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Ramipril for the Treatment of Oligospermia

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ClinicalTrials.gov Identifier: NCT01856361
Recruitment Status : Terminated (We did not accrue as much as anticipated and the PI (Dabaja) is no longer at Weill Cornell.)
First Posted : May 17, 2013
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Oligospermia
Teratospermia
Asthenozoospermia
Male Infertility
Interventions Drug: Ramipril
Drug: Placebo
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ramipril Placebo
Hide Arm/Group Description

The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.

Ramipril: Angiotensin Converting Enzyme Inhibitor

The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.

Placebo: Placebo pill that will match the treatment pill

Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Ramipril Placebo Total
Hide Arm/Group Description

The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.

Ramipril: Angiotensin Converting Enzyme Inhibitor

The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.

Placebo: Placebo pill that will match the treatment pill

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
2
 100.0%
1.Primary Outcome
Title Sperm Density in Infertile Men With Documented Oligospermia.
Hide Description [Not Specified]
Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.
Arm/Group Title Ramipril Placebo
Hide Arm/Group Description:

The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.

Ramipril: Angiotensin Converting Enzyme Inhibitor

The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.

Placebo: Placebo pill that will match the treatment pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Total Motile Sperm Count(TMSC), Total Sperm Count, Sperm Motility, and Morphology in the Ejaculate.
Hide Description The efficacy of ramipril in improving total sperm count will be evaluated, as well as, improving sperm motility, and morphology.
Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.
Arm/Group Title Ramipril Placebo
Hide Arm/Group Description:

The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.

Ramipril: Angiotensin Converting Enzyme Inhibitor

The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.

Placebo: Placebo pill that will match the treatment pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Pregnancy Rate
Hide Description [Not Specified]
Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.
Arm/Group Title Ramipril Placebo
Hide Arm/Group Description:

The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.

Ramipril: Angiotensin Converting Enzyme Inhibitor

The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.

Placebo: Placebo pill that will match the treatment pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Hormonal Profile
Hide Description LH, FSH, serum testosterone, prolactin
Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.
Arm/Group Title Ramipril Placebo
Hide Arm/Group Description:

The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.

Ramipril: Angiotensin Converting Enzyme Inhibitor

The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.

Placebo: Placebo pill that will match the treatment pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Seminal Angiotensin II and Serum Bradykinin Levels
Hide Description [Not Specified]
Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.
Arm/Group Title Ramipril Placebo
Hide Arm/Group Description:

The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.

Ramipril: Angiotensin Converting Enzyme Inhibitor

The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.

Placebo: Placebo pill that will match the treatment pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ramipril Placebo
Hide Arm/Group Description

The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.

Ramipril: Angiotensin Converting Enzyme Inhibitor

The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.

Placebo: Placebo pill that will match the treatment pill

All-Cause Mortality
Ramipril Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ramipril Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ramipril Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Peter N Schlegel, MD
Organization: Weill Cornell Medical College
Phone: 2127465491
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01856361     History of Changes
Other Study ID Numbers: 1301013462
First Submitted: May 9, 2013
First Posted: May 17, 2013
Results First Submitted: January 13, 2017
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017