The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Mbah Anthony Uche, University Of Nigeria Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01409837
First received: August 2, 2011
Last updated: September 21, 2013
Last verified: September 2013
Results First Received: June 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Oligospermia
Intervention: Drug: Lisinopril

  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
As per protocol the recruitment of patients took place from March 1998 to September 2001 while the actual investigation took place from January 2002 to December 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the recruitment period a total of 131 male patients being treated for low sperm count of unknown cause volunteered to participate. They were screened based on the criteria for eligibility as per protocol. Only 33 (25.2%) satisfied the inclusion criteria and were randomized such that 16 were in group A while 17 were in group B.

Reporting Groups
  Description
Group B (Lisinopril First, Then Placebo) Started with Lisinopril 2.5 mg taken once a day. Then crossed over to Sugar Pill taken also once a day. The Lisinopril and the Sugar Pill were made indistinguishable in appearance.
Group A (Placebo First, Then Lisinopril) Started with Sugar Pill taken once daily. Then crossed over to Lisinopril 2.5 mg taken once a day.

Participant Flow:   Overall Study
    Group B (Lisinopril First, Then Placebo)     Group A (Placebo First, Then Lisinopril)  
STARTED     17     16  
6th Week     17     16  
12th Week     16 [1]   16  
24th Week     16     15 [2]
48th Week     15 [3]   15  
96th Week     15     15  
102nd Week     15     14 [4]
114th Week     15     14  
138th Week     15     14  
186th Week     14 [1]   14  
282nd Week     14     14  
COMPLETED     14     14  
NOT COMPLETED     3     2  
Withdrawal by Subject                 2                 1  
Lost to Follow-up                 1                 0  
Physician Decision                 0                 1  
[1] Moved away to another location
[2] Diagnosed with Lymphocytic Lymphoma and withdrawn
[3] Lost to follow-up
[4] Married another wife



  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.
No text entered.

Reporting Groups
  Description
Group B (Lisinopril First, Then Placebo) Started with Lisinopril, crossed over to Placebo
Group A (Placebo First, Then Lisinopril) Started with Sugar Pill, crossed over to Lisinopril
Total Total of all reporting groups

Baseline Measures
    Group B (Lisinopril First, Then Placebo)     Group A (Placebo First, Then Lisinopril)     Total  
Number of Participants  
[units: participants]
  17     16     33  
Age  
[units: Years]
Mean ± Standard Deviation
     
Between 18 and 65 years     30.86  ± 8.8     26.93  ± 7.3     28.895  ± 8.05  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     17     16     33  
Region of Enrollment  
[units: participants]
     
Nigeria     17     16     33  
Height  
[units: metres]
Mean ± Standard Deviation
  1.51  ± 0.4     1.48  ± 0.5     1.495  ± 0.45  
Weight  
[units: Kg]
Mean ± Standard Deviation
  66.19  ± 11.2     64.26  ± 10.3     65.225  ± 10.75  
Duration of infertility  
[units: Years]
Mean ± Standard Deviation
  8.20  ± 4.3     7.77  ± 3.1     7.789  ± 3.7  
Ejaculate volume  
[units: ml]
Geometric Mean ± Standard Deviation
  3.09  ± 0.34     3.01  ± 0.23     3.05  ± 0.29  
Sperm cell count  
[units: Millions/ml]
Geometric Mean ± Standard Deviation
  5.29  ± 2.6     7.43  ± 3.97     6.36  ± 3.29  
Sperm cell motility (%)  
[units: Per┬ácent]
Geometric Mean ± Standard Deviation
  17.33  ± 3.2     22.12  ± 4.4     19.73  ± 3.8  
Sperm cells with abnormal morphology (%)  
[units: Per┬ácent]
Geometric Mean ± Standard Deviation
  42.91  ± 5.1     44.12  ± 2.6     43.52  ± 3.85  



  Outcome Measures
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1.  Primary:   Changes From Baseline in the Seminal Fluid Characteristics Throughout the Study   [ Time Frame: Week 96. ]

2.  Primary:   Total Sperm Cell Count Per Milliliter of Seminal Fluid.   [ Time Frame: Week 96 ]

3.  Primary:   Proportion of Sperm Cells With Normal Motility (%)   [ Time Frame: Week 96 ]

4.  Primary:   Proportion of Sperm Cells With Abnormal Morphology (%)   [ Time Frame: Week 96 ]

5.  Primary:   Ejaculate Volume   [ Time Frame: Week 282 ]

6.  Primary:   Total Sperm Cell Count   [ Time Frame: Week 282 ]

7.  Primary:   Proportion of Sperm Cells With Normal Motility (%)   [ Time Frame: Week 282 ]

8.  Primary:   Proportion of Sperm Cells With Abnormal Morphology (%)   [ Time Frame: Week 282 ]

9.  Secondary:   Adverse Events Monitoring   [ Time Frame: At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282 ]


  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
The sample size of the study is small thereby limiting the reliability of generalizing the findings. In addition, three subjects who started the study terminated prematurely and it is difficult to assess how this fact has affected the study results.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Anthony Mbah, Principal investigator
Organization: University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu
phone: 2348051519065
e-mail: cmd_unth@yahoo.com


Publications:
Mbah AU. Normogonadotrophic, non-obstructive azoospermia: successful treatment of two cases using low-dose lisinopril (Abstract): 24th Annual Scientific Conference of the Association of Physicians of Nigeria. Port Harcourt, 1999.
World Health Organization, WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interactions. 4th ed. Cambridge, United Kingdom: Cambridge University Press; 1999.
39. Lee KC. Fertility treatments and the cost of a healthy baby. Nurs Womens Health. 2011 Feb-Mar;15(1):15-8.
Lee KC. Fertility treatments and the cost of a healthy baby. Nurs Womens Health. 2011 Feb-Mar;15(1):15-8.
Khabibulina MM. [Evaluation of long-term therapy influence with angiotensin converting enzyme inhibitor lisinopril on morphofunctional parameters of the left ventricle, peripheral artery endothelium disfunction and painless myocardial ischemia in premenopausal women with hypertension]. Kardiologiia. 2010;50(1):16-21.
Sangole NV, Dadkar VN. Adverse drug reaction monitoring with angiotensin converting enzyme inhibitors: A prospective, randomized, open-label, comparative study. Indian J Pharmacol. 2010 Feb;42(1):27-31.


Responsible Party: Dr. Mbah Anthony Uche, University Of Nigeria Teaching Hospital
ClinicalTrials.gov Identifier: NCT01409837     History of Changes
Other Study ID Numbers: GHF/GrS/99/S.3
Study First Received: August 2, 2011
Results First Received: June 22, 2013
Last Updated: September 21, 2013
Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control