Is NCT03401047 recruiting in Charlottesville, VA?

Yes, NCT03401047 is currently recruiting participants at its Charlottesville, VA location. This polycystic ovary syndrome clinical trial is actively enrolling qualified participants.

Is participation in this Charlottesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Polycystic Ovary Syndrome Clinical Trial in Charlottesville, VA

Q: How do I join the polycystic ovary syndrome clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Who Can Participate

Inclusion Criteria

PCOS group: post-pubertal (\> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and/or laboratory evidence of hyperandrogenism (hirsutism and/or elevated serum \[calculated\] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and/or ovulatory dysfunction

Control group: post-pubertal (\> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum \[calculated\] free testosterone concentration)

General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism)

Capable of and willing to provide informed consent

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

Exclusion Criteria

Inability/incapacity to provide informed consent

Males will be excluded (hyperandrogenism is unique to females)

Age \< 18 years (we do not propose to study children because we have no preliminary data that would support this particular study in children)

Age \> 30 years (since ovarian reserve may decrease beyond age 30)

Obesity resulting from a well-defined endocrinopathy or genetic syndrome

Positive pregnancy test or current lactation

Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and/or anovulation

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

Total testosterone \> 150 ng/dl, which suggests the possibility of virilizing ovarian or adrenal tumor

DHEA-S greater than upper reference range limit for controls; and DHEA-S elevation \> 1.5 times the upper reference range limit for PCOS. Mild elevations may be seen in PCOS, and will be accepted in this group.

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.

Abnormal thyroid stimulating hormone (TSH): Note that subjects with stable and adequately treated primary hypothyroidism, reflected by normal TSH values, will not be excluded.

Hyperprolactinemia: Any degree of hyperprolactinemia (confirmed on repeat) will be grounds for exclusion for subjects without PCOS. Hyperprolactinemia \> 20% higher than the upper limit of normal will be grounds for exclusion for subjects without PCOS. Mild prolactin elevations may be seen in PCOS, and elevations within 20% higher than the upper limit of normal will be accepted in this group.

History and/or physical exam findings suggestive of Cushing's syndrome, adrenal insufficiency, or acromegaly

History and/or physical exam findings suggestive of hypogonadotropic hypogonadism (e.g., symptoms of estrogen deficiency) including functional hypothalamic amenorrhea (which may be suggested by a constellation of symptoms including restrictive eating patterns, excessive exercise, psychological stress, etc.)

Persistent hematocrit \< 36% and hemoglobin \< 12 g/dl

Severe thrombocytopenia (platelets \< 50,000 cells/microliter) or leukopenia (total white blood count \< 4,000 cells/microliter)

Previous diagnosis of diabetes, fasting glucose \> or = 126 mg/dl, or a hemoglobin A1c \> or = 6.5%

Persistent liver panel abnormalities, with two exceptions. Mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Also, mild transaminase elevations may be seen in obesity/PCOS; therefore, elevations \< 1.5 times the upper limit of normal will be accepted in these groups.

Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure, asthma requiring intermittent systemic corticosteroids, etc.)

Decreased renal function evidenced by GFR \< 60 ml/min/1.73m2

A personal history of breast, ovarian, or endometrial cancer

History of any other cancer diagnosis and/or treatment (with the exception of basal cell or squamous cell skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years

History of allergy to transdermal estradiol patches

BMI \< 18 or \> 40 kg/m2; BMI \< 18 kg/m2 is considered to be underweight, while \> 40 kg/m2 is considered to be class 3 obesity -- both may have marked confounding effects for the outcomes of interest

Menstrual cycles lasting fewer than 26 days: Cycle frequency \< 26 days suggest the possibility of relatively short follicular phases (e.g., \< 12 days). If a subject with a follicular phase shorter than 12 days participates in Aim 1c, they could experience an endogenous gonadotropin surge under surveillance. Since we wish to capture only experimentally-induced surges, we will exclude such subjects.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT03401047) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Polycystic Ovary Syndrome Treatment Options in Charlottesville, VA

If you're searching for polycystic ovary syndrome treatment options in Charlottesville, VA, this clinical trial (NCT03401047) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced polycystic ovary syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all polycystic ovary syndrome clinical trials near you to find additional studies recruiting in your area.

Polycystic Ovary Syndrome Clinical Trial in Charlottesville, VA

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