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DHEA (Intrarosa®) for Vaginal Discomfort in Breast Cancer Survivors
Study Summary
This trial is testing the safety and effectiveness of a drug called Intrarosa®, which is used to improve vaginal discomfort. Participants will be randomly assigned to use Intrarosa® once a day or Replens™ two times a week.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have not used any vaginal or intrauterine hormonal products in the last 8 weeks.I do not have any current vaginal infections or diseases.You have stopped having periods for at least 12 months, or for 6 months with high FSH levels, or 6 weeks after surgery to remove ovaries with or without uterus.My breast cancer is in stage I-III and is hormone receptor positive.I haven't used any hormone depot-preparation or implant in the last 6 months.I am undergoing or have undergone surgery or laser treatments for my vulva and vagina.I have unexplained genital bleeding or signs of a pelvic condition that hasn't been checked.I will not change my hormone therapy during the study.I do not have active breast or gynecologic cancer.I cannot undergo a vaginal/speculum exam.I have had radiation to my pelvis or a history of cancer in my reproductive organs.I have not used any androgen or anabolic steroids in the last 6 months.You have severe mental health issues that are not being controlled.I experience symptoms of vaginal dryness or pain during sex.I already use a vaginal lubricant for symptom relief and can continue during the study.I am postmenopausal, had breast cancer, finished primary treatment, and have been on AI for 6+ months.You have had a normal Pap test within the last 12 months.I have not used any over-the-counter estrogen products in the last 6 months.I do not have unexplained genital bleeding.I haven't used any hormonal products like estrogen or progestin in the last 8 weeks.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Vaginal DHEA
- Group 2: Vaginal Polycarbophil Moisturizer
Frequently Asked Questions
What is the verdict on Vaginal Dehydroepiandrosterone from the FDA?
"While there is some evidence suggesting that Vaginal Dehydroepiandrosterone is safe, as this is only a Phase 2 trial, it received a score of 2."
Who does this research require as participants?
"To participate in this trial, women must be between 18 and 70 years old, have neoplasms, and meet the following additional requirements: experience symptoms of vaginal dryness or dyspareunia according to the BSSC-W or FSFI, lack undiagnosed genital bleeding that has not been evaluated by a medical professional."
Are there any unfilled vacancies in this particular clinical trial?
"Yes, this clinical trial is open and presently looking for participants. The listing was created on 6/7/2021 and last updated on 6/8/2022."
What are the most recent findings from other scientific tests involving Vaginal Dehydroepiandrosterone?
"As of now, there are a total of 14 different clinical studies being conducted that focus on Vaginal Dehydroepiandrosterone. 4 of those trials are currently in Phase 3. Most of the research locations for this potential treatment are situated in London and Colorado; however, there are a grand total of 232 sites running these kinds of experiments."
How many people are involved in this experiment?
"Yes. The clinicaltrial.gov website has details about the current recruitment for this study, which began on 6/7/2021. 60 patients are needed at 1 site for this trial."
Could you tell me if this trial is only for patients who are under 60 years old?
"According to the eligibility requirements specified by the study, patients must be aged between 18-70. There are 115 other clinical trials for patients who fall under the age of 18 and 2449 for senior citizens above the age of 65."
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