PSANCT02934620
Promoting CSD500 Use Among Women in Established Relationships
A study testing CSD500 Condom, Standard Condom and Condom Counseling in people with PSA and Unprotected Sex, run by Ohio State University at 1 site in Vietnam.
Trial summary
Globally, women in established relationships remain at risk for unintended pregnancy and sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the proposed research, unmet need for contraception is substantial as reflected in the nation's high abortion ratio. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- PSA, Unprotected Sex
- What is being tested?
- CSD500 Condom, Standard Condom and Condom Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteVietnam
- Study dates
- 9 Jun 2017to 19 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not currently using a modern contraceptive method other than condoms or intending to start using a modern contraceptive method other than condoms in the next 6 months;
- Willing to use assigned study condoms as the sole method of contraception for the next six months;
- Not breastfeeding;
- Not known to be pregnant;
- Want to avoid pregnancy for at least the next six months; and
- Be in a monogamous relationship for at least the past six months with her current male partner.
Who cannot join
- Couples are ineligible for study participation if either person in the couple is known to be HIV-positive or has any of the following contraindications to CSD500 use:
- History of low blood pressure or heart condition;
- Current use of medication for anemia, blood pressure, erectile dysfunction, migraines, headaches or glaucoma;
- Inflamed or broken skin that the condom could come into contact with; or
- Latex allergy or sensitivity.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Thanh Hoa Provincial Centre of Reproductive Health
Thanh Hóa, Thanh Hóa Province
About this study
Globally, women in established relationships remain at risk for unintended pregnancy and sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the proposed research, unmet need for contraception is substantial as reflected in the nation's high abortion ratio. Married women account for about one-third of HIV cases in Vietnam, and among this group, most were exposed to the virus through sexual activity with their husband. Condoms will remain crucial for prevention for some time to come. Sustained condom use, however, is notoriously difficult to achieve. A key barrier to the consistent use of condoms is their effect on sexual pleasure. Although sexual pleasure is a primary motivation for engaging in sex and is an integral part of overall sexual health, most programs to improve sexual health operate within a pregnancy and disease-prevention paradigm. A new condom, CSD500, containing an erectogenic drug was developed for use among healthy couples to improve sexual pleasure by increasing penile firmness, size and erection duration. The overall objective of the proposed two-arm randomized trial is to test whether promoting the novel condom CSD500 for improved sexual pleasure results in couples having less unprotected vaginal sex. Investigators will measure the occurrence of unprotected vaginal sex by testing women's vaginal fluid for the presence of prostate-specific antigen (PSA), an objective, biological marker of recent semen exposure. Investigators will randomize 500 adult, heterosexual, monogamous couples, comprised of a total of 1000 individuals, in Thanh Hoa province, Vietnam to receive either CSD500 for sexual pleasure or the standard condom currently provided only for pregnancy and disease prevention to patients during routine care. Study staff will interview female participants at enrollment and after 2, 4, and 6 months and their male partners at the 6-month visit. Study clinicians will sample vaginal fluid from female participants at all visits to test for the presence of PSA.
Read the detailed description
This randomized controlled trial will test whether promoting the novel condom CSD500 (Futura Medical Developments; Surrey, UK) for improved sexual pleasure results in couples having less unprotected vaginal sex - measured with a biological marker of recent semen exposure - compared to the promotion of a standard condom for disease and pregnancy prevention. CSD500 contains an erectogenic drug and was developed to improve sexual pleasure by increasing penile firmness, size, and erection duration.
Investigators will recruit eligible, monogamous, heterosexual couples at Thanh Hoa Provincial Centre of Reproductive Health in Vietnam to participate in a randomized controlled trial (RCT) of two balanced arms of approximately 250 heterosexual couples each, for a total of 500 couples, comprised of 1000 individuals. At enrollment and at three follow-up visits scheduled at 2, 4 and 6 months after enrollment, study staff will provide condom counseling, will collect vaginal swabs to test for the semen biomarker, prostate-specific antigen (PSA), and will administer a questionnaire to the female participants on their demographics, sexual and condom-related attitudes and practices, including sexual pleasure and perceptions of partner's sexual pleasure. Although the intervention is directed to the women, couples will be enrolled to ensure that the male partners consent to CSD500 use. After enrollment, male participants will not participate in study visit activities, including data collection, until the time of their female partner's final 6-month visit. Because of the differences in counseling messages, participants and study staff at the site cannot be blinded to arm assignment.
- Conditions
- PSA, Unprotected Sex
- Being tested
- CSD500 Condom, Standard Condom, Condom Counseling
- Keywords
- pregnancy, condom, HIV, sexually transmitted infections
- Medical subject headings
- Unsafe Sex, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSD500 CondomDevice
Also called Blue Diamond
CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.
Standard CondomDevice
The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.
Condom CounselingBehavioural
The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
| Study group | Role | What they receive |
|---|---|---|
| CSD500 Condom | Experimental | Receive CSD500 condoms with condom counseling to use them for sexual pleasure. Receives: Device: CSD500 Condom; Behavioral: Condom Counseling |
| Standard Condom | Active comparator | Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Receives: Device: Standard Condom; Behavioral: Condom Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Female Participants With Positive PSA at 2-Month Visit
A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.
Measured: Vaginal swab collected at 2-month follow-up visit
Number of Female Participants With Positive PSA at 4-Month Visit
A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.
Measured: Vaginal swab collected at 4-month follow-up visit
Number of Female Participants With Positive PSA at 6-Month Visit
A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.
Measured: Vaginal swab collected at 6-month follow-up visit
Secondary outcomes (6)
Number of Female Participants With Self-reported Condomless Sex at 2-month Follow-up Visit
Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.
Measured: Measured at 2-month follow-up visit
Quality of Sexual Experience (QSE) Scale Scores Among Participants at 6-month Visit
The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women and men's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.
Measured: Measured among participants at at 6-month follow-up visit
Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 2-month Visit
The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.
Measured: Measured among female participants at at 2-month follow-up visit
Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 4-month Visit
The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.
Measured: Measured among female participants at at 4-month follow-up visit
Number of Female Participants With Self-reported Condomless Sex at 4-month Follow-up Visit
Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.
Measured: Measured at 4-month follow-up visit
Number of Female Participants With Self-reported Condomless Sex at 6-month Follow-up Visit
Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.
Measured: Measured at 6-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start9 Jun 2017
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PSAStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Vietnam, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Maria F. Gallo, PhD, Ohio State University
- Investigators
- Maria Gallo, PhD, Principal investigator, Ohio State UniversityJohn Casterline, PhD, Principal investigator, Ohio State UniversityRebecca Andridge, PhD, Principal investigator, Ohio State UniversityMarcia Hobbs, PhD, Principal investigator, University of North CarolinaNghia Nguyen, MD, PhD, Principal investigator, Ministry of Health, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934620
- Sponsor's protocol ID
- 2015H0242
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2016
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen NC, Luong TN, Le VT, Hobbs M, Andridge R, Casterline J, Gallo MF. Effectiveness of erectogenic condom against semen exposure among women in Vietnam: Randomized controlled trial. PLoS One. 2022 Feb 17;17(2):e0263503. doi: 10.1371/journal.pone.0263503. eCollection 2022.
PubMed 35176037
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting CSD500 Use Among Women in Established Relationships
- ClinicalTrials.gov ID
- NCT02934620
- Acronym / sponsor ID
- 2015H0242
- Conditions
- PSA, Unprotected Sex
- Keywords
- pregnancy, condom, HIV, sexually transmitted infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Vietnam, University of North Carolina, Chapel Hill
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Globally, women in established relationships remain at risk for unintended pregnancy and sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the proposed research, unmet need for contraception is substantial as reflected in the nation's high abortion ratio. Married women account for about one-third of HIV cases in Vietnam, and among this group, most were exposed to the virus through sexual activity with their husband. Condoms will remain crucial for prevention for some time to come. Sustained condom use, however, is notoriously difficult to achieve. A key barrier to the consistent use of condoms is their effect on sexual pleasure. Although sexual pleasure is a primary motivation for engaging in sex and is an integral part of overall sexual health, most programs to improve sexual health operate within a pregnancy and disease-prevention paradigm. A new condom, CSD500, containing an erectogenic drug was developed for use among healthy couples to improve sexual pleasure by increasing penile firmness, size and erection duration. The overall objective of the proposed two-arm randomized trial is to test whether promoting the novel condom CSD500 for improved sexual pleasure results in couples having less unprotected vaginal sex. Investigators will measure the occurrence of unprotected vaginal sex by testing women's vaginal fluid for the presence of prostate-specific antigen (PSA), an objective, biological marker of recent semen exposure. Investigators will randomize 500 adult, heterosexual, monogamous couples, comprised of a total of 1000 individuals, in Thanh Hoa province, Vietnam to receive either CSD500 for sexual pleasure or the standard condom currently provided only for pregnancy and disease prevention to patients during routine care. Study staff will interview female participants at enrollment and after 2, 4, and 6 months and their male partners at the 6-month visit. Study clinicians will sample vaginal fluid from female participants at all visits to test for the presence of PSA.
Detailed description
This randomized controlled trial will test whether promoting the novel condom CSD500 (Futura Medical Developments; Surrey, UK) for improved sexual pleasure results in couples having less unprotected vaginal sex - measured with a biological marker of recent semen exposure - compared to the promotion of a standard condom for disease and pregnancy prevention. CSD500 contains an erectogenic drug and was developed to improve sexual pleasure by increasing penile firmness, size, and erection duration.
Investigators will recruit eligible, monogamous, heterosexual couples at Thanh Hoa Provincial Centre of Reproductive Health in Vietnam to participate in a randomized controlled trial (RCT) of two balanced arms of approximately 250 heterosexual couples each, for a total of 500 couples, comprised of 1000 individuals. At enrollment and at three follow-up visits scheduled at 2, 4 and 6 months after enrollment, study staff will provide condom counseling, will collect vaginal swabs to test for the semen biomarker, prostate-specific antigen (PSA), and will administer a questionnaire to the female participants on their demographics, sexual and condom-related attitudes and practices, including sexual pleasure and perceptions of partner's sexual pleasure. Although the intervention is directed to the women, couples will be enrolled to ensure that the male partners consent to CSD500 use. After enrollment, male participants will not participate in study visit activities, including data collection, until the time of their female partner's final 6-month visit. Because of the differences in counseling messages, participants and study staff at the site cannot be blinded to arm assignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSD500 Condom | Experimental | Device: CSD500 Condom, Behavioral: Condom CounselingReceive CSD500 condoms with condom counseling to use them for sexual pleasure. |
| Standard Condom | Active comparator | Device: Standard Condom, Behavioral: Condom CounselingReceive the standard condom with condom counseling to use them for pregnancy and disease prevention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Not currently using a modern contraceptive method other than condoms or intending to start using a modern contraceptive method other than condoms in the next 6 months;
- Willing to use assigned study condoms as the sole method of contraception for the next six months;
- Not breastfeeding;
- Not known to be pregnant;
- Want to avoid pregnancy for at least the next six months; and
Key exclusion criteria (5 listed)
- Couples are ineligible for study participation if either person in the couple is known to be HIV-positive or has any of the following contraindications to CSD500 use:
- History of low blood pressure or heart condition;
- Current use of medication for anemia, blood pressure, erectile dysfunction, migraines, headaches or glaucoma;
- Inflamed or broken skin that the condom could come into contact with; or
- Latex allergy or sensitivity.
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 |
|---|---|---|
| CSD500 CondomAlso: Blue DiamondCSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. | Device | CSD500 Condom |
| Standard CondomThe standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. | Device | Standard Condom |
| Condom CounselingThe intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure. | Behavioural | CSD500 Condom, Standard Condom |
Primary outcome
Number of Female Participants With Positive PSA at 2-Month Visit
Time frame: Vaginal swab collected at 2-month follow-up visit
A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.
Number of Female Participants With Positive PSA at 4-Month Visit
Time frame: Vaginal swab collected at 4-month follow-up visit
A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.
Number of Female Participants With Positive PSA at 6-Month Visit
Time frame: Vaginal swab collected at 6-month follow-up visit
A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.
6 secondary outcomes
Number of Female Participants With Self-reported Condomless Sex at 2-month Follow-up Visit
Time frame: Measured at 2-month follow-up visit
Quality of Sexual Experience (QSE) Scale Scores Among Participants at 6-month Visit
Time frame: Measured among participants at at 6-month follow-up visit
Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 2-month Visit
Time frame: Measured among female participants at at 2-month follow-up visit
Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 4-month Visit
Time frame: Measured among female participants at at 4-month follow-up visit
Number of Female Participants With Self-reported Condomless Sex at 4-month Follow-up Visit
Time frame: Measured at 4-month follow-up visit
Number of Female Participants With Self-reported Condomless Sex at 6-month Follow-up Visit
Time frame: Measured at 6-month follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35176037Nguyen NC, Luong TN, Le VT, Hobbs M, Andridge R, Casterline J, Gallo MF. Effectiveness of erectogenic condom against semen exposure among women in Vietnam: Randomized controlled trial. PLoS One. 2022 Feb 17;17(2):e0263503. doi: 10.1371/journal.pone.0263503. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Maria Gallo, PhD principal investigator
Ohio State University
John Casterline, PhD principal investigator
Ohio State University
Rebecca Andridge, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSD500 Condom, Standard Condom and Condom Counseling in people with PSA and Unprotected Sex, run by Ohio State University at 1 site in Vietnam.
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 6 inclusion and 5 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 13 Dec 2024. 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 Vietnam. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Female Participants With Positive PSA at 2-Month Visit (time frame: Vaginal swab collected at 2-month follow-up visit). The study lists 3 primary outcomes in all. 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 NCT02934620, 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 13 Dec 2024.