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New treatment option for Polycystic Ovary Syndrome
Official title Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT03401047
What this study is testing
What is Estradiol?
Estradiol is an investigational medicine, given as an once-daily, being studied as a potential treatment for polycystic ovary syndrome.
Also referred to as Vivelle.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 30, women only. Healthy volunteers may be eligible.
You may be able to join if
- PCOS group: post-pubertal (\> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and/or laboratory evidence of...
- Control group: post-pubertal (\> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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]...
- 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
- 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...
- Abnormal thyroid stimulating hormone (TSH): Note that people 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 people without PCOS. Hyperprolactinemia \> 20% higher than the upper limit of normal will be grounds for...
- 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...
- 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...
- 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...
- History of allergy to transdermal estradiol patches
- BMI \ 40 kg/m2; BMI \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.