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: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Vaginal Inflammation
Vaginal Infections
Drug: Imiquimod
Drug: HEC Placebo
Drug: Nonoxynol-9
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

Resource links provided by NLM:


Further study details as provided by CONRAD:

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 [ Time Frame: Biopsies are performed 8 - 18 hours after exposure to each product ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: May 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IMQ product, 2 doses, vaginally
Imiquimod
Drug: Imiquimod
2 doses vaginally
Other Name: Aldara
Placebo Comparator: HEC placebo Drug: HEC Placebo
4 doses vaginally
Other Name: Hydroxyethylcellulose
Active Comparator: Nonoxynol-9 Drug: Nonoxynol-9
4 doses vaginally
Other Name: Conceptrol

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593124

Locations
United States, Virginia
Eastern Virginia Medical School CONRAD Clinical Research Center
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
CONRAD
Investigators
Principal Investigator: Andrea R Thurman, MD CONRAD Clinical Research Center, Eastern VA Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: CONRAD
ClinicalTrials.gov Identifier: NCT01593124     History of Changes
Other Study ID Numbers: D11-119
Study First Received: March 9, 2012
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by CONRAD:
Vaginal innate immune and inflammatory responses

Additional relevant MeSH terms:
Inflammation
Vaginitis
Mucositis
Pathologic Processes
Vaginal Diseases
Genital Diseases, Female
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Nonoxynol
Imiquimod
Spermatocidal Agents
Antispermatogenic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Male
Adjuvants, Immunologic
Immunologic Factors
Antineoplastic Agents
Interferon Inducers

ClinicalTrials.gov processed this record on July 28, 2014