Recruiting

Sexual Health

Sponsor:

University of Chicago

Code:

NCT06868121

Conditions

Sexual Dysfunction

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

OMGYES.com

Study Details

Brief 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

Conditions

Sexual Dysfunction

Study ID

NCT06868121

Start date

Jan 16, 2025

Status verified date

May, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Delayed Intervention

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

experimental: Immediate Intervention

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

Interventions

OMGYES.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.

Primary outcome measure

  • Feasibility of OMGYES.com using the Feasibility of Intervention Measure (FIM) [ Time Frame: End of Study (Week 6) ]

Central Contacts and Locations

Central contacts

Cassandra Kuissi, BS

7737021220cassandra.kuissi@bsd.uchicago.edu

Locations

University of Chicago Hospital

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

Adam DuVall, MD

More Information

Sponsor

University of Chicago

Last update posted

Jun 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-06-05.