Clinical trials: Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
This study is researching an experimental drug called mibavademab (also called "study drug"). The study is focused on participants with a condition called Functional Hypothalamic Amenorrhea (FHA).
- Trial name
- KYRIAD (NCT07235917)
- Testing
- Mibavademab
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Regeneron Pharmaceuticals
Polycystic Ovary Syndrome, Hypothalamic Amenorrhea
Body Fat as Determinant of Female Gonadal Dysfunction
Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis.
- Trial name
- NCT03841981
- Testing
- Anthropometric and physical examination, Indirect calorimetry, accelerometer and seven-day dietary recall, Biochemical, hormonal and metabolic phenotyping
- Where
- Spain
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Bone Strength, Bone Density
Role of Estrogen on Skeletal Outcomes in FHA
The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen…
- Conditions
- Bone Strength, Bone Density, FHA (Functional Hypothalamic Amenorrhea)
- Trial name
- NCT07010146
- Testing
- transdermal 17β-E2 with cyclic progestin, oral 17β-E2 with cyclic progestin, transdermal EE+LNG
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of Virginia
Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA).
- Trial name
- NCT07224438
- Testing
- kisspeptin 112-121
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stephanie B. Seminara, MD
Hypothalamic Amenorrhea
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)
Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial…
- Trial name
- ARCH (NCT05629377)
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Mayo Clinic
Amenorrhea, Functional Hypothalamic Amenorrhea (FHA)
Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea
Functional hypothalamic amenorrhea (FHA) is a condition where women lose their menstrual periods, typically due to a combination of stress and insufficient calorie intake to fuel their daily physical activity (low energy…
- Conditions
- Amenorrhea, Functional Hypothalamic Amenorrhea (FHA), Low Energy Availability, Relative Energy Deficiency in Sport
- Trial name
- NCT07612735
- Testing
- Resistance Training Program
- Where
- Spain
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Catholic University of Murcia
Functional Hypothalamic Amenorrhea
A 10-Week Online Education Program for Women With Functional Hypothalamic Amenorrhea: Developing and Testing Feasibility and Acceptability
This study is a single-arm feasibility trial evaluating a 10-week web-based psychoeducational intervention for women with functional hypothalamic amenorrhea (FHA).
- Trial name
- HEAL FHA Pilot (NCT07589868)
- Testing
- 10-week web-based psychoeducational program
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- Karolinska Institutet
Functional Hypothalamic Amenorrhea
The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
This study aims to validate the efficacy and safety of the "two-step cycle-regulating approach integrating Chinese and Western medicine: rapid restoration of menstruation with Western medicine, and nourish the kidney and soothe…
- Trial name
- NCT07580950
- Testing
- traditional Chinese medicine, Western medicine
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Peking Union Medical College Hospital
FHA (Functional Hypothalamic Amenorrhea)
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation of the menstrual period due to intense exercise, stress, or an eating…
- Trial name
- NCT06533865
- Testing
- Romosozumab, Zoledronic acid
- Where
- 2 sites in United States
- Volunteers
- 114 people
- Sponsor
- Massachusetts General Hospital
Hypothalamic Amenorrhea, Functional
Health and Lifestyle Support for Functional Hypothalamic Amenorrhea
The goal of this clinical trial is to learn whether a 10-week psychoeducational health and lifestyle intervention can help women with Functional Hypothalamic Amenorrhea (FHA) restore their endocrine balance and menstrual cycles.
- Trial name
- HEAL-FHA (NCT07386223)
- Testing
- Psychoeducaction or treatment as usual, Treatment as usual (TAU)
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Karolinska Institutet
Hypothalamic Amenorrhea, Functional, Hypothalamic Amenorrhea
The REgistry of Very Early Estrogen and AnovuLation
The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.
- Conditions
- Hypothalamic Amenorrhea, Functional, Hypothalamic Amenorrhea, Functional Hypogonadotropic Hypogonadism
- Trial name
- REVEAL (NCT06583408)
- Testing
- Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), REVEAL Questionnaire
- Where
- 2 sites in United States
- Volunteers
- 100,000 people
- Sponsor
- Mayo Clinic
Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA).
- Trial name
- KASPR (NCT05633966)
- Testing
- Kisspeptin 112-121
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Stephanie B. Seminara, MD
Hypothalamic Amenorrhea, Functional
Assessment of Nutritional Knowledge, Habits, and Eating Behavior in Athletic Women to Evaluate the Possible Impact on Their Menstrual Function
The present study aims to investigate the degree of knowledge about nutrition and dietary habits in athletic women through validated questionnaires and to evaluate a possible impact on their menstrual function, including women…
- Trial name
- NCT06933888
- Where
- Italy
- Volunteers
- 102 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Estrogen Deficiency, Cardiovascular Disease (CVD)
Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
The purpose of this study is to determine whether young women with functional hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for pre-clinical cardiovascular disease (CVD).
- Conditions
- Estrogen Deficiency, Cardiovascular Disease (CVD), Functional Hypothalamic Amenorrhea, Endothelial Dysfunction
- Trial name
- NCT03018366
- Testing
- 17beta Estradiol, Progesterone
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Kallmann Syndrome, Hypogonadotropic Hypogonadism
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
The purpose of this study is to explore the genetic basis of reproductive disorders and cleft lip and/or palate.
- Conditions
- Kallmann Syndrome, Hypogonadotropic Hypogonadism, Hypothalamic Amenorrhea, Polycystic Ovarian Syndrome
- Trial name
- NCT01601171
- Where
- Switzerland
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Vaudois
Anorexia Nervosa, Hypothalamic Amenorrhea
Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea
The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.
- Conditions
- Anorexia Nervosa, Hypothalamic Amenorrhea, Obesity
- Trial name
- NCT00556036
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Infertility, Hypothalamic Amenorrhea
The Luveris In Vitro Fertilization Trial
The purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period).
- Conditions
- Infertility, Hypothalamic Amenorrhea, Hyperprolactinemia
- Trial name
- NCT00889512
- Testing
- Luveris fixed dose, Luveris increasing dose
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University Reproductive Associates
Hypothalamic Amenorrhea
Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea
The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea.
- Trial name
- NCT02984696
- Testing
- 1 mg of transdermal estradiol daily and 10mg of oral MPA
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Catholic University of the Sacred Heart
Idiopathic Hypogonadotropic Hypogonadism, Hypothalamic Amenorrhea
Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders
In this study, we will measure levels of reproductive hormones and metabolic markers in subjects with isolated GnRH deficiency disorders and compare them to healthy control populations.
- Trial name
- NCT01165619
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital