Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

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Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

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All Drugs and Chemicals

Androgens

Testosterone

Ganirelix

Hormones

Hormone Antagonists

Test the efficacy of Ganirelix administered subcutaneously at single-dose regimen of 0.0625 mg in 10 women with PCOS, in rectifying LH pulse frequency and LH amplitude

Test the efficacy of Ganirelix administered subcutaneously at single-dose regimen of 0.025 mg in 10 women with PCOS, in rectifying LH pulse frequency and LH amplitude.

An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.0625 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h.

An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.025 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h.

Sophie Catteau-Jonard, MD,PhD

The clinical study using a sub-therapeutic dose of a GnRH antagonist to reduce overactive LH pulsatility in women with PCOS. With the intervention and lowered LH action we anticipate to decrease androgen levels in women with PCOS. The aim to show for the first time that low-dose GnRH-antagonists can lower LH pulsatility by 20-30% and decrease androgen levels without blunting the hypothalamic-pituitary-gonadal axis and thereby the reproductive functions.

Patients followed in endocrine gynecology consultation in the Jeanne de Flandre department

Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.

Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions

The degree of gonadotropin suppression will be determined by calculating the percent inhibition from the pre-antagonist period \[(mean PRE - nadir)/mean PRE\] x 100, where nadir hormone levels will be calculated using a moving average.

defined by the difference between the measurement at H8 and the measurement at H0 (4 hours before injection) of total testosterone and androstenedione.

defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of FSH

defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of estradiol

defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of AMH.

University Hospital, Lille

Diseases and Abnormalities at or Before Birth

Infertility

Azoospermia

Klinefelter Syndrome

Testicular Neoplasms

Hypogonadism

Oligospermia

Infertility, Male

Genital Diseases, Male

Male Urogenital Diseases

Chromosome Disorders

Disorders of Sex Development

Sex Chromosome Disorders

Congenital Abnormalities

Urogenital Abnormalities

Genetic Diseases, Inborn

Antineoplastic Agents

Gastrointestinal Agents

Herbal and Botanical

Methyltestosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Castor Oil

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Laxatives

Cathartics

Castor

Testosterone undecanoate 1000mg injection at baseline (0-week), 6-week, 18-week, 30-week

Injection 4 ml of castor oil at baseline (week-0), week-6, week-18, week-30

Testosterone undecanoate 1000mg (in 4 ml of castor oil injections) at baseline (0-week), 6-week, 18-week, 30-week

4 ml of Castor Oil injected at baseline (0-week), 6-week, 18-week, 30-week.

Andrea Lenzi, MD

Andrea Isidori, MD, PhD

Vincenzo Bonifacio, MD, PhD

Patients with infertility often presents alterations at ultrasonographic examination of the testis. These alterations include a much higher incidence of small, multiple, non-palpable hypoechoic micro-nodules that can show internal vascularization. This finding often create alarm and anxiety, because it has to be placed in a differential diagnosis versus low-stage malignant germ cell tumors. Nevertheless, explorative surgery reveal that a consistent number of these lesion are benign, due to Leydig cell hyperplasia or Leydig cell tumours. The purpose of this study is to evaluate the effects of androgen therapy on the size and number of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin levels.

Patients with the testicular dysgenesis syndrome, that comprises a variable spectrum of clinical manifestations, such as infertility, cryptorchidism, hypospadias, impaired spermatogenesis and testicular germ cell neoplasms, often develop alterations in the Leydig cell compartment. These alterations range from abnormal localization and clustering to hyperplasia or tumorous formation.

Leydig cell tumors (LCTs), although uncommon in the general population, are the most frequent non-germ cell testicular neoplasms, and their incidence has been reported increasingly growing, especially in infertile patients. Given that the focal areas of Leydig cell hyperplasia are nowadays easily detectable at ultrasonography of the testis (US), as small non-palpable hypoechoic micro-nodules that can show internal vascularization, their finding create a diagnostic challenge versus low-stage malignant germ cell tumors.

Patients with testicular dysgenesis syndrome in general exhibit an elevation of Follicle-Stimulating Hormone (FSH), but in these patients, very frequently, even Luteinizing Hormone (LH) is above the reference range. The latter can work as a growth factor for Leydig cells. Since exogenous testosterone can suppress LH levels, it could be that androgen therapy could revert the LH-induced growth stimulation of Leydig cell compartment.

The purpose of this study is to evaluate the effects of androgen therapy on the size and number of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin levels.

The purpose of this study is also to evaluate whether the behavior (UltraSonographic appearance, US) of the non-palpable hypoechoic micro-nodules during a 4-month trial of testosterone therapy can offer a novel diagnostic tool in the differential diagnosis of benign versus malignant testicular nodules.

The trial will be open only for patients with multiple non-palpable hypoechoic micro-nodules that have an elevation of both FSH and LH and that are not seeking conception.

Participants in the study will be randomized to one of two treatment groups, receiving either testosterone undecanoate (low-dose androgen) or placebo, for two 6 months. All participants will be evaluated for safety at the beginning of the study and at 2, 4, and 6 months with careful history, physical examination, blood sampling and testicular ultrasonography. Patients will also be offered the possibility to perform Magnetic Resonance Imaging (MRI) of the testis at baseline and after treatment, and/or surgical enucleation of the lesions.

Androgen for Leydig Cell Proliferation

Androgen Treatment in Leydig Cell Proliferation

Percentage change of the area of the lesions multiplied by the number of the measured lesions: \[(area_1 + area_2 + area_3 + ... + area_n)\*n\].

The latter measure account for reduction in the number of lesions (disappearance).

Percentage change in the area of the lesion (measured with computer assisted graphics).

Reduction of the serum Luteinizing Hormone (LH) levels during testosterone therapy

Evaluation of sperm cell production after testosterone withdrawal.

Changes in the number of areas / nodules / lesions in the long-term safety assessment

University of Roma La Sapienza

Professor of Endocrinology

4 x 7 ml of blood punction at each control visit of the three trimesters of pregnancy

Plasma dosage

Immediately following delivery (\<12h postpartum), placental biopsies (Collection of 4 placental fragments)

placental biopsy

sophie Jonard, MD,PhD

Polycystic ovary syndrome (PCOS) is the most common cause of ovulation disorders and affects 10 to 15% of women. Despite its frequency, its physiopathology remains unknown.

In women, Anti-Müllerian hormone (AMH) is secreted by granulosa cells located in the ovaries within the follicles. Compared to control women, serum AMH level is higher in PCOS women and could play a role in its pathophysiology. The severity of the PCOS phenotype is correlated with the production of AMH.

It is currently described in the literature that daughters of women with PCOS have a 50% risk of developing PCOS, but no genetic cause of transmission is known. In mice (article in press), pregnant females injected with AMH give birth to offspring with PCOS symptoms. The AMH could thus also play a role in the heritability of PCOS in women. Our team demonstrated that AMH, in its active cleaved form, had a direct central action on the hypothalamus by increasing the pulsatility of GnRH, inducing LH hypersecretion. The hypothesis is that AMH remains higher in pregnant women with PCOS and may affect the fetus by altering fetal and maternal hypothalamic secretions or by modifying placental steroid production.

Leptin has a role in reproduction, through its receptors located at the central (hypothalamus) and peripheral (granulosa cells) levels. In excessively high serum concentration, as observed in obesity, it would lead to a dysregulation of GnRH secretion, an alteration of ovarian steroidogenesis and a dysregulation of folliculogenesis.

Will be compare leptin levels in first trimester patients with and without PCOS to look for possible correlations between AMH and leptin and eliminate possible bias.

Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin

Oligomenorrhea

Anti-Inflammatory Agents

Antiemetics

Reproductive Control Agents

Dexamethasone

Dexamethasone acetate

Chorionic Gonadotropin

Glucocorticoids

Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.

Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

Intervention: Each subject in the Oligomenorrhea group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.

Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.

recombinant human chorionic gonadotropin (r-hCG)

R. Jeffery Chang, M.D.

In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.

In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU.We propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.

Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)

Assess serum levels of 17OHP after stimulation with recombinant hCG

Assess seruim levels of testosterone after stimulation with recombinant hCG

Assess serum levels of androstenedione after stimaultion with recombinant hCG

Assess serum levels of DHEA after stimulation with recombinant hCG

University of Virginia

University of California, San Diego

Principal Investigator

The number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events should be 24

PCOS Group

Normal Group

Oligomenorrhea Group

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Oligpomenorrhea subjects not part of study

Dr. R. Jeffrey Chang

17OHP Levels After hCG

Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

.

Oligpmenrreha group not included in study

Oligomenorreha group not inlcuded in study

Androstenedione

Oligomenrrhea group not included in study

DHEA

Intervention: Each subject in the PCOS group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

Dexamethasone: Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.

recombinant human chorionic gonadotropin (r-hCG): Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection

Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

Dexamethasone

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.	NCT05751252	Polycystic Ovar...	Ganirelix Ganirelix	18 Years - 35 Years	University Hospital, Lille
Androgen for Leydig Cell Proliferation	NCT01206270	Klinefelter Syn... Hypergonadotrop... Hypergonadotrop... Hypergonadotrop...	Testosterone un... Castor Oil	18 Years - 60 Years	University of Roma La Sapienza
Androgen for Leydig Cell Proliferation	NCT01206270	Klinefelter Syn... Hypergonadotrop... Hypergonadotrop... Hypergonadotrop...	Testosterone un... Castor Oil	18 Years - 60 Years	University of Roma La Sapienza
Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin	NCT03483792	Polycystic Ovar...	Plasma dosage placental biops...	18 Years - 43 Years	University Hospital, Lille
Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)	NCT01154192	PCOS	Dexamethasone recombinant hum...	12 Years - 18 Years	University of California, San Diego
Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin	NCT03483792	Polycystic Ovar...	Plasma dosage placental biops...	18 Years - 43 Years	University Hospital, Lille

Spots Global Cancer Trial Database for lh

Every month we try and update this database with for lh 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 lh

Every month we try and update this database with for lh 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 lh 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.