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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)

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 below

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I am a girl in the middle to late stages of puberty, not more than 2 years after my first period.

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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:

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I am unable to understand or sign the consent form.

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I weigh more than 25 kg.

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My kidney function is reduced with a GFR less than 60.

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I have had breast, ovarian, or endometrial cancer in the past.

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I have symptoms that may indicate Cushing's syndrome, adrenal insufficiency, or acromegaly.

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I have signs of increased male hormones, like more body hair, a deeper voice, or enlarged clitoris.

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I have a serious heart or lung condition.

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I have diabetes or my blood sugar/A1c levels are high.

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I am a female.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during first cru admission and during the second cru admission (which occurs at least 2 months after the first) for reporting.