Spermicidal Efficacy Of A Vaginal Gel
Condition: Contraception
Study type: Interventional

Summary: 
      There is an urgent need to develop non-hormonal innovative preventive measures under the
      control of women that can prevent unintended pregnancy. Based on our experimental data, the
      use of a gel formulation containing SLS could represent a potent and safe topical vaginal
      spermicide. The impact of such a preventive tool on public health will be enormous. After
      successfully completing supportive Phase I/II safety trials, the next step is a prospective
      pilot clinical trial to evaluate the safety and effectiveness of our gel formulation as a
      spermicidal agent and for preventing unintended pregnancy in healthy women.
    

Detailed description: 
      Study objectives (Outcomes):

      The primary objective (Primary outcome) of this clinical trial is to evaluate the spermicidal
      efficacy in vitro and in post-coital test of gel formulation containing or not 2% SLS, when
      applied once intravaginally in healthy volunteers (women with their stable male sexual
      partners).

      The secondary objective (Secondary outcome) of the study is to evaluate the safety and
      preliminary efficacy in preventing pregnancy of the gel formulation containing 2% SLS when
      used repeatedly before each sexual intercourse for a period of 3 months.

      Study design: Pilot trial First phase- During volunteers screening for eligibility, male
      sexual partners will submit sperm samples; half of the sperm sample will be used for
      spermogram, and the other half of the sperm sample will be used (if normal spermogram) for in
      vitro testing of the spermicidal efficacy of the gel formulation components. If eligible, the
      man and his eligible female sex partner will be enrolled. Eligible women of the eligible male
      sex partners will have one vaginal gel application up to 30 min before planned sexual
      intercourse (vaginal penile penetration) with male ejaculating inside the vagina. Women will
      come to the clinic within a maximum of 12h period after the sexual intercourse for
      post-coital test. The gel must not be applied during menstrual period. The use of other
      vaginal products and male condom by participants is prohibited during the study period. A
      diary will be given to participants to record information concerning the internal use, if
      any, of any vaginal product (including tampons). This pilot trial will be performed in 1
      center at the facilities of the Clinical Research of the CHU de Québec-Université Laval,
      CHUL.

      Second phase- Couples agreeing to use the product repeatedly will continue to use the gel-SLS
      before each and every sexual intercourse, except during menstruation, for a period of 3
      months. Women will report safety parameters after each vaginal use of the gel-SLS and will be
      followed regularly at the facilities of the Clinical Research of the CHU de Québec-Université
      Laval, CHUL.
    

Intervention name(s): vaginal gel containing or not sodium lauryl sulfate
Intervention type(s): Other
Intervention description(s): Prevention
Other intervention name(s): Prevention
Intervention model: Single Group Assignment
Intervention model description: Pilot descriptive study
Masking: None (Open Label)
Primary purpose: Prevention