Birth ControlCONRAD-108NCT01178840
Prostate Specific Antigen (PSA) and Acute Failure Modes Study of the PATH Woman's Condom and FC2 Female Condom
A study testing WC then FC2 and FC2 then WC in people with Birth Control, run by CONRAD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Birth Control
- What is being tested?
- WC then FC2 and FC2 then WC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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).
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Family Health Council
Los Angeles, California, 90010
About this study
Official title: A Randomized Cross-Over Study of Vaginal Semen Exposure and Clinical Failure Comparing the PATH Woman's Condom and the FC2 Female Condom
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.
Read the 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 comparative, open-label two-period crossover study of up to 505 couples comparing the PATH Woman's Condom to the FC2 female condom. We will enroll up to 505 couples at the California Family Health Council 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.
Primary objective: To compare the performance of the PATH Woman's Condom (WC) to the FC2, as assessed by self-reported total clinical failure and its components (clinical breakage, slippage, misdirection, and invagination).
Secondary objectives:
- To compare the ability of the WC and the FC2 to prevent vaginal exposure to semen, as indicated by detection of PSA within the vagina
- To calculate the sensitivity and specificity of reported failures using PSA as the gold standard for the presence of semen
- To compare acceptability of the WC and FC2
Study Population: Healthy heterosexual couples at least 18 years of age and at low risk for pregnancy or STIs.
Study Size: up to 505 couples divided between multiple recruitment locations under one center.
Study Duration: Accrual will require approximately 14 months. Each couple will be expected to complete the study in 2-3 months. Therefore, the clinical portion of the study should be completed within approximately 17 months. Data preparation, analysis, and report writing are expected to require up to 7 months after completion of the clinical portion.
Treatment Regimen: The couples will be randomized to one of two condom use sequences (WC then FC2 or FC2 then WC). Four condoms of each type will be used by couples over two 2-4 week periods. For first period, one set of pre- and post-coital vaginal swabs will be collected around unprotected intercourse. For each coital act where a condom is used in the period, pre and post-coital vaginal swabs and a post-coital condom swab will be collected. A Condom Use Questionnaire will be completed after each condom use. An Acceptability Questionnaire will be completed at the end of each period. After a follow-up visit, these procedures will be repeated with the second 4 condoms, without collection of vaginal swabs at unprotected intercourse.
Study Center: California Family Health Council
Funding Source: United States Agency for International Development (USAID) \& National Institute for Child Health and Development (NICHD)
- Conditions
- Birth Control
- Being tested
- WC then FC2, FC2 then WC
- Keywords
- female condom, condom, clinical failure, prostate-specific antigen, semen exposure, acceptability, Prevention of semen exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WC then FC2Device
Also called WC = Woman's Condom, FC2 = Female Condom 2
4 uses of WC followed by 4 uses of FC2
FC2 then WCDevice
Also called WC = Woman's Condom, FC2 = Female Condom 2
4 uses of WC followed by 4 uses of FC2
| Study group | Role | What they receive |
|---|---|---|
| WC then FC2 | Other | The couples will use 4 PATH Woman's Condom then 4 FC2 female condom. Receives: Device: WC then FC2 |
| FC2 then WC | Other | The couples will use 4 FC2 female condom then 4 PATH Woman's Condom. Receives: Device: FC2 then WC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported clinical failure including clinical breakage, misdirection, slippage, and invagination
Measured: 8 condom uses over up to 3 months
Secondary outcomes (2)
Vaginal PSA levels
For each sex act, the change in vaginal PSA will be examine. The change in PSA will be equal to the PSA value from the POST-coital swab minus the PSA value from the PRE-coital swab. We will also collect swabs from one sex act without a condom as a positive control.
Measured: 8 condom uses over up to 3 months
Female condom acceptability
Measured: 8 condom uses over up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), PATH
- Responsible party
- Sponsor
- Investigators
- Jill L Schwartz, MD, Study director, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178840
- Sponsor's protocol ID
- CONRAD-108
- Acronym
- CONRAD-108
- Status last verified
- Mar 2012
- First submitted
- 4 Aug 2010
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31381878
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-Over Study of Vaginal Semen Exposure and Clinical Failure Comparing the PATH Woman's Condom and the FC2 Female Condom
- ClinicalTrials.gov ID
- NCT01178840
- Acronym / sponsor ID
- CONRAD-108 / CONRAD-108
- Conditions
- Birth Control
- Keywords
- female condom, condom, clinical failure, prostate-specific antigen, semen exposure, acceptability, Prevention of semen exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- CONRADUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), PATH
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 comparative, open-label two-period crossover study of up to 505 couples comparing the PATH Woman's Condom to the FC2 female condom. We will enroll up to 505 couples at the California Family Health Council 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.
Primary objective: To compare the performance of the PATH Woman's Condom (WC) to the FC2, as assessed by self-reported total clinical failure and its components (clinical breakage, slippage, misdirection, and invagination).
Secondary objectives:
- To compare the ability of the WC and the FC2 to prevent vaginal exposure to semen, as indicated by detection of PSA within the vagina
- To calculate the sensitivity and specificity of reported failures using PSA as the gold standard for the presence of semen
- To compare acceptability of the WC and FC2
Study Population: Healthy heterosexual couples at least 18 years of age and at low risk for pregnancy or STIs.
Study Size: up to 505 couples divided between multiple recruitment locations under one center.
Study Duration: Accrual will require approximately 14 months. Each couple will be expected to complete the study in 2-3 months. Therefore, the clinical portion of the study should be completed within approximately 17 months. Data preparation, analysis, and report writing are expected to require up to 7 months after completion of the clinical portion.
Treatment Regimen: The couples will be randomized to one of two condom use sequences (WC then FC2 or FC2 then WC). Four condoms of each type will be used by couples over two 2-4 week periods. For first period, one set of pre- and post-coital vaginal swabs will be collected around unprotected intercourse. For each coital act where a condom is used in the period, pre and post-coital vaginal swabs and a post-coital condom swab will be collected. A Condom Use Questionnaire will be completed after each condom use. An Acceptability Questionnaire will be completed at the end of each period. After a follow-up visit, these procedures will be repeated with the second 4 condoms, without collection of vaginal swabs at unprotected intercourse.
Study Center: California Family Health Council
Funding Source: United States Agency for International Development (USAID) \& National Institute for Child Health and Development (NICHD)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WC then FC2 | Other | Device: WC then FC2The couples will use 4 PATH Woman's Condom then 4 FC2 female condom. |
| FC2 then WC | Other | Device: FC2 then WCThe couples will use 4 FC2 female condom then 4 PATH Woman's Condom. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WC then FC2Also: WC = Woman's Condom, FC2 = Female Condom 24 uses of WC followed by 4 uses of FC2 | Device | WC then FC2 |
| FC2 then WCAlso: WC = Woman's Condom, FC2 = Female Condom 24 uses of WC followed by 4 uses of FC2 | Device | FC2 then WC |
Primary outcome
Self-reported clinical failure including clinical breakage, misdirection, slippage, and invagination
Time frame: 8 condom uses over up to 3 months
2 secondary outcomes
Vaginal PSA levels
Time frame: 8 condom uses over up to 3 months
Female condom acceptability
Time frame: 8 condom uses over up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
- Derived from this study: PubMed 31381878Walsh 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.
Related trials for Birth Control
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
Keloids
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill L Schwartz, MD study director
CONRAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WC then FC2 and FC2 then WC in people with Birth Control, run by CONRAD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported clinical failure including clinical breakage, misdirection, slippage, and invagination (time frame: 8 condom uses over up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.