Trial Outcomes & Findings for Ramipril for the Treatment of Oligospermia (NCT NCT01856361)

NCT ID: NCT01856361

Last Updated: 2017-06-02

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

32 weeks

Results posted on

2017-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Ramipril 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	Placebo 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 Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ramipril for the Treatment of Oligospermia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramipril n=1 Participants 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	Placebo n=1 Participants 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 n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 32 weeks

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 32 weeks

Population: 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.

The efficacy of ramipril in improving total sperm count will be evaluated, as well as, improving sperm motility, and morphology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 32 weeks

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 32 weeks

Population: 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.

LH, FSH, serum testosterone, prolactin

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 32 weeks

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

Ramipril

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter N Schlegel, MD

Weill Cornell Medical College

Phone: 2127465491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place