Vaginal InflammationPhase 2BiomarkersNCT01593124
Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation
A Phase 2 study testing Imiquimod and Nonoxynol-9 in people with Vaginal Inflammation and Vaginal Infections, run by CONRAD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Inflammation, Vaginal Infections
- What is being tested?
- Imiquimod and Nonoxynol-9
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School CONRAD Clinical Research Center
Norfolk, Virginia, 23507
About this study
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.
Read the 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.
- Conditions
- Vaginal Inflammation, Vaginal Infections
- Being tested
- Imiquimod, Placebo, Nonoxynol-9
- Keywords
- Vaginal innate immune and inflammatory responses
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Also called Aldara
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.
PlaceboOther
Also called Hydroxyethylcellulose
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.
Nonoxynol-9Drug
Also called Conceptrol
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Nonoxynol-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Biopsies are performed 8 - 18 hours after exposure to each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea R Thurman, MD, Principal investigator, CONRAD Clinical Research Center, Eastern VA Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593124
- Sponsor's protocol ID
- D11-119
- Acronym
- Biomarkers
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2012
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation
- ClinicalTrials.gov ID
- NCT01593124
- Acronym / sponsor ID
- Biomarkers / D11-119
- Conditions
- Vaginal Inflammation, Vaginal Infections
- Keywords
- Vaginal innate immune and inflammatory responses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imiquimod, 2 doses, vaginally | Active comparator | Drug: ImiquimodParticipants 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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
| Nonoxynol-9 | Active comparator | Drug: Nonoxynol-9Participants 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImiquimodAlso: AldaraParticipants 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, 2 doses, vaginally |
| PlaceboAlso: HydroxyethylcelluloseParticipants 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-9Also: ConceptrolParticipants 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 |
Primary outcome
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
These data are still undergoing analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Study SponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea R Thurman, MD principal investigator
CONRAD Clinical Research Center, Eastern VA Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imiquimod and Nonoxynol-9 in people with Vaginal Inflammation and Vaginal Infections, run by CONRAD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.