Prostate Specific Antigen (PSA) and Acute Failure Modes Study of the PATH Woman's Condom and FC2 Female Condom

NCT01178840 | Completed

• 1 other identifier: CONRAD-108
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

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 couples to have 375 complete both periods. The study will provide data on functional performance, vaginal semen exposure, safety, and acceptability of the two female condoms. Both partners will be required to come to the clinic to be consented for the study. If both members of the couple meet all eligibility requirements, they will each sign an informed consent form and will be enrolled as a couple. The couples will be randomized to one of two female condom use sequences for the two periods (WC then FC2 or FC2 then WC). For the first period of 2-4 weeks, the couple will be asked to have sex once without a condom and 4 times using the first assigned female condom. For the second period of 2-4 weeks, the couple will be asked to have sex 4 times using the second assigned female condom. In the first period, the couple will have one act of unprotected sex for which they will collect pre- and post-coital vaginal swabs. The couple will also use 4 female condoms of the assigned type. They will be asked to collect pre- and post-coital vaginal swabs and a post-coital swab from the condom interior. The couple will complete a detailed Condom Use Questionnaire together after each condom use. An Acceptability Questionnaire will be completed separately by males and females at the end of each study period. Couples may have additional acts of sex during each period as they desire but will not have sex at least 48 hours prior to each study sex act. After a follow-up visit, the procedures will be repeated with 4 of the second assigned condom type but without the collection of vaginal swabs at unprotected intercourse. Each couple will be enrolled for about 2-3 months, depending on the intervals between sex acts. Clinicians evaluating product-relatedness of AEs will be blinded to the condom type used. Male partners will be requested to attend the final visit, and, if they experience adverse events, the followup and/or unscheduled visits.

Conditions

Birth Control

Keywords

female condom; condom; clinical failure; prostate-specific antigen; semen exposure; acceptability; Prevention of semen exposure

Outcome Measures

Primary Outcomes (1)

• Self-reported clinical failure including clinical breakage, misdirection, slippage, and invagination

  8 condom uses over up to 3 months

Secondary Outcomes (2)

• Vaginal PSA levels

  8 condom uses over up to 3 months

• Female condom acceptability

  8 condom uses over up to 3 months

Study Arms (2)

WC then FC2

OTHER

The couples will use 4 PATH Woman's Condom then 4 FC2 female condom.

Device: WC then FC2

FC2 then WC

OTHER

The couples will use 4 FC2 female condom then 4 PATH Woman's Condom.

Device: FC2 then WC

Interventions

WC then FC2 DEVICE

4 uses of WC followed by 4 uses of FC2

Also known as: WC = Woman's Condom, FC2 = Female Condom 2

WC then FC2

FC2 then WC DEVICE

4 uses of WC followed by 4 uses of FC2

Also known as: WC = Woman's Condom, FC2 = Female Condom 2

FC2 then WC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• CONRAD: lead
• United States Agency for International Development (USAID): collaborator
• PATH: collaborator

Study Sites (1)

California Family Health Council

Los Angeles, California, 90010, United States

Location

Related Publications (1)

• Walsh TL, Snead MC, St Claire BJ, Schwartz JL, Mauck CK, Frezieres RG, Blithe DL, Archer DF, Barnhart KT, Jensen JT, Nelson AL, Thomas MA, Wan LS, Weaver MA. Comparison of self-reported female condom failure and biomarker-confirmed semen exposure. Contraception. 2019 Nov;100(5):406-412. doi: 10.1016/j.contraception.2019.07.143. Epub 2019 Aug 2.

  PMID: 31381878 DERIVED

Study Officials

• Jill L Schwartz, MD

  CONRAD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 10, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 12, 2013

Record last verified: 2012-03

Locations

US (1)