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Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation (Biomarkers)

Primary Purpose

Vaginal Inflammation, Vaginal Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Imiquimod
Placebo
Nonoxynol-9
Sponsored by
CONRAD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vaginal Inflammation focused on measuring Vaginal innate immune and inflammatory responses

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 21 to 45 years of age, inclusive;
  2. In good health, as evidenced by history and procedures at screening and enrollment visits without any clinically significant systemic disease;
  3. Not be at risk for pregnancy, due to surgical sterilization of participant and or her sexual partner, abstinence for duration of study, consistent condom use, non-hormonal IUD or same sex relationship. Note: If consistent condom user, must agree to use condoms without spermicide for duration of study.;
  4. Have had regular menstrual cycles (every 24-35 days) for the past two cycles;
  5. Willing and able to comply with study procedures

Exclusion Criteria:

  1. A clinically significant history of an abnormal pap smear (by written report) that has not been evaluated and or treated, if indicated, according to standard guidelines;
  2. It has been less than 9 months since the participant's last depot medroxyprogesterone acetate (DMPA) injection and she has not had 2 normal, spontaneous menses (this can be shortened to 6 months if the participant has had at least 2 normal spontaneous menses);
  3. Use of any other hormonal contraceptive method within past 3 months (oral, transdermal, transvaginal, implant, or intrauterine device) without 2 subsequent, normal menses;
  4. Surgery or biopsy of the vulva, vagina, or cervix (including piercings) within 30 days;
  5. Pregnancy within the past 3 months;
  6. Currently breastfeeding;
  7. Current STI or lower genital tract infection (including, but not limited to HIV-1, HSV-2, Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Neisseria Protocol # D11-119 Version 2.0 April 13, 2012 10 gonorrhea (NG), Hepatitis B, high risk HPV sub types and or Syphilis), yeast vaginitis or bacterial vaginosis (BV);
  8. Current use of chronic immunosuppressants (for example daily steroids or daily non-steroidal anti-inflammatory drugs [NSAIDs]);
  9. Current presence of vulvar, anal and or vaginal genital warts;
  10. Current tobacco use of any amount;
  11. Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise the ability to comply with study protocols, such as any major chronic illness including but not limited to cancer, serious autoimmune disease, metabolic disorders or a major psychiatric disorder (e.g., schizophrenia); and
  12. Current participation in any other drug or device study, or any study which, in the

Sites / Locations

  • Eastern Virginia Medical School CONRAD Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Imiquimod, 2 doses, vaginally

Placebo

Nonoxynol-9

Arm Description

Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.

Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.

Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.

Outcomes

Primary Outcome Measures

Differential Microarray gene expression (particularly looking at pathways involved in inflammation and immune response) in vaginal tissues after exposure to N9, HEC or imiquimod
These data are still undergoing analysis

Secondary Outcome Measures

Full Information

First Posted
March 9, 2012
Last Updated
March 30, 2015
Sponsor
CONRAD
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1. Study Identification

Unique Protocol Identification Number
NCT01593124
Brief Title
Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation
Acronym
Biomarkers
Official Title
Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CONRAD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigates the response of vaginal and cervical tissue after exposure to three vaginal products: hydroxyethyl cellulose (HEC) placebo, nonoxynol-9 (N9) and imiquimod (IMQ) cream.
Detailed Description
Each woman in this study will be evaluated 5 separate times: Baseline in the follicular phase of the menstrual cycle; Baseline in the luteal phase of the menstrual cycle; After a 3 day (4 dose) treatment with HEC placebo; After a 3 day (4 dose) treatment of 4% N-9; After a 2 day (2 dose) treatment of IMQ. A subset of 5 women will have an additional baseline visit in the follicular phase. The order of the N-9 and IMQ treatments is randomized. The study is cross over in design. The per sequence of treatments is as follows: Baseline in the follicular phase of the menstrual cycle, next is baseline in the luteal phase of the menstrual cycle, next is after a 3 day (4 dose) treatment with HEC placebo. At this point in the study, half of the participants are randomized to do the N-9 treatment and then the IMQ treatment. The remaining half of the participants do the IMQ treatment and then the N-9 treatment. All participants are sampled at the 5 timepoints described above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Inflammation, Vaginal Infections
Keywords
Vaginal innate immune and inflammatory responses

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod, 2 doses, vaginally
Arm Type
Active Comparator
Arm Description
Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
Arm Title
Nonoxynol-9
Arm Type
Active Comparator
Arm Description
Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Other Intervention Name(s)
Aldara
Intervention Description
Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Hydroxyethylcellulose
Intervention Description
Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
Intervention Type
Drug
Intervention Name(s)
Nonoxynol-9
Other Intervention Name(s)
Conceptrol
Intervention Description
Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
Primary Outcome Measure Information:
Title
Differential Microarray gene expression (particularly looking at pathways involved in inflammation and immune response) in vaginal tissues after exposure to N9, HEC or imiquimod
Description
These data are still undergoing analysis
Time Frame
Biopsies are performed 8 - 18 hours after exposure to each product

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21 to 45 years of age, inclusive; In good health, as evidenced by history and procedures at screening and enrollment visits without any clinically significant systemic disease; Not be at risk for pregnancy, due to surgical sterilization of participant and or her sexual partner, abstinence for duration of study, consistent condom use, non-hormonal IUD or same sex relationship. Note: If consistent condom user, must agree to use condoms without spermicide for duration of study.; Have had regular menstrual cycles (every 24-35 days) for the past two cycles; Willing and able to comply with study procedures Exclusion Criteria: A clinically significant history of an abnormal pap smear (by written report) that has not been evaluated and or treated, if indicated, according to standard guidelines; It has been less than 9 months since the participant's last depot medroxyprogesterone acetate (DMPA) injection and she has not had 2 normal, spontaneous menses (this can be shortened to 6 months if the participant has had at least 2 normal spontaneous menses); Use of any other hormonal contraceptive method within past 3 months (oral, transdermal, transvaginal, implant, or intrauterine device) without 2 subsequent, normal menses; Surgery or biopsy of the vulva, vagina, or cervix (including piercings) within 30 days; Pregnancy within the past 3 months; Currently breastfeeding; Current STI or lower genital tract infection (including, but not limited to HIV-1, HSV-2, Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Neisseria Protocol # D11-119 Version 2.0 April 13, 2012 10 gonorrhea (NG), Hepatitis B, high risk HPV sub types and or Syphilis), yeast vaginitis or bacterial vaginosis (BV); Current use of chronic immunosuppressants (for example daily steroids or daily non-steroidal anti-inflammatory drugs [NSAIDs]); Current presence of vulvar, anal and or vaginal genital warts; Current tobacco use of any amount; Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise the ability to comply with study protocols, such as any major chronic illness including but not limited to cancer, serious autoimmune disease, metabolic disorders or a major psychiatric disorder (e.g., schizophrenia); and Current participation in any other drug or device study, or any study which, in the
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea R Thurman, MD
Organizational Affiliation
CONRAD Clinical Research Center, Eastern VA Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Virginia Medical School CONRAD Clinical Research Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Links:
URL
http://conrad.org
Description
Study Sponsor

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Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

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