Ex-Vivo Study of Comparing Spermicidal Activity of Lactic Acid, Citric Acid, And Potassium Bitartrate Vaginal Gel (Test & Reference Product) on Semen Sample

Not Applicable

Completed

• Registration Number: CTRI/2023/03/050633
• Lead Sponsor: ovitium Pharma a subsidiary of ANI Pharmaceuticals INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Adult, human male volunteers of aged 18 years and older.

Volunteer who are able to communicate effectively and provide written informed consent.

Normal physical examination.

Volunteer willing to adhere the requirements of Seminogram or Spermiogram test (sperm concentration, progressive motility, total sperm count in ejaculate, sperm morphology).

Volunteer with no HIV and VDRL infection and/or not been diagnosed with in last 06 months.

Volunteers who had not donated semen / sexual intercourse / masturbation for past 03 days.

Note: Average motile spermatozoa should be >= 60%.

Exclusion Criteria

Surgical sterilization

History and presence of urinary tract infections.

History of HIV and VDRL during the last 06 months.

Abnormal laboratory findings with clinical significance.

Current enrolment in any other clinical trial involving investigational drug, vaccine or medical device.

Participation in a research study and/or donation of semen samples within 03 months.

Any condition for which, in the opinion of the medical monitor, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol specified assessments

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Endpoint of the study is to compare the spermicidal activity (average percent of spermatozoa motility) of test and reference products. <br/ ><br>â?¢All data will be adjusted to a control (semen only) motile fraction for each experiment to permit comparison of data. Spermicidal activity of test and reference formulation will be compared. <br/ ><br>Timepoint: â?¢Endpoint of the study is to compare the spermicidal activity (average percent of spermatozoa motility) of test and reference products. <br/ ><br>â?¢All data will be adjusted to a control (semen only) motile fraction for each experiment to permit comparison of data. Spermicidal activity of test and reference formulation will be compared. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
ot ApplicableTimepoint: Not Applicable