Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04493333

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors

Breast Cancer Female Clinical Trial

Official title:
Comparison of Vaginal Dehydroepiandrosterone (DHEA) to Control for Treatment of Vaginal Symptoms in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors: A Phase II Randomized Trial

Clinical Trial Summary

The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone. By doing this study, the investigators hope to learn if Intrarosa® can improve vaginal discomfort. Participants will be assigned to one of two groups. One group will use Intrarosa® once a day. The other group will use Replens™ two times a week.

Clinical Trial Description

This will be a two-armed, randomized Phase II trial. All study subjects will be asked to fill out a simple 5-question sexual functioning survey. If any concern about sexual functioning is noted, the subject will also be asked to fill out a more extensive Sexual functioning tool, to help determine which domain of sexual functioning is the most bothersome. Subjects who complete the initial screening will be randomly assigned to the Intrarosa® or Replens™ arm by a 1:1 ratio. Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks. At baseline and at 12 weeks, subjects will undergo a physical exam including clinical breast and gynecological exam. During gynecologic exams, the vaginal Potential of Hydrogen (pH) will be determined and a swab of vaginal epithelium sent for determination of the Vaginal Maturation Index (VMI) and Maturation Value (MV). These will be used as objective physiologic markers to determine the improvement in vaginal atrophy. The cytologist's reading specimens will be blinded. Additionally, all study subjects will be asked to fill out questionnaires at baseline and again in 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04493333
Study type Interventional
Source University of Arkansas
Contact
Status Terminated
Phase Phase 2
Start date June 7, 2021
Completion date July 18, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT03080623 - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed NCT05527769 - Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Completed NCT06376578 - Exercise Interventions for Improving Health in Breast Cancer Survivors N/A
Completed NCT03004534 - A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide Early Phase 1
Recruiting NCT05020574 - Microbiome and Association With Implant Infections Phase 2
Active, not recruiting NCT06277141 - The Vitality Mammography Messaging Study N/A
Completed NCT03555227 - USG PECS vs LIA for Breast Cancer Surgery N/A
Completed NCT03270111 - High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women N/A
Active, not recruiting NCT03917082 - Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer Phase 2
Recruiting NCT05561842 - Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
Completed NCT04554056 - Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF Phase 2/Phase 3
Active, not recruiting NCT03127995 - Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence N/A
Active, not recruiting NCT02237469 - Prone Breast Radiotherapy Treatment Planning Observational Study
Completed NCT01204125 - Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients Phase 2
Recruiting NCT04565054 - Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC Phase 3
Not yet recruiting NCT06412133 - Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients N/A
Recruiting NCT03956641 - Evolution of the Physical Condition in Treated Cancer Patients N/A
Recruiting NCT06087120 - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting NCT06058936 - Exercises Using Virtual Reality on Cancer Patients N/A
Completed NCT03470935 - Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger