CLINICAL TRIAL

Micronized progesterone suspension for Hyperandrogenism

Stage III
Recruiting · < 18 · Female · Charlottesville, VA

This study is evaluating whether a hormone may help reduce the frequency of waking luteinizing hormone (LH) in girls with high levels of luteinizing hormone (LH).

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About the trial for Hyperandrogenism

Eligible Conditions
Puberty · Hyperandrogenism

Treatment Groups

This trial involves 2 different treatments. Micronized Progesterone Suspension is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Micronized progesterone suspension
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

Eligibility

This trial is for female patients aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
with no current signs or symptoms of puberty A pre-pubertal girl who has not yet undergone any changes to her breasts or genitals is considered to be in Tanner stage 1 of puberty show original
by physical examination For girls with hyperandrogenism: if their serum (calculated) free testosterone concentration is greater than the Tanner stage-specific reference range and they have unequivocal evidence for hirsutism by physical examination, then they have hyperandrogenism. show original
, acne, and/or clitoromegaly For girls without an excess of testosterone: the serum testosterone concentration is within the Tanner stage-specific reference range and the absence of hirsutism, acne, and/or clitoromegaly is observed. show original
General good health (excepting overweight, obesity, hyperandrogenism, and adequately-treated hypothyroidism)
to participating in a research study Adolescents under 16 years old are capable of and willing to provide informed assent to participating in a research study show original
, 97% of the women in the study group did not become pregnant show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: During first CRU admission and during the second CRU admission (which occurs at least 2 months after the first)
Screening: ~3 weeks
Treatment: Varies
Reporting: During first CRU admission and during the second CRU admission (which occurs at least 2 months after the first)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: During first CRU admission and during the second CRU admission (which occurs at least 2 months after the first).
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Micronized progesterone suspension will improve 1 primary outcome in patients with Hyperandrogenism. Measurement will happen over the course of During first CRU admission and during the second CRU admission (which occurs at least 2 months after the first).

Luteinizing hormone (LH) pulse frequency
DURING FIRST CRU ADMISSION AND DURING THE SECOND CRU ADMISSION (WHICH OCCURS AT LEAST 2 MONTHS AFTER THE FIRST)
LH pulse frequency while awake vs. while asleep pulse frequency
DURING FIRST CRU ADMISSION AND DURING THE SECOND CRU ADMISSION (WHICH OCCURS AT LEAST 2 MONTHS AFTER THE FIRST)

Who is running the study

Principal Investigator
C. M.
Prof. Chris McCartney, Associate Professor of Medicine
University of Virginia

Patient Q & A Section

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

Can hyperandrogenism be cured?

A very clear-cut cure for hyperandrogenism cannot be achieved. However, in selected cases it is possible to reduce levels to below the level of masculinization. It is also possible to prevent other clinical manifestations of hyperandrogenism without eliminating the increased sex hormone production.

Anonymous Patient Answer

What are the signs of hyperandrogenism?

We found that women diagnosed with hyperandrogenism presented with varied symptoms which may be more common in women with a higher BMI, overweight, or PCOS. Symptoms were more likely to develop when BMI > 25 or more and PCOS present and included menstrual irregularity, amenorrhea, and painful menstruation. The presence of other conditions, especially PCOS, has an effect on the severity of the symptoms.

Anonymous Patient Answer

How many people get hyperandrogenism a year in the United States?

Approximately 500,000 women in the United States are diagnosed with hyperandrogenism yearly. Hyperandrogenism is more common in women than men, with nearly 70% of the cases of hyperandrogenism reported in women.

Anonymous Patient Answer

What are common treatments for hyperandrogenism?

This review identifies common, long-acting, low-dose medications such as androgens, progestogen, and long-acting estrogens as effective treatment for women with hirsutism and hyperandrogenism. It also points to the need for better standardizing hirsutism treatments and ensuring that women are informed of the common hirsutism treatments before undergoing treatment.

Anonymous Patient Answer

What causes hyperandrogenism?

Hyperandrogenism is most likely due to the interplay of hormones at the pituitary-gonadal axis. This hypothesis needs to be tested in longitudinal studies. If substantiated, it may suggest that the development of polycystic ovary syndrome is initiated in utero.

Anonymous Patient Answer

What is hyperandrogenism?

Hyperandrogenism is a condition that occurs in females as well as males when testosterone and/or estrogen levels are above normal levels. Symptoms may include acne, hirsutism, weight gain, and an enlarged male pelvis called gynecomastia. Hyperandrogenism can occur with congenital adrenal hyperplasia in a proportion of cases. It is often treated with estrogen therapy. The condition was formerly called "polycystic ovary syndrome". Hyperandrogenism can occur with hyperprolactinemia, polycystic ovary syndrome or in women taking the prescription hormone contraceptive pill.

Anonymous Patient Answer

What does micronized progesterone suspension usually treat?

Progestogen-deposition rates achieved with the three micronized doses were similar and were markedly higher than those achieved with other dosage forms. The most consistent dose resulting in maximal progestogen-deposition was 6.5 mg/day micronized.

Anonymous Patient Answer

What are the common side effects of micronized progesterone suspension?

Progesterone as given by subdermal suspension is generally well tolerated. The side effects were mostly mild and infrequent. The common side effects, however, were the same as for subdermal progesterone, and therefore can be expected to occur from a formulation of progesterone taken by subcutaneous injection, rather than from a particular subdermal suspension.

Anonymous Patient Answer

What is micronized progesterone suspension?

The progesterone micronized suspension is well tolerated and effective in the treatment of premenopausal women with hyperandrogenism. The safety of the micronized preparation must be confirmed against oral dosage forms.

Anonymous Patient Answer

Is micronized progesterone suspension safe for people?

The injection of micronized progesterone is well tolerated when used for 12 weeks and is not associated with a decreased incidence of endometrial transformation or other progestogen-associated side effects.

Anonymous Patient Answer

Has micronized progesterone suspension proven to be more effective than a placebo?

A three-week regimen of 3.75 mg/d Provera in postmenopausal women demonstrated a higher mean total serum estradiol level and a corresponding significant reduction in serum DHEAS than a placebo. Results from a recent paper provide further impetus for the addition of a P (micronized) formulation to future comparative effectiveness studies for the treatment of hot flushes following menopause.

Anonymous Patient Answer

Does micronized progesterone suspension improve quality of life for those with hyperandrogenism?

This prospective study showed that the use of MPA at 1.5 mg/d as an intrauterine method had a positive impact on QoL, with a measurable improvement in sexual function. These data demonstrate that MPA may be a safe and effective therapeutic option in the treatment of hyperandrogenism for women, particularly for women without symptoms of menstrual irregularity.

Anonymous Patient Answer
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