic data for only "N = 30" participants was reported as 1 participant did not meet the inclusion criteria.



  Outcome Measures
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1.  Primary:   Number of Participants Who Met Both Index 1 and Index 2   [ Time Frame: Day 14 ]

2.  Primary:   Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter   [ Time Frame: Day 14 ]

3.  Primary:   Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection   [ Time Frame: Day 14 ]

4.  Primary:   Number of Participants Who Refused to Take hCG Injection   [ Time Frame: Day 14 ]

5.  Secondary:   Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle   [ Time Frame: Day 14 ]

6.  Secondary:   Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle   [ Time Frame: Day 14 ]

7.  Secondary:   Average Change of E2 Level in Participants Per Day up to Day 14   [ Time Frame: up to Day 14 ]

8.  Secondary:   Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies   [ Time Frame: Day 14 ]

9.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


No publications provided


Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01084265     History of Changes
Other Study ID Numbers: IMP25345
Study First Received: March 4, 2010
Results First Received: February 6, 2012
Last Updated: December 2, 2013
Health Authority: China: Food and Drug Administration