Functionality of Male Condomes With a Silicone Elastomer Vaginal RIng

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01755741
First received: November 27, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

This trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing 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 Functionality of Male 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 (N slipped or broken/N total) off the penis or broke during intercourse or withdrawal, divided by the number of condoms used during intercourse. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: February 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal Ring
Placebo vaginal ring with condom use
Drug: vaginal ring
No Intervention: No vaginal ring

  Eligibility

Ages Eligible for Study:   18 Years to 55 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 condoms provided by trial personnel during the time of participation. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
  7. Agree to not use 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 to natural latex or vaginal lubricants such as Astroglide ®;
  4. History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
  5. Currently using condoms for protection against sexually transmitted infection;
  6. 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);
  7. 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;
  8. Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.);
  9. Current participation in a study or other research involving a drug, device or other product;
  10. 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: NCT01755741

Locations
United States, California
California Family Health Council
Berkley, California, United States, 94710
California Family Health Council
Los Angeles, California, United States, 90010
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Principal Investigator: Ron Frezieres California Family Health Council
  More Information

No publications provided

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01755741     History of Changes
Other Study ID Numbers: IPM 029
Study First Received: November 27, 2012
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014