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Progesterone for Androgen Syndrome during Puberty (CRM003 Trial)
CRM003 Trial Summary
This trial will study if progesterone affects luteinizing hormone (LH) differently in pubertal girls with or without hyperandrogenism.
CRM003 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCRM003 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CRM003 Trial Design
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Who is running the clinical trial?
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- I am unable to understand or sign the consent form.Your body mass index (BMI) is in the lowest 5% for your age, which means you are underweight.You are pregnant or breastfeeding.I am generally healthy, though I may be overweight or have hormone imbalances.I weigh more than 25 kg.There is evidence that your high levels of male hormones or irregular ovulation are caused by something other than a natural condition or polycystic ovary syndrome.My testosterone level is above 150 ng/dl, indicating a possible tumor.My hormone levels suggest I might have a specific adrenal gland condition.I have symptoms suggesting low hormone levels due to stress, diet, or exercise.Your hematocrit level is less than 36% and your hemoglobin level is less than 12 g/dl.Your liver test results are consistently abnormal, except if you have a condition called Gilbert's syndrome, or if you have mild liver enzyme elevations due to obesity, hormonal imbalances, or polycystic ovary syndrome.I haven't taken drugs affecting my hormones, sugar levels, fats, or blood pressure in the last 2 months.Girls with high levels of testosterone in their blood or clear signs of excessive hair growth will not be included.My kidney function is reduced with a GFR less than 60.I have had breast, ovarian, or endometrial cancer in the past.I have been cancer-free for 5 years, except for skin cancer.My thyroid function is abnormal, but I'm not excluded if it's controlled and TSH levels are normal.I, or my guardian, can and will agree to participate in the study.I have symptoms that may indicate Cushing's syndrome, adrenal insufficiency, or acromegaly.I have signs of increased male hormones, like more body hair, a deeper voice, or enlarged clitoris.I have a serious heart or lung condition.It's okay to have a slightly high level of prolactin if you have a condition called HA/PCOS, as long as it's not more than 20% higher than the normal limit.You have had an allergic reaction to micronized progesterone in the past.I am a girl in the middle to late stages of puberty, not more than 2 years after my first period.You have very low platelet or white blood cell counts.Girls who do not have high levels of testosterone and do not have excessive body hair.I have diabetes or my blood sugar/A1c levels are high.I am a female.My obesity is due to a specific hormonal or genetic condition.I am committed to using non-hormonal birth control methods during the study.Your DHEA-S levels are more than 1.5 times higher than the normal range. If you are a teenager with a specific condition or have PCOS, some elevation may be allowed.
- Group 1: Micronized progesterone suspension
- Group 2: Placebo
- 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 health issues is Micronized progesterone suspension most frequently utilized to treat?
"Micronized progesterone suspension is a viable treatment for uterine hemorrhage, hormonal imbalances, and the prevention of recurrent preterm birth."
Are volunteers accepted for this experiment at present?
"According to clinicaltrials.gov, this medical experiment is currently recruiting study participants. Originally posted on June 1st 2008 and updated as recently as May 16th 2022, the trial seeks volunteers from around the world."
Have any prior investigations been conducted using Micronized progesterone suspension?
"At present, 42 studies for Micronized progesterone suspension are in progress. 8 of them have reached Phase 3 trials, and 268 sites all over the world are hosting these clinical investigations - with Barcelona, Catalunya being the predominant area."
Is eligibility for this experiment limited to those under the age of 50?
"To be eligible for this medical study, participants must fit into the 10 - 17 age range. 16 sub-studies exist specifically to evaluate children under 18 and 12 are reserved to monitor seniors over 65 years of age."
Do I fulfill the requirements to participate in this clinical experiment?
"This clinical investigation is enrolling 36 pre-pubescent individuals aged between 10 and 17. Eligibility criteria are as follows: Female adolescents in mid to late puberty with breast stage 3, serum free testosterone within the Tanner reference range (and without hirsutism) or higher than said range (with evidence of hirsutism), general health except for obesity, hypothyroidism or hyperandrogenism; capable of informed assent/consent successfully provided; use of reliable non-hormonal contraceptive methods during study duration mandatory."
How many participants have been approved for this medical study?
"Affirmative, clinicaltrials.gov details that this trial is actively enrolling participants at present. It was initially posted on June 1st 2008 and its information most recently updated on May 16th 2022 - the study requires 36 individuals from a single medical centre."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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