<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833115</url>
  </required_header>
  <id_info>
    <org_study_id>CRI-INV.15</org_study_id>
    <nct_id>NCT03833115</nct_id>
  </id_info>
  <brief_title>Spermicidal Efficacy Of A Vaginal Gel</brief_title>
  <official_title>A Pilot Descriptive Study On The Spermicidal Efficacy Of A Vaginal Gel Containing Or Not Sodium Lauryl Sulfate In Healthy Women And Their Male Partners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is an urgent need to develop non-hormonal innovative preventive measures under the&#xD;
      control of women that can prevent unintended pregnancy. Based on our experimental data, the&#xD;
      use of a gel formulation containing SLS could represent a potent and safe topical vaginal&#xD;
      spermicide. The impact of such a preventive tool on public health will be enormous. After&#xD;
      successfully completing supportive Phase I/II safety trials, the next step is a prospective&#xD;
      pilot clinical trial to evaluate the safety and effectiveness of our gel formulation as a&#xD;
      spermicidal agent and for preventing unintended pregnancy in healthy women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study objectives (Outcomes):&#xD;
&#xD;
      The primary objective (Primary outcome) of this clinical trial is to evaluate the spermicidal&#xD;
      efficacy in vitro and in post-coital test of gel formulation containing or not 2% SLS, when&#xD;
      applied once intravaginally in healthy volunteers (women with their stable male sexual&#xD;
      partners).&#xD;
&#xD;
      The secondary objective (Secondary outcome) of the study is to evaluate the safety and&#xD;
      preliminary efficacy in preventing pregnancy of the gel formulation containing 2% SLS when&#xD;
      used repeatedly before each sexual intercourse for a period of 3 months.&#xD;
&#xD;
      Study design: Pilot trial First phase- During volunteers screening for eligibility, male&#xD;
      sexual partners will submit sperm samples; half of the sperm sample will be used for&#xD;
      spermogram, and the other half of the sperm sample will be used (if normal spermogram) for in&#xD;
      vitro testing of the spermicidal efficacy of the gel formulation components. If eligible, the&#xD;
      man and his eligible female sex partner will be enrolled. Eligible women of the eligible male&#xD;
      sex partners will have one vaginal gel application up to 30 min before planned sexual&#xD;
      intercourse (vaginal penile penetration) with male ejaculating inside the vagina. Women will&#xD;
      come to the clinic within a maximum of 12h period after the sexual intercourse for&#xD;
      post-coital test. The gel must not be applied during menstrual period. The use of other&#xD;
      vaginal products and male condom by participants is prohibited during the study period. A&#xD;
      diary will be given to participants to record information concerning the internal use, if&#xD;
      any, of any vaginal product (including tampons). This pilot trial will be performed in 1&#xD;
      center at the facilities of the Clinical Research of the CHU de Québec-Université Laval,&#xD;
      CHUL.&#xD;
&#xD;
      Second phase- Couples agreeing to use the product repeatedly will continue to use the gel-SLS&#xD;
      before each and every sexual intercourse, except during menstruation, for a period of 3&#xD;
      months. Women will report safety parameters after each vaginal use of the gel-SLS and will be&#xD;
      followed regularly at the facilities of the Clinical Research of the CHU de Québec-Université&#xD;
      Laval, CHUL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2018</start_date>
  <completion_date type="Actual">December 4, 2020</completion_date>
  <primary_completion_date type="Actual">December 4, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pilot descriptive study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring motility of spermatozoides in vitro in presence of gel or gel-SLS, and in post-coital test after using gel or gel-SLS</measure>
    <time_frame>3-6 months</time_frame>
    <description>First, the motility of spermatozoides (progressive, non-progressive, or non-motile) in vitro in presence of gel, gel-SLS will be measured.&#xD;
Second, the motility of spermatozoides in post-coital test after single intravaginal application of gel or gel-SLS will be measured in women.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recording pregnancy occurrence after using gel-SLS</measure>
    <time_frame>3 months</time_frame>
    <description>Recording pregnancy (no. of pregnant women) after the intravaginal application of the gel-SLS before each sexual intercourse for a period of 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recording adverse events (AE) after using gel-SLS</measure>
    <time_frame>3 months</time_frame>
    <description>Recording AE (general and genital AE) after the intravaginal application of the gel-SLS before each sexual intercourse for a period of 3 months.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>vaginal gel containing sodium lauryl sulfate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>vaginal gel containing or not sodium lauryl sulfate</intervention_name>
    <description>Prevention</description>
    <arm_group_label>vaginal gel containing sodium lauryl sulfate</arm_group_label>
    <other_name>Prevention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Woman&#xD;
&#xD;
          1. Healthy woman seeking to space or delay pregnancy aged between 18 and 49 years&#xD;
&#xD;
          2. Sexually active&#xD;
&#xD;
          3. Willing to give written informed consent to participate in the trial&#xD;
&#xD;
          4. Normal physical and gynecological examination&#xD;
&#xD;
          5. Negative urine pregnancy test at screening&#xD;
&#xD;
          6. Willing to engage in planned heterosexual vaginal intercourse with ejaculation inside&#xD;
             the vagina&#xD;
&#xD;
          7. Female participant in first phase of the study must be already using and agreeing&#xD;
             continuous use of a reliable method of contraception defined as use of hormonal&#xD;
             contraception (pill, patch or injection, in accordance with the approved product&#xD;
             label) during treatment with the study product and must agree to maintain the&#xD;
             contraceptive method for at least 2 weeks after discontinuation of study product if&#xD;
             not participating in second phase of the study. If the female participant participates&#xD;
             in the second phase of the study, she must stop using the method of contraception&#xD;
             during product application and use only the test product provided (vaginal gel-SLS).&#xD;
&#xD;
        Man&#xD;
&#xD;
          1. Healthy man aged 18 years and older&#xD;
&#xD;
          2. Sexually active&#xD;
&#xD;
          3. Normal spermogram at inclusion&#xD;
&#xD;
          4. Normal physical examination&#xD;
&#xD;
          5. Willing to give written informed consent to participate in the trial&#xD;
&#xD;
          6. Willing to engage in planned heterosexual vaginal intercourse with ejaculation inside&#xD;
             the vagina for post coital test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Woman&#xD;
&#xD;
          1. Abnormal physical/gynecological examination&#xD;
&#xD;
          2. Pregnant at enrolment&#xD;
&#xD;
          3. Lactating or breastfeeding&#xD;
&#xD;
          4. History of vaginitis during the last 3 months&#xD;
&#xD;
          5. History of using vaginal medications during the last 3 months&#xD;
&#xD;
          6. History of STIs (genital herpes, HIV, gonorrhea, chlamydiasis, syphilis, vulvo-vaginal&#xD;
             or cervical HPV) during the last 12 months&#xD;
&#xD;
          7. STIs at time of screening&#xD;
&#xD;
          8. Abnormal laboratory findings with clinical significance&#xD;
&#xD;
          9. Allergy to applicator material (polyethylene), to gel polymer&#xD;
             (polyoxyethylene-polyoxypropylene)&#xD;
&#xD;
         10. History of toxic shock syndrome (TSS)&#xD;
&#xD;
         11. Use of other contraceptive methods during the study period other than the ones&#xD;
             accepted in the study including intrauterine device (IUD), diaphragm, spermicide,&#xD;
             contraceptive ring and fertility awareness methods (first phase of the study, no&#xD;
             contraception during the second phase)&#xD;
&#xD;
         12. Post-menopausal (12 months of spontaneous amenorrhea and ≥40 years of age) or&#xD;
             physically incapable of becoming pregnant with documented permanent sterilization or&#xD;
             history of infertility without anterior pregnancy.&#xD;
&#xD;
         13. Women seeking for efficient contraception&#xD;
&#xD;
         14. Current enrolment in any other clinical trial involving investigational drug, vaccine&#xD;
             or medical device.&#xD;
&#xD;
         15. Any condition for which, in the opinion of the investigator, participation would not&#xD;
             be in the best interest of the participant or that could prevent, limit, or confound&#xD;
             the protocol specified assessments.&#xD;
&#xD;
        Man&#xD;
&#xD;
          1. Abnormal physical examination&#xD;
&#xD;
          2. Abnormal spermogram&#xD;
&#xD;
          3. Surgical sterilization&#xD;
&#xD;
          4. History of urinary infections during the last 3 months&#xD;
&#xD;
          5. History of STIs (genital herpes, HIV, gonorrhea, chlamydiasis, syphilis, HPV) during&#xD;
             the last 12 months&#xD;
&#xD;
          6. STIs at time of screening&#xD;
&#xD;
          7. Abnormal laboratory findings with clinical significance&#xD;
&#xD;
          8. Allergy to gel polymer (polyoxyethylene-polyoxypropylene)&#xD;
&#xD;
          9. Current enrolment in any other clinical trial involving investigational drug, vaccine&#xD;
             or medical device.&#xD;
&#xD;
         10. Any condition for which, in the opinion of the investigator, participation would not&#xD;
             be in the best interest of the participant or that could prevent, limit, or confound&#xD;
             the protocol specified assessments.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>vaginal product for women and their male sexual partners</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Michel Bergeron</name>
      <address>
        <city>Quebec</city>
        <zip>G1V4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Michel G. Bergeron, MD FRCPC</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833115
org study id: CRI-INV.15
nct id: NCT03833115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilot descriptive study
primary purpose: Prevention
masking: None (Open Label)
measure: Measuring motility of spermatozoides in vitro in presence of gel or gel-SLS, and in post-coital test after using gel or gel-SLS
time frame: 3-6 months
description: First, the motility of spermatozoides (progressive, non-progressive, or non-motile) in vitro in presence of gel, gel-SLS will be measured.
Second, the motility of spermatozoides in post-coital test after single intravaginal application of gel or gel-SLS will be measured in women.
measure: Recording pregnancy occurrence after using gel-SLS
time frame: 3 months
description: Recording pregnancy (no. of pregnant women) after the intravaginal application of the gel-SLS before each sexual intercourse for a period of 3 months.
measure: Recording adverse events (AE) after using gel-SLS
time frame: 3 months
description: Recording AE (general and genital AE) after the intravaginal application of the gel-SLS before each sexual intercourse for a period of 3 months.
arm group label: vaginal gel containing sodium lauryl sulfate
arm group type: Experimental
intervention type: Other
intervention name: vaginal gel containing or not sodium lauryl sulfate
description: Prevention
arm group label: vaginal gel containing sodium lauryl sulfate
other name: Prevention
criteria: 
gender: Female
gender based: Yes
gender description: vaginal product for women and their male sexual partners
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Michel G. Bergeron, MD FRCPC
investigator title: Professor