None listed
Conditions
Interventions
Intervention1: Lactic acid, citric acid, and potassium bitartrate vaginal gel: Each 5 gram dose is provided in a pre-filled single-dose applicator containing lactic acid USP (1.8% w/w), citric acid US
Sponsors
Novitium Pharma a subsidiary of ANI Pharmaceuticals INC
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Endpoint of the study is to compare the spermicidal activity (average percent of spermatozoa motility) of test and reference products. 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. Timepoint: â?¢Endpoint of the study is to compare the spermicidal activity (average percent of spermatozoa motility) of test and reference products. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Senthil Kumar
Scitus Pharma Services Private Limited
Outcome results
None listed