CLINICAL TRIALS PROFILE FOR LUTREPULSE KIT

All Clinical Trials for LUTREPULSE KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01457703 ↗	Reproductive Hormonal Alterations in Obesity	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	2010-06-01	The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined. --Hypotheses: 1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women) 2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)
NCT01457703 ↗	Reproductive Hormonal Alterations in Obesity	Completed	University of Colorado, Denver	N/A	2010-06-01	The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined. --Hypotheses: 1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women) 2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)
NCT01976728 ↗	LutrePulse Hypogonadotropic Hypogonadism	Completed	Ferring Pharmaceuticals	Phase 3	2014-04-01	To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo
NCT03142893 ↗	Hormonal Mechanisms of Sleep Restriction - Axis Study	Active, not recruiting	Los Angeles Biomedical Research Institute	Phase 1	2017-05-08	The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.

Clinical Trial Conditions for LUTREPULSE KIT

Condition Name

Condition Name for LUTREPULSE KIT
Intervention	Trials
Sleep Restriction	2
Primary Amenorrhea With Hypogonadotropic Hypogonadism	1
Obesity	1

Condition MeSH

Condition MeSH for LUTREPULSE KIT
Intervention	Trials
Hypogonadism	1
Amenorrhea	1
Obesity	1

Clinical Trial Locations for LUTREPULSE KIT

Trials by Country

Trials by Country for LUTREPULSE KIT
Location	Trials
United States	25
Canada	2

Trials by US State

Trials by US State for LUTREPULSE KIT
Location	Trials
California	3
Colorado	2
Virginia	1
Utah	1
Texas	1

Clinical Trial Progress for LUTREPULSE KIT

Clinical Trial Phase

Clinical Trial Phase for LUTREPULSE KIT
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for LUTREPULSE KIT
Clinical Trial Phase	Trials
Completed	2
Recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for LUTREPULSE KIT

Sponsor Name

Sponsor Name for LUTREPULSE KIT
Sponsor	Trials
Los Angeles Biomedical Research Institute	2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1

Sponsor Type

Sponsor Type for LUTREPULSE KIT
Sponsor	Trials
Other	5
Industry	1
NIH	1