SPL7013 Gel - Male Tolerance Study

Phase 1

Completed

• Conditions: Safety for HIV preventive product; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12606000385549
• Lead Sponsor: Starpharma Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

1.Provision of written informed consent. 2.HIV negative as documented by licensed ELISA at Screening. 3.Agree to abstain from vaginal, anal (receptive and insertive) and oral sexual intercourse until after the End-of-Treatment (Day 7) study visit. 4.Has reported vaginal intercourse occurring in the past 12 months.

Exclusion Criteria

1.Known or suspected allergy to any component of the study products or similar ingredients in other products. 2.History of significant drug reaction or allergy. 3.Recent history (within 12 months) or presence at screening of contact dermatitis or other dermatological condition. 4.Recent history (within three months of Screening) of a sexually transmitted infection (STI). 5.Current signs or symptoms of urinary tract infection (UTI) and/or STI at Screening or Baseline. 6.Positive urine leukocyte esterase test (= trace). 7.Biochemical and/or haematological parameters outside the laboratory's normal reference ranges at Screening. 8.Evidence of genital piercing, ulceration, genital dermatoses, tinea cruris or other dermatological condition of the genitalia or upper thighs. 9.Genital pain or discomfort at Screening or Baseline. 10.Any other abnormal finding on physical examination or other medical condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified