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Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CONRAD
ClinicalTrials.gov Identifier:
NCT01593124
First received: March 9, 2012
Last updated: February 4, 2015
Last verified: February 2015

March 9, 2012
February 4, 2015
May 2012
April 2013   (final data collection date for primary outcome measure)
Differential Microarray gene expression (particularly looking at pathways involved in inflammation and immune response) in vaginal tissues after exposure to N9, HEC or imiquimod [ Time Frame: Biopsies are performed 8 - 18 hours after exposure to each product ] [ Designated as safety issue: No ]
These data are still undergoing analysis
Differential Microarray gene expression (particularly looking at pathways involved in inflammation and immune response) in vaginal tissues after exposure to N9, HEC or imiquimod [ Time Frame: Biopsies are performed 8 - 18 hours after exposure to each product ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01593124 on ClinicalTrials.gov Archive Site
Not Provided
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Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation
Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

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.

Each woman in this study will be evaluated 5 separate times:

  1. Baseline in the follicular phase of the menstrual cycle;
  2. Baseline in the luteal phase of the menstrual cycle;
  3. After a 3 day (4 dose) treatment with HEC placebo;
  4. After a 3 day (4 dose) treatment of 4% N-9;
  5. After a 2 day (2 dose) treatment of IMQ.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Vaginal Inflammation
  • Vaginal Infections
  • Drug: Imiquimod
    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.
    Other Name: Aldara
  • Other: Placebo
    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.
    Other Name: Hydroxyethylcellulose
  • Drug: Nonoxynol-9
    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.
    Other Name: Conceptrol
  • Active Comparator: Imiquimod, 2 doses, vaginally
    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: Drug: Imiquimod
  • Placebo Comparator: Placebo
    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: Other: Placebo
  • Active Comparator: Nonoxynol-9
    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: Drug: Nonoxynol-9
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2013
April 2013   (final data collection date for primary outcome measure)

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, consistent condom use, non-hormonal IUD or same sex relationship
  4. Have had regular menstrual cycles (every 21-35 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 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 opinion of the investigator, would jeopardize interpretation of results of this study.
Female
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01593124
D11-119
No
CONRAD
CONRAD
Not Provided
Principal Investigator: Andrea R Thurman, MD CONRAD Clinical Research Center, Eastern VA Medical School
CONRAD
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP