Status:
COMPLETED
Prostate Specific Antigen (PSA) and Acute Failure Modes Study of the PATH Woman's Condom and FC2 Female Condom
Lead Sponsor:
CONRAD
Collaborating Sponsors:
United States Agency for International Development (USAID)
PATH
Conditions:
Birth Control
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a comparative, open-label two-period crossover study of up to 505 couples comparing the PATH Woman's Condom to the FC2 female condom. California Family Health Council will enroll up to 505 cou...
Detailed Description
Purpose: To compare the performance of a new female condom (PATH Woman's Condom) with an FDA-approved female condom (FC2), as assessed by reported clinical failure and vaginal PSA Design: This is a c...
Eligibility Criteria
Inclusion
- Heterosexual couples
- Mutual monogamy for 3 or more months
- Both partners are 18 years of age or greater
- Using effective contraception for more than 3 months, including hormonal methods (oral, injectable, or transdermal), intrauterine device, contraceptive implant, male or female sterilization
- Agree to remain monogamous for the duration of the study
- Agree not to wear any genital piercing jewelry while using study condoms
- Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using a study condom
- Evidence of general good health without contraindication to sexual activity
- Couple has vaginal intercourse at least 4 times in a typical month
- Male partner agrees to ejaculate during intercourse using female condoms
- Willing and able to participate as required by protocol
Exclusion
- Exclusion criteria for couple (either partner)
- Intent or desire to become pregnant within 3 months
- STIs in the past 6 months, including chlamydia, gonorrhea, trichomoniasis, syphilis, or newly acquired HSV
- Couple routinely uses condoms due to concern for STIs (for more than 90% of sex acts)
- Known HIV infection
- At high risk for HIV infection, including having shared injection drug needles or having had sex with someone suspected to have HIV (without having had a negative HIV test since the possible exposure).
- Allergies to polyurethane or nitrile plastics, or vaginal lubricants (silicone or Astroglide)
- Recent surgery or biopsy of the male or female genitalia, within the past 60 days including the vulva, vagina, cervix, penis, prostate, vas deferens, or testes
- Current participation in a study or other research involving a drug, device, or other product. (Participation in an observational study is not exclusionary).
- Exclusion criteria for female partner
- Positive pregnancy test
- Within 2 months of the end of pregnancy
- Concern for current pregnancy: history of unprotected intercourse since last menses without consistent use of other contraception
- Use of a contraceptive vaginal ring (Nuvaring)
- Current use of vaginal products, for treatment of vaginal infection
- Routine use of diaphragm or vaginal pessary
- Polycystic ovarian syndrome (oligomenorrhea and hirsutism or prior diagnosis)
- Distorted vaginal anatomy (e.g. vaginal septum or pelvic prolapse)
- Exclusion criteria for male partner
- Difficulty maintaining an erection or achieving ejaculation in the last two months
- At high risk for HIV infection, including having had anal sex with a man in the last year
- Prior prostate surgery
- History of or current prostate cancer
- Use of medication for a prostate condition
- Hypospadias or other abnormal penile or male urethral anatomy
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT01178840
Start Date
July 1 2010
End Date
June 1 2011
Last Update
December 12 2013
Active Locations (1)
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1
California Family Health Council
Los Angeles, California, United States, 90010