A trial to study how safe and whether women can use as instructed an intravginal ring that contains no medication.

Phase 2

Completed

• Registration Number: CTRI/2012/02/002422
• Lead Sponsor: Division of AIDS NIH US

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 252

Inclusion Criteria

Women must meet all of the following criteria to be eligible for inclusion in the study:

1.Age 18-45 years (inclusive) at Enrollment, verified per site standard operating procedures (SOP)

2.Willing and able to provide written informed consent to be screened for and to take part in the study

3.Willing and able to provide adequate locator information, as defined in site SOPs

4.HIV-uninfected at Screening based on testing performed by study staff at Screening (per algorithm in Appendix II) and willing to receive HIV counseling and test results

5.In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee

6.Per participant report at Screening and Enrollment, sexually active, defined as having had penile-vaginal intercourse at least once in the past 30 days prior to Screening and Enrollment

7.Per participant report at Screening and Enrollment, expecting to continue penile-vaginal intercourse at least monthly for the duration of study participation

8.Per participant report, using an effective method of contraception at Enrollment, and intending to use an effective method for the duration of study participation. Effective methods include hormonal methods (except contraceptive vaginal rings), IUD inserted at least 7 days prior to enrollment, study provided male condoms, and/or sterilization (of participant or her sexual partner(s) as specified in site SOPs)

9.Pap result in the 12 calendar months prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009) or satisfactory evaluation with no treatment required of non-Grade 0 Pap result per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines or per local standard of care, in the 12 calendar months prior to the Enrollment Visit

10. At Screening and Enrollment, agrees not to participate in other drug or device research study for the duration of study participation

11.Able and willing to abstain from the use of non-study vaginal products and/or practices (other than tampons) including but not limited to spermicides, diaphragms, contraceptive vaginal rings, vaginal antibiotic or antifungal medication, sex toys, lubricants or condoms that contain silicone, menstrual cup and douching, within the 14 days prior to Enrollment through study termination

Exclusion Criteria

Women who meet any of the following criteria will be excluded from the study:

1.Participant reported history of:

a.Adverse reaction to silicone (ever)

b.Adverse reaction to latex (as defined per SSP)

c.Adverse reaction to titanium dioxide

d.Any current male sex partner with known history of adverse reaction to latex, silicone, titanium dioxide or any components of the study product (as defined per SSP)

e.Last pregnancy outcome within 30 days or less prior to enrollment

f.Hysterectomy

2.At Screening or Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009), Addendum 1, Female Genital Grading Table for Use in Microbicide Studies

Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary.

Note: Otherwise eligible participants with exclusionary pelvic examination findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved. If improvement to a non-exclusionary grade or resolution is documented within 45 days of providing informed consent for Screening, the participant may be enrolled.

3.Pregnant at Screening or Enrollment, or per participant report intending to become pregnant during the period of study participation

4.At Screening or Enrollment:

a.Unwilling to comply with study participation requirements

b.Has a clinically apparent deep disruption of vulvar, vaginal, or cervical epithelium (colposcopic findings not visible by naked eye are not exclusionary)

c.Is diagnosed with a symptomatic urinary tract infection (see additional information below)

d.Is diagnosed with a reproductive tract infection (RTI) or syndrome requiring treatment per current US Centers for Disease Control (CDC) guidelines (see additional information below)

e.Has any other abnormal physical or pelvic exam finding that, in the opinion of the investigator or designee, would contraindicate study participation

Note: RTIs requiring treatment, per site specific treatment guidelines, include BV, vaginal candidiasis, other vaginitis, trichomoniasis, chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions (HSV-2 seropositive women not excluded except with active lesions), chancroid, pelvic inflammatory disease, genital sores or ulcers, or cervicitis. Otherwise eligible participants diagnosed with RTI and/or UTI during Screening will be offered treatment or a prescription for treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for Screening, the participant may be enrolled.

5.At Screening or Enrollment, has condition that, in the investigatorâ??s opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

6.Severe pelvic relaxation such that eith

Study & Design

• Study Type: Interventional
• Study Design: Not specified