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Hormone Therapy
Progesterone for Androgen Syndrome during Puberty (CRM003 Trial)
Phase < 1
Recruiting
Led By Christopher R McCartney, M D
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)
Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period
Must not have
Inability/incapacity to provide informed consent
Due to the amount of blood being drawn, adolescent volunteers with body weight < 25 kg will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during first cru admission and during the second cru admission (which occurs at least 2 months after the first)
Awards & highlights
Summary
This trial will study if progesterone affects luteinizing hormone (LH) differently in pubertal girls with or without hyperandrogenism.
Who is the study for?
This trial is for mid- to late pubertal girls with or without hyperandrogenism (HA), which includes conditions like excessive body hair. Participants must be generally healthy, not pregnant, and willing to avoid pregnancy. Girls with HA should have higher than normal testosterone levels or visible signs of hirsutism. Those without HA need normal testosterone levels and no hirsutism.
What is being tested?
The study tests if progesterone can reduce waking luteinizing hormone (LH) frequency more during wakefulness than sleep in girls without HA, and if its effect on LH is less in girls with HA compared to those without. It involves comparing a micronized progesterone suspension against a placebo.
What are the potential side effects?
Possible side effects from the micronized progesterone could include mood swings, headaches, menstrual changes, breast tenderness, bloating, dizziness or allergic reactions among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a girl in the middle to late stages of puberty, not more than 2 years after my first period.
Select...
I am committed to using non-hormonal birth control methods during the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand or sign the consent form.
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I weigh more than 25 kg.
Select...
My kidney function is reduced with a GFR less than 60.
Select...
I have had breast, ovarian, or endometrial cancer in the past.
Select...
I have symptoms that may indicate Cushing's syndrome, adrenal insufficiency, or acromegaly.
Select...
I have signs of increased male hormones, like more body hair, a deeper voice, or enlarged clitoris.
Select...
I have a serious heart or lung condition.
Select...
I have diabetes or my blood sugar/A1c levels are high.
Select...
I am a female.
Select...
My obesity is due to a specific hormonal or genetic condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during first cru admission and during the second cru admission (which occurs at least 2 months after the first)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during first cru admission and during the second cru admission (which occurs at least 2 months after the first)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Luteinizing hormone (LH) pulse frequency
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Micronized progesterone suspensionExperimental Treatment1 Intervention
Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.
Group II: PlaceboPlacebo Group1 Intervention
Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
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Who is running the clinical trial?
University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,261 Total Patients Enrolled
4 Trials studying Puberty
204 Patients Enrolled for Puberty
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,475 Total Patients Enrolled
Christopher R McCartney, M DPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Micronized progesterone suspension
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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