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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
General good health (excepting overweight, obesity, hyperandrogenism, and adequately-treated hypothyroidism)
Capable of and willing to provide informed assent (adolescents under age 16 years) and/or consent (adolescents over age 16 years; custodial parents or guardians of all adolescent volunteers)
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

CRM003 Trial 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.Check my eligibility
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.See study design
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.

CRM003 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am generally healthy, though I may be overweight or have hormone imbalances.
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I, or my guardian, can and will agree to participate in 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.
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I am committed to using non-hormonal birth control methods during the study.

CRM003 Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Luteinizing hormone (LH) pulse frequency

CRM003 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.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,004 Total Patients Enrolled
4 Trials studying Puberty
204 Patients Enrolled for Puberty
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,760 Total Patients Enrolled
Christopher R McCartney, M DPrincipal InvestigatorUniversity of Virginia

Media Library

Micronized progesterone suspension (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00929006 — Phase < 1
Puberty Research Study Groups: Micronized progesterone suspension, Placebo
Puberty Clinical Trial 2023: Micronized progesterone suspension Highlights & Side Effects. Trial Name: NCT00929006 — Phase < 1
Micronized progesterone suspension (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00929006 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Maine
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Dec 2024