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Progestin

Hormone Regulation Therapy for Polycystic Ovary Syndrome (CRM008 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

Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period

Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)

Must not have

Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly)

Early morning 17-hydroxyprogesterone > 200 ng/dl measured in the follicular phase, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase, the 17-hydroxyprogesterone will be repeated during the follicular phase). NOTE: If a 17-hydroxyprogesterone > 200 ng/dl is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone < 1000 ng/dl will be required for study participation.

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 is testing if a medication can help reduce hormone levels in girls who are experiencing puberty.

Who is the study for?

This trial is for mid to late pubertal girls with hyperandrogenism, which can be related to conditions like Polycystic Ovary Syndrome. Participants must not be pregnant, avoid pregnancy during the study, and should generally be in good health without significant medical issues affecting their heart, lungs or metabolism.

What is being tested?

The study tests if spironolactone (which blocks androgen receptors) helps progesterone reduce waking luteinizing hormone pulse frequency in adolescent girls with high levels of male hormones. The effectiveness of this combination treatment is compared against a placebo.

What are the potential side effects?

Possible side effects include menstrual irregularities, breast tenderness, headaches, fatigue, gastrointestinal discomfort from progesterone; and for spironolactone: increased urination, electrolyte imbalances, dizziness or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am committed to using non-hormonal birth control during the study.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My hormone levels suggest I might have a specific adrenal gland condition.

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I am unable to understand or sign the consent form.

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My obesity is due to a specific hormonal or genetic condition.

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I do not have serious heart or lung problems.

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My kidney function is reduced with a GFR under 60.

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

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I might have Cushing's syndrome, adrenal insufficiency, or acromegaly based on my symptoms or doctor's exam.

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

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I haven't taken drugs affecting my hormones, sugar levels, fats, or blood pressure in the last 2 months.

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I weigh more than 25 kg.

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I am a female.

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.

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

Side effects data

From 2022 Phase 2 trial • 23 Patients • NCT04051320

69%

Hot flashes

62%

Fatigue

54%

Headache

46%

Dizziness

46%

Spotting

31%

Irritability

31%

Emotional sensitivity

23%

Bloating

23%

Arm soreness (Lupron IM injection)

23%

Gastrointestinal upset

23%

Anxiety

23%

Weight gain

15%

General musculoskeletal pain

15%

Depressed mood

15%

Early insomnia

15%

Low back pain

15%

Cramps

15%

Migraine

15%

Anhedonia

Occular migraine

Fever (COVID-19 infection)

Anosmia (COVID-19 infection)

Dry cough (Seasonal allergies)

Mood swings

Intrusive thoughts

Concussion

Breast tenderness

Decreased appetite

Difficulty concentrating

Hormonal acne

COVID-19 Infection

Low libido

Insomnia

Heartburn

Hematoma (IM injection)

Yeast infection

100%

80%

60%

40%

20%

Study treatment Arm

Hormone Sensitive Women (HS+)

Hormone Insensitive Women (HS-)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SpironolactoneExperimental Treatment2 Interventions

Prior to the first or the second admission (randomly determined), participants will be pretreated for 2 weeks with spironolactone (50 mg twice daily).

Group II: PlaceboPlacebo Group2 Interventions

Prior to the first or the second admission (randomly determined), participants will be pretreated for 2 weeks with placebo (twice daily).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Micronized progesterone

2021

Completed Phase 4

~1730

Placebo

1995