Sexual DysfunctionNCT06868121
AYA OMGYES Sexual Health Study
A study testing OMGYES.com in people with Sexual Dysfunction, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of the web-based intervention OMGYES.com on sexual dysfunction in young adult (YA) female-bodied cancer survivors. This pilot trial seeks to evaluate the intervention's: feasibility acceptability appropriateness. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- OMGYES.com
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 45 years
- Diagnosis of cancer between the ages of 15 and 45
- Female genitalia, regardless of gender
- Diagnosed with sexual dysfunction
- Complete Remission and at least two months from a major treatment
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Ability to participate in study modules and to respond to surveys
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients receiving other investigational agents
- Patients expected to be neutropenic or have a significantly high infection risk that would exclude them from vaginal penetration
- Patients who are unable complete the study intervention or surveys
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Hospital
Chicago, Illinois, 60637
Adam DuVall, MD
About this study
Official title: Assessing the Impact of a Web-based Educational Program on the Sexual Health Outcomes of Young Adult Female Cancer Survivors ~ A Pilot Trial
The purpose of this study is to assess the impact of the web-based intervention OMGYES.com on sexual dysfunction in young adult (YA) female-bodied cancer survivors. This pilot trial seeks to evaluate the intervention's:
- feasibility
- acceptability
- appropriateness.
Researchers will utilize an active observation period to compare outcomes between those receiving the intervention immediately and those who haven't
Participants will:
- Complete online modules at home
- Visit the clinic every 5 weeks for questionnaires
- Conditions
- Sexual Dysfunction
- Being tested
- OMGYES.com
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMGYES.comOther
OMGYES.com is an interactive website that offers information, video tutorials, interviews, tips, and resources to explore female sexual pleasure through groundbreaking research that's told through the real-life experiences of women of all ages and life stages.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Intervention | Other | The delayed intervention group will initially undergo 5 weeks of active observation prior to intervention administration. Receives: Other: OMGYES.com |
| Immediate Intervention | Experimental | The immediate intervention group will be administered the intervention at study enrollment. Receives: Other: OMGYES.com |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM)
The Feasibility of Intervention Measure (FIM) is a validated questionnaire that utilizes a 5-point Likert scale to evaluate the extent at which an intervention can be successfully used in a clinical setting.
Measured: End of Study (Week 6)
Secondary outcomes (2)
Acceptability of OMGYES.com using the Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) is a validated questionnaire that utilizes a 5-point Likert scale to evaluate the extent to which participants deem an intervention agreeable, palatable, or satisfactory.
Measured: End of Study (Week 6)
Appropriateness of OMGYES.com using the Appropriateness of Intervention Measure
The Acceptability of Intervention Measure (AIM) is a validated questionnaire that utilizes a 5-point Likert scale to evaluate the perceived fit, relevance, or compatibility of an intervention for a given population; and/or perceived fit of the intervention to address a particular issue or problem
Measured: End of Study (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start16 Jan 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam DuVall, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868121
- Sponsor's protocol ID
- IRB24-0909
- Status last verified
- May 2026
- First submitted
- 26 Feb 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Web-based Educational Program on the Sexual Health Outcomes of Young Adult Female Cancer Survivors ~ A Pilot Trial
- ClinicalTrials.gov ID
- NCT06868121
- Acronym / sponsor ID
- IRB24-0909
- Conditions
- Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- 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.
The purpose of this study is to assess the impact of the web-based intervention OMGYES.com on sexual dysfunction in young adult (YA) female-bodied cancer survivors. This pilot trial seeks to evaluate the intervention's:
- feasibility
- acceptability
- appropriateness.
Researchers will utilize an active observation period to compare outcomes between those receiving the intervention immediately and those who haven't
Participants will:
- Complete online modules at home
- Visit the clinic every 5 weeks for questionnaires
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Intervention | Other | Other: OMGYES.comThe delayed intervention group will initially undergo 5 weeks of active observation prior to intervention administration. |
| Immediate Intervention | Experimental | Other: OMGYES.comThe immediate intervention group will be administered the intervention at study enrollment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18 to 45 years
- Diagnosis of cancer between the ages of 15 and 45
- Female genitalia, regardless of gender
- Diagnosed with sexual dysfunction
- Complete Remission and at least two months from a major treatment
Key exclusion criteria (3 listed)
- Patients receiving other investigational agents
- Patients expected to be neutropenic or have a significantly high infection risk that would exclude them from vaginal penetration
- Patients who are unable complete the study intervention or surveys
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 |
|---|---|---|
| OMGYES.comOMGYES.com is an interactive website that offers information, video tutorials, interviews, tips, and resources to explore female sexual pleasure through groundbreaking research that's told through the real-life experiences of women of all ages and life stages. | Other | Delayed Intervention, Immediate Intervention |
Primary outcome
Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM)
Time frame: End of Study (Week 6)
The Feasibility of Intervention Measure (FIM) is a validated questionnaire that utilizes a 5-point Likert scale to evaluate the extent at which an intervention can be successfully used in a clinical setting.
2 secondary outcomes
Acceptability of OMGYES.com using the Acceptability of Intervention Measure (AIM)
Time frame: End of Study (Week 6)
Appropriateness of OMGYES.com using the Appropriateness of Intervention Measure
Time frame: End of Study (Week 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Related trials for Sexual Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
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.
Adam DuVall, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMGYES.com in people with Sexual Dysfunction, run by University of Chicago 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassandra Kuissi, BS (7737021220, cassandra.kuissi@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM) (time frame: End of Study (Week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.