NCT01268332

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for phase_2 healthy

Timeline
Completed

Started May 2011

Typical duration for phase_2 healthy

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2013

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

December 28, 2010

Last Update Submit

August 11, 2017

Conditions

Healthy

Keywords

Placebo IVR as a delivery method

Outcome Measures

Primary Outcomes (2)

  • Adherence to intravaginal ring

    Throughout study

  • Grade 2 or higher adverse event

    Throughout study

Study Arms (2)

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.

Drug: Non-medicated Intravaginal Ring

No Intravaginal Ring

NO INTERVENTION

Intravaginal ring will not be inserted into participants.

Interventions

Non-medicated Intravaginal RingDRUG

Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.

Also known as: Placebo Intravaginal Ring
Intravaginal Ring

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

Bronx-Lebanon Hospital Center

The Bronx, New York, United States

Location

National AIDS Research Institute

Pune, India

Location

Study Officials

  • Craig Hoesley, MD

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2010

First Posted

December 30, 2010

Study Start

May 1, 2011

Primary Completion

September 1, 2012

Study Completion

March 7, 2013

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

US(2)IN(1)