- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01593124
Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation (Biomarkers)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School CONRAD Clinical Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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.
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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These data are still undergoing analysis
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Biopsies are performed 8 - 18 hours after exposure to each product
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea R Thurman, MD, CONRAD Clinical Research Center, Eastern VA Medical School
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Vaginal Diseases
- Inflammation
- Vaginitis
- Mucositis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Interferon Inducers
- Contraceptive Agents, Male
- Spermatocidal Agents
- Antispermatogenic Agents
- Imiquimod
- Nonoxynol
Other Study ID Numbers
- D11-119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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