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Hormone Therapy for Polycystic Ovary Syndrome (CRM010 Trial)
CRM010 Trial Summary
This trial is testing if flutamide, a hormone blocker, can help normalize the pituitary gland's function in women with PCOS.
CRM010 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCRM010 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 2011 Phase 4 trial • 115 Patients • NCT00611923CRM010 Trial Design
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Who is running the clinical trial?
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- I might have Cushing's syndrome, adrenal insufficiency, or acromegaly based on my symptoms or doctor's exam.You have very low platelet or white blood cell counts.I have diabetes or my blood sugar/A1c levels are high.You are generally healthy, but being overweight, having obesity, hyperandrogenism, PCOS, or treated hypothyroidism is okay.My kidney function is reduced with a GFR under 60.There is evidence that your high levels of male hormones and irregular periods are caused by something other than a common condition called PCOS.Your DHEA-S hormone levels are more than 1.5 times higher than the normal range. If you have a condition called PCOS and have slightly higher levels, you may still be accepted.My liver function tests are normal.I have signs of increased male traits like more body hair, deeper voice, or enlarged clitoris.I am not allergic to micronized progesterone, flutamide, or transdermal estradiol.I am either younger than 18 or older than 30.I am a woman aged 18-30 and have been menstruating for over 4 years.I have symptoms suggesting low hormone levels due to stress, diet, or exercise.My obesity is due to a specific hormonal or genetic condition.My testosterone level is above 150 ng/dl, indicating a possible tumor.Your prolactin levels are significantly higher than normal, except if you have mild elevations due to PCOS, in which case a small increase is okay.Your blood's thickness (hematocrit) is consistently too low, and you have low hemoglobin levels.My thyroid function is abnormal, but I am not excluded if it's treated and stable.My BMI is either below 18 or above 40.You have signs of a condition called PCOS, which includes having high levels of male hormones and irregular menstrual cycles, and there are no other reasons for these symptoms.I have had breast, ovarian, or endometrial cancer before.My hormone levels suggest I might have a specific adrenal gland condition.I am female.I am unable to understand or sign the consent form.I am committed to using non-hormonal birth control methods during the study.I am able and willing to agree to the study's procedures.I have a serious heart or lung condition.
- Group 1: Placebo
- Group 2: Flutamide
- 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
Is the age requirement for this trial inclusive of geriatric individuals?
"Those wishing to partake in this trial must be aged between 18 and 30 years old. There are an additional 30 slots available for participants below the age of consent, while 45 spots remain open for those over 65."
Am I eligible to enroll in this research study?
"The requirements for eligibility include a diagnosis of sclerocystic ovaries and being within the age range of 18-30 years old. In total, 10 participants will be invited to join this trial."
Are new participants still being admitted into this clinical experiment?
"Per the records on clinicaltrials.gov, this ongoing medical trial is looking for participants as of now. The first posting was on December 20th 2022 and it has been updated most recently on May 16th 2022."
What is the scope of recruitment for this clinical trial?
"Affirmative. On clinicaltrials.gov, we can see that this trial is actively recruiting participants; it was initially posted on December 20th 2022 and last updated in May 16th 2022. The study seeks to enroll 10 patients from one medical site."
What conditions are usually treated with Flutamide?
"Flutamide is often prescribed to those who have not menstruated in the last 6 months, but it also can be employed for other purposes such as alleviating menopausal vasomotor symptoms and treating hypoestrogenism-related breast issues."
Are there any previous investigations involving Flutamide?
"Presently, 97 trials related to flutamide are in progress. 23 of these studies have made it past Phase 2 and into the advanced third phase. Although originating from Cheras Kuala Lumpur, 3222 medical centres around the world are running clinical tests for this drug's efficacy."
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