Your session is about to expire
← Back to Search
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)
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
CRM008 Trial 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.Check my eligibility
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.See study design
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.
CRM008 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am committed to using non-hormonal birth control during the study.
Select...
I am a girl in the middle to late stages of puberty, not more than 2 years after my first period.
CRM008 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Luteinizing hormone (LH) pulse frequency
Side effects data
From 2022 Phase 2 trial • 23 Patients • NCT0405132069%
Hot flashes
62%
Fatigue
54%
Headache
46%
Spotting
46%
Dizziness
31%
Irritability
31%
Emotional sensitivity
23%
Anxiety
23%
Bloating
23%
Arm soreness (Lupron IM injection)
23%
Gastrointestinal upset
23%
Weight gain
15%
Depressed mood
15%
General musculoskeletal pain
15%
Early insomnia
15%
Low back pain
15%
Cramps
15%
Migraine
15%
Anhedonia
8%
Occular migraine
8%
Fever (COVID-19 infection)
8%
Anosmia (COVID-19 infection)
8%
Dry cough (Seasonal allergies)
8%
Mood swings
8%
Intrusive thoughts
8%
Concussion
8%
Breast tenderness
8%
Decreased appetite
8%
Difficulty concentrating
8%
Hormonal acne
8%
COVID-19 Infection
8%
Low libido
8%
Insomnia
8%
Heartburn
8%
Hematoma (IM injection)
8%
Yeast infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormone Sensitive Women (HS+)
Hormone Insensitive Women (HS-)
CRM008 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
2020
Completed Phase 4
~1580
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,041 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,527 Total Patients Enrolled
Christopher R McCartney, M.D.Principal InvestigatorUniversity of Virginia Center for Research in Reproduction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have signs of increased male traits like more body hair, deeper voice, or enlarged clitoris.My prolactin levels are more than 20% above the normal limit.Your liver test results are consistently abnormal, except for mild elevations in bilirubin due to Gilbert's syndrome, or mild elevations in transaminases due to obesity, hypothyroidism, or polycystic ovary syndrome.My hormone levels suggest I might have a specific adrenal gland condition.You have signs of high levels of male hormones or irregular ovulation that are not caused by normal body functions or polycystic ovary syndrome.I am unable to understand or sign the consent form.My obesity is due to a specific hormonal or genetic condition.My testosterone level is above 150 ng/dl, indicating a possible tumor.I do not have serious heart or lung problems.I am generally healthy, though I may be overweight or have treated thyroid issues.I, or my guardian, can and will agree to participate in the study.My kidney function is reduced with a GFR under 60.I have been cancer-free for 5 years, except for skin cancer.I have had breast, ovarian, or endometrial cancer in the past.Your hematocrit level is consistently below 36% and your hemoglobin level is consistently below 12 g/dl.You have very low platelet or white blood cell counts.I might have Cushing's syndrome, adrenal insufficiency, or acromegaly based on my symptoms or doctor's exam.I have diabetes or my blood sugar/A1c levels are high.My thyroid function is abnormal, but I'm not excluded if it's treated and stable.I haven't taken drugs affecting my hormones, sugar levels, fats, or blood pressure in the last 2 months.I am a girl in the middle to late stages of puberty, not more than 2 years after my first period.I am committed to using non-hormonal birth control during the study.Your DHEA-S levels are significantly higher than the normal range, except for mild elevations seen in adolescent HA and in PCOS.I weigh more than 25 kg.You have had an allergic reaction to micronized progesterone or spironolactone in the past.Your body size is smaller than most people your age.I have symptoms suggesting low sex hormone levels due to issues with my brain signaling.I am a female.You have high levels of testosterone in your blood or clear signs of excessive hair growth.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Spironolactone
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which medical condition is Micronized progesterone most often used to treat?
"Micronized progesterone is frequently prescribed to patients suffering from edema. However, it can also help people with primary hyperaldosteronism, female infertility, and certain therapeutic procedures."
Answered by AI
Are we enrolling volunteers for this research project at this time?
"Yes, according to the most recent update on clinicaltrials.gov, this trial is still recruiting patients. The study was initially posted on 21 July 2016, and the latest update was on 16 May 2022. Currently, the study is enrolling 32 participants from 1 site."
Answered by AI
Is there previous research on the effects of Micronized progesterone?
"Out of the 72 ongoing studies investigating Micronized progesterone, 16 are in Phase 3. Some of the trials for Micronized progesterone are running out of in Charlottesville, Virginia, there are 547 locations operating trials for Micronized progesterone."
Answered by AI
Are patients who are 55 years or older allowed to participate in this research project?
"38 other clinical trials are also recruiting patients that are under 18 years old and 35 are for patients over the age of 65. The specific age range that this trial is looking for is between 10-17 years old."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger