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Estradiol for Polycystic Ovary Syndrome (CRM009 Trial)
CRM009 Trial Summary
This trial is testing if a hormone can help reduce symptoms in women with polycystic ovary syndrome.
CRM009 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCRM009 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 64 Patients • NCT02255175CRM009 Trial Design
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Who is running the clinical trial?
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- I am a female.I am able and willing to agree to the study's procedures and risks.I am over 30 years old.My hormone levels suggest I might have a specific adrenal gland condition.If you have high levels of prolactin, you may not be able to participate in the study unless you have PCOS. If the prolactin level is more than 20% higher than the normal limit, you may not be able to participate unless you have PCOS.I might have Cushing's syndrome, adrenal insufficiency, or acromegaly based on my symptoms or doctor's exam.My liver tests are mostly normal, but I may have slight increases due to Gilbert's syndrome or if I'm overweight/have PCOS.My BMI is either below 18 or above 40.If your period comes more often than every 26 days, it may mean your body is preparing eggs too quickly, and we do not want that in this study.I have diabetes or my blood sugar or A1c levels are high.I have a serious heart or lung condition.I have been cancer-free for 5 years, except for skin cancer.I am a woman aged 18-30 with PCOS, showing signs of high male hormones and irregular periods.I am a woman aged 18-30, have regular periods, and show no signs of excessive male hormones.You should be healthy overall, unless you are overweight, have obesity, PCOS, or well-managed hypothyroidism.I am unable to understand or sign the consent form.My obesity is due to a specific hormonal or genetic condition.My thyroid function is abnormal, but I'm not excluded if it's treated and stable.My kidney function is reduced with a GFR under 60.I am 18 years old or older.I have symptoms suggesting low hormone levels due to stress, diet, or exercise.You have had an allergic reaction to transdermal estradiol patches in the past.I have had breast, ovarian, or endometrial cancer in the past.Your blood has too few red blood cells and low hemoglobin.You have very low platelet or white blood cell counts.You are pregnant or currently breastfeeding.There are signs of hormone imbalance or irregular periods not caused by PCOS or other common reasons.Your DHEA-S hormone levels are higher than the normal range for healthy people, or more than 1.5 times the normal range for people with PCOS. Some increases in PCOS patients are acceptable for this study.I have signs of increased male traits like more body hair, deeper voice, or enlarged clitoris.My testosterone level is above 150 ng/dl, indicating a possible tumor.I agree to use non-hormonal birth control methods during the study.
- Group 1: Transdermal Estradiol
- 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.
Frequently Asked Questions
What criteria must be met to become eligible for participation in this clinical trial?
"This clinical trial seeks 37 young adult women aged 18-30 with sclerocystic ovaries who exhibit a regular menstrual cycle and no signs of hyperandrogenism. Other eligibility criteria include general good health, aside from being overweight or obese, having PCOS, or adequately treated hypothyroidism. Additionally, participants must agree to utilize reliable non-hormonal birth control methods during the study's duration."
Are there opportunities for new participants in this clinical trial?
"Affirmative. Clinicaltrials.gov states that the scientific trial, initially posted on November 30th 2017, is still open for enrollment. Specifically, 37 individuals from 1 facility need to be recruited for this research project."
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