<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/NCT02994602</url>
  </required_header>
  <id_info>
    <org_study_id>CCN005B</org_study_id>
    <secondary_id>HHSN275201200002I</secondary_id>
    <nct_id>NCT02994602</nct_id>
  </id_info>
  <brief_title>Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males</brief_title>
  <acronym>CCN005B</acronym>
  <official_title>An Open-Label Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males: Effect of Washing or Clothing Barrier to the Application</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Decisions</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Population Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Health Decisions</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two-center, open-label study conducted in healthy male and female volunteers at two&#xD;
      academic research centers. The study will consist of three single applications of the&#xD;
      Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male&#xD;
      participants followed 2 hours later by supervised skin contact by the non-dosed female&#xD;
      participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing&#xD;
      Barrier to the Application will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-center, open-label study conducted in healthy male and female volunteers at two&#xD;
      academic research centers. The study will consist of three single applications of the&#xD;
      Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male&#xD;
      participants followed 2 hours later by supervised skin contact by the non-dosed female&#xD;
      participants on the application site on days 1, 8, and 15.&#xD;
&#xD;
      On day 1, the male participant will wear a 100% cotton T-shirt over the application area&#xD;
      before skin contact with the female.&#xD;
&#xD;
      On day 8, the male participant will shower approximately 1 hour and 45 minutes after gel&#xD;
      application and engage in skin contact with the female participant (2 hours after gel&#xD;
      application) after washing the area with soap and water then drying it. A measurement of&#xD;
      residual Nestorone and testosterone will be taken from the male's skin on a single location&#xD;
      of the application site using adhesive D-square strips 90 minutes after application (30&#xD;
      minutes before shower/90 minutes after gel application) and 30 minutes after the shower and&#xD;
      rubbing (150 minutes after application).&#xD;
&#xD;
      On day 15, there will be no shower or clothing barrier for the male participant before skin&#xD;
      contact with the female participant. A measurement of residual Nestorone and testosterone&#xD;
      will be taken from a single location of the application using adhesive D-square strips site&#xD;
      90 minutes and 150 minutes after the application.&#xD;
&#xD;
      An end of study/exit visit will occur for both male and female participants two weeks after&#xD;
      treatment completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel</measure>
    <time_frame>17 days</time_frame>
    <description>female serum testosterone changes in cavg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel</measure>
    <time_frame>17 days</time_frame>
    <description>female serum testosterone changes in cmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel</measure>
    <time_frame>17 days</time_frame>
    <description>female serum testosterone changes in cmin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cavg</measure>
    <time_frame>17 days</time_frame>
    <description>female nestorone levels in cavg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cmax</measure>
    <time_frame>17 days</time_frame>
    <description>female nestorone levels in cmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cmin</measure>
    <time_frame>17 days</time_frame>
    <description>female nestorone levels in cmin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK of testosterone in males after wearing a T shirt and after washing will be compared to serum testosterone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration)</measure>
    <time_frame>15 days</time_frame>
    <description>PK of T in males after NES/T with a T-shirt and after washing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK of Nestorone in males after wearing a T shirt and after washing will be compared to serum Nestorone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration)</measure>
    <time_frame>15 days</time_frame>
    <description>PK of NES in males after NES/T with a T-shirt and after washing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK of serum testosterone in males after applying NES/T gel with or without T shirt and with washing will be compared to baseline serum testosterone</measure>
    <time_frame>15 days</time_frame>
    <description>male changes in serum T compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average testosterone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with and without showering.</measure>
    <time_frame>15 days</time_frame>
    <description>T levels compared with and without showering</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Nestorone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with and without showering.</measure>
    <time_frame>15 days</time_frame>
    <description>NES levels compared with and without showering</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events and serious adverse events for males</measure>
    <time_frame>31 days</time_frame>
    <description>Male AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events and serious adverse events for females</measure>
    <time_frame>31 days</time_frame>
    <description>Female AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in safety labs for males</measure>
    <time_frame>15 days</time_frame>
    <description>Male lab changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in safety labs for males</measure>
    <time_frame>31 days</time_frame>
    <description>Female lab changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of females with increased (relative to baseline) hirsutism at each visit.</measure>
    <time_frame>31 days</time_frame>
    <description>Female hirsutism changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of females with increased (relative to baseline) acne at each visit.</measure>
    <time_frame>31 days</time_frame>
    <description>Female acne changes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Men</condition>
  <condition>Male Contraception</condition>
  <condition>Healthy Women</condition>
  <condition>Product Transference</condition>
  <arm_group>
    <arm_group_label>Nestorone (NES) + testosterone (T) combined gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nestorone + Testosterone Combination Gel</intervention_name>
    <description>The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).</description>
    <arm_group_label>Nestorone (NES) + testosterone (T) combined gel</arm_group_label>
    <other_name>NES/T gel</other_name>
    <other_name>NES8/T60</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Male participant - Inclusion Criteria&#xD;
&#xD;
        Men who meet all the following criteria will be eligible for enrollment in the trial:&#xD;
&#xD;
          1. Good health as confirmed by medical history, physical examination, and clinical&#xD;
             laboratory tests of blood and urine at the time of screening;&#xD;
&#xD;
          2. 18 to 50 years of age;&#xD;
&#xD;
          3. BMI ≥ 18 and &lt; 35 kg/m2;&#xD;
&#xD;
          4. No history of androgen use prior to the first screening visit as follows:&#xD;
&#xD;
               1. 1 month prior for oral or transdermal androgen,&#xD;
&#xD;
               2. 3 months prior for Testosterone cypionate or enanthate injection,&#xD;
&#xD;
               3. 6 months prior for Testosterone undecanoate injection;&#xD;
&#xD;
          5. Agreement to use a recognized effective method of short acting contraception with his&#xD;
             partner (i.e. at a minimum use double-barrier method such as a condom with spermicide)&#xD;
             during the entire study;&#xD;
&#xD;
          6. In the opinion of the investigator, male subject is willing and able to comply with&#xD;
             the protocol;&#xD;
&#xD;
          7. Provision of valid, written and informed consent.&#xD;
&#xD;
        Female participant - Inclusion Criteria&#xD;
&#xD;
        Women who meet all the following criteria will be eligible for enrollment in the trial:&#xD;
&#xD;
          1. Good general health (BMI ≥18 and &lt;30 kg/m2)with no chronic medical conditions that&#xD;
             result in periodic exacerbations which require significant medical care;&#xD;
&#xD;
          2. Aged between 18 and 40 years, at the enrollment visit;&#xD;
&#xD;
          3. Not pregnant and not breastfeeding.&#xD;
&#xD;
          4. Agreement to use a recognized effective method of contraception throughout the study&#xD;
&#xD;
          5. Willingness and ability to provide valid, written and informed consent and to comply&#xD;
             with the protocol;&#xD;
&#xD;
          6. No desire for pregnancy within the next 6 months.&#xD;
&#xD;
        Exclusion Male participant - Exclusion Criteria&#xD;
&#xD;
        Men who meet any of the following criteria are not eligible for enrollment in the trial:&#xD;
&#xD;
          1. Men participating in another clinical trial involving an investigational drug within&#xD;
             the last 30 days prior to the first screening visit.&#xD;
&#xD;
          2. Men not living in the catchment area of the study site or within a reasonable travel&#xD;
             time from the site.&#xD;
&#xD;
          3. Any clinically significant abnormal findings at screening per the Investigator's&#xD;
             medical judgement.&#xD;
&#xD;
          4. Elevated PSA (e.g. levels ≥ 4 ng/mL), according to study site's local laboratory&#xD;
             reference normal values for adult men.&#xD;
&#xD;
          5. Abnormal serum chemistry values that may indicate clinically significant liver or&#xD;
             kidney dysfunction. Other abnormal laboratory values may also be exclusionary, if so&#xD;
             considered by the investigator to be clinically significant.&#xD;
&#xD;
          6. Use of androgens or other anabolic steroids that may affect testosterone measurements&#xD;
&#xD;
          7. Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP&#xD;
             will be taken three times at approximately 5 minute intervals and the mean of the 3&#xD;
             measurements will be considered).&#xD;
&#xD;
          8. History of hypertension (well-controlled treated hypertension (&lt; 135/85) is allowed).&#xD;
&#xD;
          9. Known history of primary testicular disease or disorders of the hypothalamic-pituitary&#xD;
             axis.&#xD;
&#xD;
         10. Known hypersensitivity to progestins or testosterone.&#xD;
&#xD;
         11. History of prostate or breast carcinoma&#xD;
&#xD;
         12. Significant lower urinary obstructive symptoms (IPSS &gt; 19).&#xD;
&#xD;
         13. Known history of significant cardiac, renal, hepatic or prostatic disease.&#xD;
&#xD;
         14. History of thromboembolic disease.&#xD;
&#xD;
         15. A serious systemic disease such as diabetes mellitus (including diabetes controlled&#xD;
             with treatment), HIV, or morbid obesity.&#xD;
&#xD;
         16. Current active or ongoing Hepatitis infection&#xD;
&#xD;
         17. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any&#xD;
             illicit drug use that may affect metabolism/transformation of steroid hormones and&#xD;
             study treatment compliance.&#xD;
&#xD;
         18. Known active or chronic dermatitis or other severe skin disorder.&#xD;
&#xD;
         19. Desiring fertility within 6 months of study participation.&#xD;
&#xD;
         20. History of severe depression or other serious mental health disorder.&#xD;
&#xD;
         21. Men participating in competitive sports where drug screening for prohibited substances&#xD;
             (including anabolic steroids) is routine will be advised of the relative and temporary&#xD;
             hazards that participating in this study may have for their sporting status.&#xD;
&#xD;
        Female participant - Exclusion Criteria&#xD;
&#xD;
        Women who meet any of the following criteria are not eligible for enrollment in the trial:&#xD;
&#xD;
          1. Desire to become pregnant during the study.&#xD;
&#xD;
          2. Breastfeeding&#xD;
&#xD;
          3. Known or suspected current alcoholism or drug abuse.&#xD;
&#xD;
          4. History of thrombosis&#xD;
&#xD;
          5. Serum testosterone outside normal reference ranges by local laboratory standards or&#xD;
             evidence of hirsutism (modified Ferriman-Galwey score &gt; 8)&#xD;
&#xD;
          6. Participation in another clinical trial involving an investigational drug within the&#xD;
             last 30 days prior to the first screening visit.&#xD;
&#xD;
          7. Current pregnancy.&#xD;
&#xD;
          8. Known hypersensitivity to progestins or testosterone.&#xD;
&#xD;
          9. Any clinically significant abnormal findings at screening per the Investigator's&#xD;
             medical judgement.&#xD;
&#xD;
         10. Use of androgens or other anabolic steroids that may affect testosterone measurements.&#xD;
&#xD;
         11. Known active or chronic dermatitis or other severe skin disorder.&#xD;
&#xD;
         12. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any&#xD;
             illicit drug use that may affect metabolism/transformation of steroid hormones and&#xD;
             study treatment compliance.&#xD;
&#xD;
         13. Not living in the catchment area of the study site or within a reasonable travel time&#xD;
             from the site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bradley Anawalt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center &amp; Health Sciences</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  </reference>
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    <PMID>14667989</PMID>
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    <citation>Rolf C, Knie U, Lemmnitz G, Nieschlag E. Interpersonal testosterone transfer after topical application of a newly developed testosterone gel preparation. Clin Endocrinol (Oxf). 2002 May;56(5):637-41. doi: 10.1046/j.1365-2265.2002.01529.x.</citation>
    <PMID>12030915</PMID>
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  <reference>
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    <PMID>18801940</PMID>
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    <PMID>2642780</PMID>
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  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Men</keyword>
  <keyword>Male Contraception</keyword>
  <keyword>Healthy Women</keyword>
  <keyword>Transfer</keyword>
  <keyword>Transference</keyword>
  <keyword>Gel</keyword>
  <keyword>Nestorone</keyword>
  <keyword>Testosterone</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>ST 1435</mesh_term>
    <mesh_term>Testosterone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02994602
org study id: CCN005B
secondary id: HHSN275201200002I
nct id: NCT02994602
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This is a two-center, open-label study conducted in healthy male and female volunteers at two
      academic research centers. The study will consist of three single applications of the
      Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male
      participants followed 2 hours later by supervised skin contact by the non-dosed female
      participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing
      Barrier to the Application will be assessed.
This is a two-center, open-label study conducted in healthy male and female volunteers at two
      academic research centers. The study will consist of three single applications of the
      Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male
      participants followed 2 hours later by supervised skin contact by the non-dosed female
      participants on the application site on days 1, 8, and 15.

      On day 1, the male participant will wear a 100% cotton T-shirt over the application area
      before skin contact with the female.

      On day 8, the male participant will shower approximately 1 hour and 45 minutes after gel
      application and engage in skin contact with the female participant (2 hours after gel
      application) after washing the area with soap and water then drying it. A measurement of
      residual Nestorone and testosterone will be taken from the male's skin on a single location
      of the application site using adhesive D-square strips 90 minutes after application (30
      minutes before shower/90 minutes after gel application) and 30 minutes after the shower and
      rubbing (150 minutes after application).

      On day 15, there will be no shower or clothing barrier for the male participant before skin
      contact with the female participant. A measurement of residual Nestorone and testosterone
      will be taken from a single location of the application using adhesive D-square strips site
      90 minutes and 150 minutes after the application.

      An end of study/exit visit will occur for both male and female participants two weeks after
      treatment completion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel
time frame: 17 days
description: female serum testosterone changes in cavg
measure: Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel
time frame: 17 days
description: female serum testosterone changes in cmax
measure: Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel
time frame: 17 days
description: female serum testosterone changes in cmin
measure: Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cavg
time frame: 17 days
description: female nestorone levels in cavg
measure: Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cmax
time frame: 17 days
description: female nestorone levels in cmax
measure: Evaluate in female participants by assessing Nestorone levels after secondary exposure to NES/T by presenting Cmin
time frame: 17 days
description: female nestorone levels in cmin
measure: PK of testosterone in males after wearing a T shirt and after washing will be compared to serum testosterone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration)
time frame: 15 days
description: PK of T in males after NES/T with a T-shirt and after washing
measure: PK of Nestorone in males after wearing a T shirt and after washing will be compared to serum Nestorone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration)
time frame: 15 days
description: PK of NES in males after NES/T with a T-shirt and after washing
measure: PK of serum testosterone in males after applying NES/T gel with or without T shirt and with washing will be compared to baseline serum testosterone
time frame: 15 days
description: male changes in serum T compared to baseline
measure: Average testosterone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with and without showering.
time frame: 15 days
description: T levels compared with and without showering
measure: Average Nestorone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with and without showering.
time frame: 15 days
description: NES levels compared with and without showering
measure: Incidence of adverse events and serious adverse events for males
time frame: 31 days
description: Male AEs
measure: Incidence of adverse events and serious adverse events for females
time frame: 31 days
description: Female AEs
measure: Changes from baseline in safety labs for males
time frame: 15 days
description: Male lab changes
measure: Changes from baseline in safety labs for males
time frame: 31 days
description: Female lab changes
measure: Percentage of females with increased (relative to baseline) hirsutism at each visit.
time frame: 31 days
description: Female hirsutism changes
measure: Percentage of females with increased (relative to baseline) acne at each visit.
time frame: 31 days
description: Female acne changes
arm group label: Nestorone (NES) + testosterone (T) combined gel
arm group type: Experimental
description: A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel.
intervention type: Drug
intervention name: Nestorone + Testosterone Combination Gel
description: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
arm group label: Nestorone (NES) + testosterone (T) combined gel
other name: NES/T gel
other name: NES8/T60
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christina Wang, MD
role: Principal Investigator
affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
last name: Bradley Anawalt, MD
role: Principal Investigator
affiliation: University of Washington
facility: 
facility: 
country: United States
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PMID: 10386821
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PMID: 18061700
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citation: Ilani N, Roth MY, Amory JK, Swerdloff RS, Dart C, Page ST, Bremner WJ, Sitruk-Ware R, Kumar N, Blithe DL, Wang C. A new combination of testosterone and nestorone transdermal gels for male hormonal contraception. J Clin Endocrinol Metab. 2012 Oct;97(10):3476-86. doi: 10.1210/jc.2012-1384. Epub 2012 Jul 12.
PMID: 22791756
citation: Kamischke A, Ploger D, Venherm S, von Eckardstein S, von Eckardstein A, Nieschlag E. Intramuscular testosterone undecanoate with or without oral levonorgestrel: a randomized placebo-controlled feasibility study for male contraception. Clin Endocrinol (Oxf). 2000 Jul;53(1):43-52. doi: 10.1046/j.1365-2265.2000.01024.x. Erratum In: Clin Endocrinol (Oxf) 2000 Nov;53(5):661.
PMID: 10931079
citation: Knuth UA, Yeung CH, Nieschlag E. Combination of 19-nortestosterone-hexyloxyphenylpropionate (Anadur) and depot-medroxyprogesterone-acetate (Clinovir) for male contraception. Fertil Steril. 1989 Jun;51(6):1011-8. doi: 10.1016/s0015-0282(16)60735-5.
PMID: 2524404
citation: Kumar N, Koide SS, Tsong Y, Sundaram K. Nestorone: a progestin with a unique pharmacological profile. Steroids. 2000 Oct-Nov;65(10-11):629-36. doi: 10.1016/s0039-128x(00)00119-7.
PMID: 11108869
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PMID: 15231947
citation: Laurikka-Routti M, Haukkamaa M, Heikinheimo O. A contraceptive vaginal ring releasing ethinyl estradiol and the progestin ST-1435: bleeding control, serum steroid concentrations, serum lipids and serum chemistry. Contraception. 1990 Jul;42(1):111-20. doi: 10.1016/0010-7824(90)90095-d.
PMID: 2387151
citation: Mahabadi V, Amory JK, Swerdloff RS, Bremner WJ, Page ST, Sitruk-Ware R, Christensen PD, Kumar N, Tsong YY, Blithe D, Wang C. Combined transdermal testosterone gel and the progestin nestorone suppresses serum gonadotropins in men. J Clin Endocrinol Metab. 2009 Jul;94(7):2313-20. doi: 10.1210/jc.2008-2604. Epub 2009 Apr 14.
PMID: 19366848
citation: Martin CW, Anderson RA, Cheng L, Ho PC, van der Spuy Z, Smith KB, Glasier AF, Everington D, Baird DT. Potential impact of hormonal male contraception: cross-cultural implications for development of novel preparations. Hum Reprod. 2000 Mar;15(3):637-45. doi: 10.1093/humrep/15.3.637.
PMID: 10686211
citation: Merhi ZO, Santoro N. Postmenopausal virilization after spousal use of topical androgens. Fertil Steril. 2007 Apr;87(4):976.e13-5. doi: 10.1016/j.fertnstert.2006.07.1547. Epub 2007 Jan 24.
PMID: 17254577
citation: Miller MG, Rogol AD, Zumbrunnen TL. Secondary exposure to testosterone from patients receiving replacement therapy with transdermal testosterone gels. Curr Med Res Opin. 2012 Feb;28(2):267-9. doi: 10.1185/03007995.2011.652255. Epub 2012 Jan 20. No abstract available.
PMID: 22185432
citation: Nieschlag E, Zitzmann M, Kamischke A. Use of progestins in male contraception. Steroids. 2003 Nov;68(10-13):965-72. doi: 10.1016/s0039-128x(03)00135-1.
PMID: 14667989
citation: Rolf C, Knie U, Lemmnitz G, Nieschlag E. Interpersonal testosterone transfer after topical application of a newly developed testosterone gel preparation. Clin Endocrinol (Oxf). 2002 May;56(5):637-41. doi: 10.1046/j.1365-2265.2002.01529.x.
PMID: 12030915
citation: Shiraishi S, Lee PW, Leung A, Goh VH, Swerdloff RS, Wang C. Simultaneous measurement of serum testosterone and dihydrotestosterone by liquid chromatography-tandem mass spectrometry. Clin Chem. 2008 Nov;54(11):1855-63. doi: 10.1373/clinchem.2008.103846. Epub 2008 Sep 18.
PMID: 18801940
citation: Sitruk-Ware R. Transdermal delivery of steroids. Contraception. 1989 Jan;39(1):1-20. doi: 10.1016/0010-7824(89)90012-7.
PMID: 2642780
citation: Sitruk-Ware R. Transdermal application of steroid hormones for contraception. J Steroid Biochem Mol Biol. 1995 Jun;53(1-6):247-51. doi: 10.1016/0960-0760(95)00055-5.
PMID: 7626463
citation: Sitruk-Ware R, Small M, Kumar N, Tsong YY, Sundaram K, Jackanicz T. Nestorone: clinical applications for contraception and HRT. Steroids. 2003 Nov;68(10-13):907-13. doi: 10.1016/s0039-128x(03)00140-5.
PMID: 14667982
citation: Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Effect of application site, clothing barrier, and application site washing on testosterone transfer with a 1.62% testosterone gel. Curr Med Res Opin. 2012 Feb;28(2):281-90. doi: 10.1185/03007995.2011.652731. Epub 2012 Jan 25.
PMID: 22188557
citation: Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Effects of skin washing on systemic absorption of testosterone in hypogonadal males after administration of 1.62% testosterone gel. Curr Med Res Opin. 2012 Feb;28(2):271-9. doi: 10.1185/03007995.2011.652256. Epub 2012 Jan 17.
PMID: 22185431
citation: Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.
PMID: 22188558
citation: Swerdloff RS, Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ, Weber T, Longstreth J, Berman N. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab. 2000 Dec;85(12):4500-10. doi: 10.1210/jcem.85.12.7045.
PMID: 11134099
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responsible party type: Sponsor
mesh term: ST 1435
mesh term: Testosterone