ClinicalTrials.gg
RecruitingNCT06868121Updated Jun 5, 2026

AYA OMGYES Sexual Health Study

An interventional study of OMGYES.com in Sexual Dysfunction, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by University of Chicago · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

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
02

Conditions studied

  • Sexual Dysfunction
03

In context

Sexual Dysfunction, Physiological

385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the 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 document

Exclusion criteria

Exclusion Criteria:

  • Patients receiving other 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Delayed Intervention

    The delayed intervention group will initially undergo 5 weeks of active observation prior to intervention administration.

    Other: OMGYES.com

  • Experimental
    Immediate Intervention

    The immediate intervention group will be administered the intervention at study enrollment.

    Other: OMGYES.com

Interventions

  • OtherOMGYES.com

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: End of Study (Week 6)

Secondary outcomes

  1. 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.

    Time frame: End of Study (Week 6)

  2. 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

    Time frame: End of Study (Week 6)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Aug 2026, 18 months after the start.

Of 100 non-industry interventional studies with no phase under Sexual Dysfunction, Physiological, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 18 months is close to that.

Counting every sponsor, half of 112 studies reached it within 20 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2025
First posted
Mar 10, 2025
StartActual
Jan 16, 2025
Primary completionEst.
Aug 1, 2026
CompletionEst.
Nov 1, 2026
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06868121
Responsible party
Sponsor
First posted
Mar 10, 2025
Start date
Jan 16, 2025
Primary completion
Aug 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Jun 5, 2026

Study contacts

Cassandra Kuissi, BS
Contact
cassandra.kuissi@bsd.uchicago.edu
7737021220
Adam DuVall, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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