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Polycystic Ovary Syndrome

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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46, XX Disorders of Sex Development

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Estradiol 3-benzoate

Polyestradiol phosphate

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Flutamide

Estrogens

Hormones

Hormone Antagonists

Progestins

Androgen Antagonists

Antineoplastic Agents, Hormonal

For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.

Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.

Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.

Subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day.

oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days

estrace

Christopher R. McCartney, MD

The purpose of this study is to understand the effects of elevated male hormones in adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If the investigators understand the effects of elevated male hormones levels in girls, the investigators may be able to better treat girls with elevated male hormone levels and perhaps even learn how to prevent the development of PCOS. Females with elevated levels of male hormones respond differently to estrace (estradiol) and progesterone than females with normal male hormone levels. The investigators will be giving you estrogen and progesterone to see how you respond after the male hormone has been blocked by a medication called flutamide.

Similar to women with PCOS, girls with hyperandrogenemia have an increased frequency of LH pulses when compared to age matched controls. An ongoing study by our group is investigating whether the progesterone insensitivity of the GnRH pulse generator in adult women with PCOS is also seen in adolescent girls with hyperandrogenemia. Analysis of the data to date suggests that the hyperandrogenic adolescent girls have decreased hypothalamic progesterone sensitivity when compared to adolescent controls, with a subgroup (consisting of approximately half of the hyperandrogenic girls) having marked progesterone insensitivity similar to that seen in adult women with PCOS. These data have recently been published.

Given that androgens mediate hypothalamic progesterone insensitivity in adult women with PCOS, we hypothesize that androgens play a similar role in adolescent girls with hyperandrogenemia and that progesterone sensitivity can be restored with the use of the androgen receptor blocker flutamide.

Better understanding the effects of hyperandrogenemia in adolescence and its role in the development of PCOS will hopefully lead to improved prevention and treatment strategies for PCOS. This may prove increasingly important if the current epidemic in childhood obesity results in a growing number of girls with elevated androgen levels.

Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

Effect of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenic Adolescent Girls (JCM021)

The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Virginia

Principal investigator Center for Research in Reproduction

For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.

Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.

Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.

Flutamide: Subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day.

Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days

estrace: 0.5-1 mg once a day for seven days

Flutamide, Estrace, Progesterone

Age, Categorical

Age, Continuous

Sex: Female, Male

White

Race/Ethnicity, Customized

United States

Region of Enrollment

Clinical Research Coordinator

One subject completed the study but had not taken the study medication so her data is unusable. The second subject completed the study. However, no data were formally analyzed. We were subsequently unable to recruit any additional subjects.

Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level

Overall Study

Estrace, 0.5-1 mg once a day Micronized progesterone powder (Spectrum Chemical Manufacturing Corporation, Irving, CA), Three times a day at 0700, 1500, and 2300 hr

20 mg/ml, 25-100 mg, Three times a day at 0700, 1500, and 2300 hr for 7 days

Chris McCartney, MD

Girls with high levels of the male hormone testosterone often develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. Women with PCOS also have difficulty becoming pregnant. Some, girls with high levels of male hormone will develop normal hormone levels as they grow up. Most girls continue to have high levels of male hormone as adults. In addition, girls with elevated levels of male hormones often have lower fertility rates in adulthood. In this study the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls and women with the goal of understanding how and why some girls and women have higher levels of male hormone and the causes of PCOS. If investigators understand the causes of these disorders, they may be able to better treat them and perhaps even learn how to prevent the development of PCOS.

Adolescent hyperandrogenemia (excess androgen production) occurring before or during early puberty appears to be a precursor to adult polycystic ovary syndrome (PCOS). PCOS affects about 6% of women of childbearing age in the United States. Those who suffer from this disorder often experience irregular menstrual periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of infertility. Women with PCOS often report irregular menstrual cycles as adolescents. A study of adolescents with menstrual irregularities showed that some subjects normalize endocrine function as they mature, while a majority maintained hyperandrogenism in conjunction with high levels of luteinizing hormone (LH) and polycystic ovaries. In addition, girls with high levels of serum androgens often have lower fertility rates in adulthood.

We propose that adult PCOS, and perhaps adolescent hyperandrogenemia, are due in part to dysregulation of pituitary and ovarian hormones. Synthesis and secretion of LH and follicle stimulating hormone (FSH) are primarily regulated by gonadotropin releasing hormone (GnRH). Both LH and FSH are secreted by the same gonadotrope cell, and the frequency of stimulation of this cell by GnRH in part determines which hormone is released. In primates, rapid GnRH frequencies (approx. 1 pulse/ hour) favor LH secretion whereas slower GnRH stimuli (1 pulse/ 3 hours or less) favor FSH release. In normal women, the cyclical rise and fall in hormone levels control follicular maturation and ovulation. Early studies showed an initial predominance of FSH in the follicular phase, with a subsequent rise in estradiol (E2). In the late follicular phase, LH increases as a consequence of increased GnRH secretion. Following ovulation, rising levels of E2 and P then reduce GnRH pulse frequency, allowing a rise in FSH for the next cycle of follicular maturation.

One feature of adult PCOS is increased mean serum levels of LH and increased LH pulse frequency, presumably due to increased stimulation of the pituitary by excess hypothalamic secretion of GnRH. Since women with PCOS maintain high levels of LH and low levels of FSH, follicle maturation and ovulation do not occur normally. Girls with hyperandrogenemia in adolescence also have an increased frequency of LH pulses when compared to age matched controls.

If hyperandrogenemic adolescents could be treated effectively before or during pubertal maturation, development of clinical PCOS as an adult could potentially be avoided. One proposed cause of both hyperandrogenemia and PCOS is a defect in GnRH pulse modulation, which normally happens as puberty progresses. GnRH is secreted by a part of the brain called the hypothalamus. In normal pubertal maturation the increase in GnRH pulse secretion during sleep stimulates LH and ovarian E2 and P secretion. Feedback of these hormones reduces GnRH pulses during daytime hours, initiating cycles of ovarian-hypothalamic feedback regulation which mature into the patterns seen in normal ovulatory cycles. Recent studies have shown that E2 and P can slow LH pulses in adult women with PCOS, but higher concentrations of P are needed to inhibit LH pulse frequency. If hypothalamic (GnRH pulse generator) sensitivity to inhibition by P is reduced during pubertal maturation, the low levels of P present during the initial development of ovarian cyclicity may not be adequate to suppress GnRH/LH pulse secretion. This could lead to LH excess and relative FSH deficiency. Administering oral doses of P in early adolescence may compensate and restore normal ovarian-hypothalamic feedback. In turn, increasing amounts of naturally secreted P in subsequent cycles could eventually normalize the system.

The long term goal of this line of investigation is to determine if E2 and P treatment of adolescents with hyperandrogenemia can slow the GnRH pulse generator to promote FSH production and the advent of normal menstrual cycles. As an initial step we propose to determine if the GnRH pulse generator is relatively insensitive to E2 and P inhibition in hyperandrogenemic adolescent girls.

Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition

Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Normal and Hyperandrogenemic Adolescent Girls (JCM010)

Center for Research in Reproduction

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anastrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered

Estrace 10 mg three times daily will be administered for 3 months.

Estrace

After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment

Claudine Isaacs, M.D.

This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.

Prior to the current standard of care utilizing estrogen deprivation or antiestrogen therapy to treat hormonally sensitive breast cancers, treatment with pharmacologic doses of estrogen was a common technique used to treat post-menopausal women with hormone sensitive metastatic disease that resulted in durable responses with regression of disease. A randomized trial comparing tamoxifen and pharmacologic doses of estrogen demonstrated similar rates of response with long-term follow-up data confirming a survival benefit for those treated with the estrogen preparation. Additional data has shown that post-menopausal women with hormonally sensitive tumors that have progressed on prior endocrine therapies responded to treatment with pharmacologic doses of estrogen. These data, coupled with pre-clinical data that postmenopausal levels of estrogen can be used to cause apoptosis (programmed cell death within the tumor) and tumor regression in exhaustively treated endocrine resistant disease form the rationale for the proposed clinical trial. This trial seeks to confirm the response rate for estrace treatment in a patient population heavily pre-treated with modern endocrine therapies.

Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy

A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies

Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause

Response rate was defined per RECIST version 1.0. In this study, response rate was defined as including patients with either a complete response (complete disappearance of all target lesions with changes confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met) or a partial response (at least 30% decrease in the sum of the longest diameter of the target lesions)

Georgetown University

Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered

Estrace: Estrace 10 mg three times daily will be administered for 3 months.

Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone	NCT01428193	Polycystic Ovar... Hyperandrogenis...	Flutamide Progesterone estrace	13 Years - 17 Years	University of Virginia
Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition	NCT01425541	Hyperandrogenem... Polycystic Ovar...	estrace Progesterone	8 Years - 18 Years	University of Virginia
Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy	NCT00661531	Breast Cancer Cancer of the B... Neoplasms, Brea...	Estrace Anastrozole	18 Years -	Georgetown University

Spots Global Cancer Trial Database for estrace

Every month we try and update this database with for estrace cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for estrace

Every month we try and update this database with for estrace cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for estrace cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.