Female Condom Functionality

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by International Partnership for Microbicides, Inc.
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01755754
First received: December 14, 2012
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

Trial being conducted to assess the total clinical failure rate and its components of a female condom used during vaginal intercourse in the presence and absence of the vaginal ring.


Condition Intervention
Condom Functionality
Drug: vaginal ring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Multicenter, Open-label, Randomized, Two-period, Crossover Non-inferiority Trial to Assess the FunctionalityY of Female Condoms With a Silicone Elastomer Vaginal Ring

Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • Total clinical failure rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: August 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No ring - condom only
Placebo Comparator: placebo vaginal ring
Female condom used with vaginal ring
Drug: vaginal ring

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755754

Contacts
Contact: Ron Frezieres 213-386-5614 ext 4403 frezieres@cfhc.org

Locations
United States, California
California Family Health Council Recruiting
Los Angeles, California, United States, 90010
Contact: Seline Guidotti    877-437-2007      
Contact: Kate Hodges    800-300-5767      
Principal Investigator: Ron Frezieres         
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
  More Information

No publications provided

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01755754     History of Changes
Other Study ID Numbers: IPM 033
Study First Received: December 14, 2012
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014