Clinical Studies


On this page is a list of all Reproductive Endocrine studies currently recruiting study participants, along with basic qualifications for participating:

Current Studies

Title: Psychology, Behavior and Sex Hormones Study
PI: William F. Crowley
Synopsis: The purpose of this study is to evaluate the role of pubertal exposure of sex hormones on behavior and psychology in humans.

 

 

Title: The Molecular Basis of Inherited Reproductive Disorders (Kallmann Syndrome)
PI: William F. Crowley
Synopsis: The purpose of this study is to learn about the hereditary basis of disorders of the reproductive system including early puberty, late puberty, and complete absence of puberty, and typical puberty that is accompanied by abnormalities of the reproductive system later in life.

 

 

 

Title: The Role of Gonadotropin Pulsations In Reversal Of Hypogonadotropic Hypogonadism
PI: William F. Crowley
Synopsis: The purpose of study is 1) identify men, women and adolescent boys with disorders of GnRH secretion; 2) describe the spectrum of reproductive disorders; and 3) to study the physiology and control of the reproductive system in the human.

 

 

Title: The Role of Prokineticin 2 pathway in regulation of glucose homeostasis in humans
PI: Ravikumar Balasubramanian
Synopsis: The purpose of this study is to examine one of the ways the body may regulate glucose metabolism and the role of Prokineticin 2 in this.

 

 

Title: Disgust processing in Kallmann’s Syndrome
PI: William F. Crowley
Synopsis: The purpose of this study is to understand how individuals with anosmia (individuals with no orpoor sense of smell) recognize and process emotions, in particular disgust.

 

 

Title: The Effects of Seven Days of Exogenous Pulsatile GnRH Treatment on the Pituitary-Gonadal Axis in Hypogonadotropic Hypogonadal Subjects
PI: William F. Crowley
Synopsis: The purpose of this study is to investigate the use of GnRH as a treatment for those with hypogonadotropic hypogonadism.

 

 

Title: Patient Centered Survey of Subjects with GnRH Deficiency
PI: William F. Crowley
Synopsis: The purpose of this study is to identify the support and informational needs of patients with GnRH deficiency and assess the impact of living with GnRH deficiency.

 

 

 

Title: The Role of Sex Steroids in Shaping Sleep Macroarchitecture during Adolescence.
PI: Janet E. Hall, M.D.
Synopsis: The purpose of this research study is to see how reproductive hormones (such as estrogen and testosterone) affect how children sleep. During the night, we pass through different sleep stages, such as rapid eye movement sleep (REM), light sleep, and deep sleep. We know that starting at about 11-12 years of age, children start to have less deep sleep at night. We want to find out if reproductive hormones cause the decrease in deep sleep that we see in adolescents. We also want to know if the body releases more reproductive hormones during deep sleep than during light sleep.

 

 

Title: Investigation of Female Reproductive Hormone Dynamics during Adolescence
PI: Janet E. Hall, M.D.
Synopsis: Many girls have irregular menstrual cycles for several years after they have their first period. An irregular menstrual cycle means that a girl does not get her period once a month, like most adult women do. We want to understand what causes these irregular menstrual cycles. We also want to understand what causes LH and FSH levels to start to go down during sleep. We know that when girls begin to ovulate (release an egg from the ovary), that the ovary starts to release a hormone called progesterone. We think that when progesterone levels go up, LH and FSH levels start to go down during sleep.

 

 

Title: Investigating the Impact of Obesity on pubertal development in girls
PI: Janet E. Hall, M.D.
Synopsis: We are doing this study to find out if overweight girls go through puberty earlier than normal weight girls. There have been some recent reports that overweight girls are developing breast tissue earlier than normal weight girls. However, overweight girls do not seem to be getting their first period any earlier. These studies suggest that overweight girls may be starting puberty earlier but progressing through puberty more slowly than normal weight girls. One problem with previous studies is that doctors decided whether or not a girl had breast tissue by palpating (feeling) the chest. This can be a problem in overweight girls because fatty tissue in the chest can often feel like breast tissue. We think that by using breast ultrasound we can do a better job of telling whether or not an overweight girl has breast tissue. This will help us understand if overweight girls are truly entering puberty before normal weight girls.

 

 

Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Two Doses of Subcutaneous Pulsatile GnRH Administered via OmniPod Pump for Ovulation Induction in Female Subjects with Primary Amenorrhea with Hypogonadotropic Hypogonadism.
PI: Frances J. Hayes, M.D.
Synopsis: We are doing this research study to learn whether using a device called OmniPod to deliver pulses of a synthetic form of gonadotropin-releasing hormone (GnRH) called LutrePulse is effective at causing ovulation in women who have infertility due to primary amenorrhea with hypogonadotropic hypogonadism (HH).

 

 

Title: Neuropeptides in Human Reproduction
PI: Dr. Seminara
Synopsis: The purpose of this study is to see how two other hormones, Kisspeptin and Dynorphin, control the amount of GnRH that our body makes. GnRH is a hormone that is responsible for making estrogen and allowing women to have menstrual cycles, and become pregnant; for males, GnRH is responsible for making testosterone and for fathering children.

 

 

Title: Elucidating Kisspeptin by Blocking Kisspeptin Signaling
PI: Dr. Seminara
Synopsis: Studies in animals have shown that giving kisspeptin for a long period of time (1 day or longer) can cause reproductive hormone levels to temporarily become lower. The goal of this research study is to study the effect of giving kisspeptinfor24 hours to healthy men and women and to patients with reproductive disorders.

 

 

Title: Kisspeptin Physiology in the Human
PI: Dr. Seminara
Synopsis: Kisspeptin is an investigational drug, which means that it is not approved by the U.S. Food and Drug Administration(FDA).At this time, kisspeptin can only be used in research studies.

Kisspeptin is a chemical that is naturally made in the body. It is involved in reproduction, and is made in very high levels in women during pregnancy. Some studies in humans have shown that taking kisspeptin causes the body to produce hormones called gonadotropins (pronounced “go-nad-oh-trope-ins”). Gonadotropins travel through the body in the bloodstream. In men, they cause the testes to produce the male hormone testosterone and to make sperm. In women, they stimulate the ovaries to release an egg.

As part of the study, you will also receive a hormone called GnRH (short for “gonadotropin-rel easing hormone”). GnRH stimulates the pituitary gland to produce gonadotropins and will be given to you to make sure your body is able to respond fully to kisspeptin.