HealthyPhase 2MTN-005NCT01268332
Safety and Adherence of a Non-medicated Intravaginal Ring (IVR)
A Phase 2 study testing Non-medicated Intravaginal Ring in people with Healthy, run by Population Council at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR in HIV uninfected women over 12 weeks of use. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Non-medicated Intravaginal Ring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2011to 7 Mar 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV uninfected
- General good health
- Sexually active
- Agree to use an effective method of contraception
- Normal Pap smear result within 12 months prior to study entry
- Agree to not participate in other drug or device research studies for the duration of study participation
- Agree to not use any intravaginal product for the duration of study participation
Who cannot join
- History of adverse reaction to silicone, latex, or titanium dioxide
- Current male sex partner with known history of adverse reaction to silicone, latex, or titanium dioxide
- Last pregnancy outcome within 30 days or less prior to enrollment
- History of hysterectomy
- Any abnormal pelvic exam finding
- Pregnant
- Condition that, in the opinion of the investigator, would interfere with the study
- Severe pelvic relaxation
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama
Bronx-Lebanon Hospital Center
The Bronx, New York
About this study
Official title: Expanded Safety and Adherence Study of a Non-medicated Intravaginal Ring
The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR in HIV uninfected women over 12 weeks of use.
Read the detailed description
Women comprise a growing proportion of new HIV infections worldwide. Intravaginal rings (IVRs) used to deliver microbicides have the potential to significantly reduce the heterosexual transmission of HIV if found to be safe, acceptable, and effective against HIV infection. This study will investigate the safety and acceptability of a non-medicated silicone elastomer IVR in sexually active HIV uninfected women.
The expected duration of this study for each participant is 16 weeks. Study participants will be randomly assigned to one of two arms. Participants in Group A will insert an IVR into their vagina at study entry. The IVR will remain in place for 12 weeks until removed by a physician. Follow up will continue for an additional 4 weeks after IVR removal. Participants in Group B will not receive an IVR, but will follow the same study schedule as those in Group A.
- Conditions
- Healthy
- Being tested
- Non-medicated Intravaginal Ring
- Keywords
- Placebo IVR as a delivery method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-medicated Intravaginal RingDrug
Also called Placebo Intravaginal Ring
Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Intravaginal Ring | Experimental | Insertion of intravaginal ring at enrollment. The intravaginal ring should stay in place for 12 consecutive weeks and will be removed by a physician at the Week 12 study visit. Receives: Drug: Non-medicated Intravaginal Ring |
| No Intravaginal Ring | No intervention | Intravaginal ring will not be inserted into participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to intravaginal ring
Measured: Throughout study
Grade 2 or higher adverse event
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completion7 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), Microbicide Trials Network
- Responsible party
- Sponsor
- Investigators
- Craig Hoesley, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268332
- Sponsor's protocol ID
- Population Council #508
- Acronym
- MTN-005
- Status last verified
- Aug 2017
- First submitted
- 28 Dec 2010
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Safety and Adherence Study of a Non-medicated Intravaginal Ring
- ClinicalTrials.gov ID
- NCT01268332
- Acronym / sponsor ID
- MTN-005 / Population Council #508
- Conditions
- Healthy
- Keywords
- Placebo IVR as a delivery method
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), Microbicide Trials Network
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- 7 Mar 2013 (actual)
- First posted
- 30 Dec 2010 (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.
The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR in HIV uninfected women over 12 weeks of use.
Detailed description
Women comprise a growing proportion of new HIV infections worldwide. Intravaginal rings (IVRs) used to deliver microbicides have the potential to significantly reduce the heterosexual transmission of HIV if found to be safe, acceptable, and effective against HIV infection. This study will investigate the safety and acceptability of a non-medicated silicone elastomer IVR in sexually active HIV uninfected women.
The expected duration of this study for each participant is 16 weeks. Study participants will be randomly assigned to one of two arms. Participants in Group A will insert an IVR into their vagina at study entry. The IVR will remain in place for 12 weeks until removed by a physician. Follow up will continue for an additional 4 weeks after IVR removal. Participants in Group B will not receive an IVR, but will follow the same study schedule as those in Group A.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravaginal Ring | Experimental | Drug: Non-medicated Intravaginal RingInsertion of intravaginal ring at enrollment. The intravaginal ring should stay in place for 12 consecutive weeks and will be removed by a physician at the Week 12 study visit. |
| No Intravaginal Ring | No intervention | –Intravaginal ring will not be inserted into participants. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- HIV uninfected
- General good health
- Sexually active
- Agree to use an effective method of contraception
- Normal Pap smear result within 12 months prior to study entry
Key exclusion criteria (8 listed)
- History of adverse reaction to silicone, latex, or titanium dioxide
- Current male sex partner with known history of adverse reaction to silicone, latex, or titanium dioxide
- Last pregnancy outcome within 30 days or less prior to enrollment
- History of hysterectomy
- Any abnormal pelvic exam finding
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 |
|---|---|---|
| Non-medicated Intravaginal RingAlso: Placebo Intravaginal RingCured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient. | Drug | Intravaginal Ring |
Primary outcome
Adherence to intravaginal ring
Time frame: Throughout study
Grade 2 or higher adverse event
Time frame: Throughout study
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 15 Aug 2017.
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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.
Craig Hoesley, MD study chair
University of Alabama at Birmingham
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Non-medicated Intravaginal Ring in people with Healthy, run by Population Council at 3 sites in 2 countries.
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 7 inclusion and 8 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, India. 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. 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?
Adherence to intravaginal ring (time frame: Throughout study). The study lists 2 primary outcomes in all. 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 15 Aug 2017.