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A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring

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ClinicalTrials.gov Identifier: NCT01755754
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Tracking Information
First Submitted Date  ICMJE December 14, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date September 28, 2017
Study Start Date  ICMJE August 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
Total clinical failure rate [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring
Official Title  ICMJE A Multicenter, Open-label, Randomized, Two-period, Crossover Non-inferiority Trial to Assess the Functionality of Female Condoms With a Silicone Elastomer Vaginal Ring
Brief Summary A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to assess the functionality of female condoms with a silicone elastomer vaginal ring.
Detailed Description This was an open-label, randomized, 2-period, crossover non-inferiority trial, conducted over 4.5 months at two research centers in the USA among 81 healthy, monogamous, heterosexual, sexually active couples to assess the functionality of female lubricated, nitrile condoms during vaginal intercourse in the presence and absence of a silicone elastomer placebo vaginal ring.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Human Immunodeficiency Virus
Intervention  ICMJE
  • Combination Product: Silicone Elastomer Vaginal Ring
    Silicone Elastomer Vaginal Ring
  • Device: Female Condom
    Female condom
Study Arms  ICMJE
  • Experimental: Silicone Elastomer Vaginal Ring
    Silicone Elastomer Vaginal Ring
    Intervention: Combination Product: Silicone Elastomer Vaginal Ring
  • Experimental: Female Condom
    This trial will test the performance of female condoms when used concurrently with a placebo vaginal ring
    Interventions:
    • Combination Product: Silicone Elastomer Vaginal Ring
    • Device: Female Condom
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2012)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Mutually monogamous heterosexual couples; current relationship ≥3 months; and who can give written informed consent;
  2. Age ≥18 to ≤45 years (females) or ≥18 to ≤55 years (males) at time of the screening visit;
  3. Healthy on the basis of medical history;
  4. Not at risk of pregnancy, i.e., female is surgically sterile, using an IUD, or using effective hormonal contraception, or has a vasectomized partner. The use of vaginal contraceptive rings will not be allowed;
  5. Sexually active and agree to have at least 8 acts of penile-vaginal intercourse using a study condom over 2 periods of up to 4 weeks each;
  6. Agree to use only the female condoms provided by trial personnel during the time of participation and not to use male condoms during the trial. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
  7. Agree to not use genital jewelry or other vaginal products, except menstrual absorption products (e.g., tampons) and study lubricant during the trial;
  8. Available for all visits and consent to follow all procedures scheduled for the trial;
  9. At low risk for HIV infection.

Exclusion Criteria:

  1. Males with untreated erectile dysfunction;
  2. Female with positive pregnancy test;
  3. Either partner allergic or hypersensitive to vaginal lubricants such as Astorlige ®
  4. Either partner not willing to refrain from wearing genital piercing jewelry for the duration of the study
  5. History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
  6. Consistently using male or female condoms for protection against sexually transmitted infection;
  7. Either partner taking any topical or oral medication to treat a urogenital condition at enrollment, except medication for the male partner to treat erectile dysfunction (e.g., tadalafil, sildenafil);
  8. Either partner with a self-reported or clinically diagnosed urogenital condition (e.g. itching, burning, irritation, etc.) that, in the opinion of the Investigator, could affect use of the study condoms or ability to interpret trial data;
  9. Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.)
  10. Current participation in a study or other research involving a drug, device or other product;
  11. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755754
Other Study ID Numbers  ICMJE IPM 033
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party International Partnership for Microbicides, Inc.
Study Sponsor  ICMJE International Partnership for Microbicides, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account International Partnership for Microbicides, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP