Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

NCT01593124 | Completed Phase 2

• 1 other identifier: D11-119
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Inflammation; Vaginal Infections

Keywords

Vaginal innate immune and inflammatory responses

Outcome Measures

Primary Outcomes (1)

• 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

  Biopsies are performed 8 - 18 hours after exposure to each product

Study Arms (3)

Imiquimod, 2 doses, vaginally

ACTIVE COMPARATOR

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.

Drug: Imiquimod

Placebo

PLACEBO COMPARATOR

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: Placebo

Nonoxynol-9

ACTIVE COMPARATOR

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.

Drug: Nonoxynol-9

Interventions

Imiquimod DRUG

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.

Also known as: Aldara

Imiquimod, 2 doses, vaginally

Placebo OTHER

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.

Also known as: Hydroxyethylcellulose

Placebo

Nonoxynol-9 DRUG

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.

Also known as: Conceptrol

Nonoxynol-9

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CONRAD: lead

Study Sites (1)

Eastern Virginia Medical School CONRAD Clinical Research Center

Norfolk, Virginia, 23507, United States

Location

Related Links

• Study Sponsor

MeSH Terms

Conditions

Vaginitis

Interventions

Imiquimod; hydroxyethylcellulose; Nonoxynol

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Andrea R Thurman, MD

  CONRAD Clinical Research Center, Eastern VA Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: May 7, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (1)