Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

Vaginal Infections Clinical Trial

— Biomarkers  

Official title:

Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593124
• Other study ID #: D11-119
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2012
• Last updated: March 30, 2015
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2015
• Source: CONRAD
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation
• Mucositis
• Vaginal Infections
• Vaginal Inflammation
• Vaginitis

Intervention

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:
• 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.

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.

Locations

Country	Name	City	State
United States	Eastern Virginia Medical School CONRAD Clinical Research Center	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CONRAD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Study Sponsor