Clinical trials: Functional Hypothalamic Amenorrhea
Hormones
CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study)
Background: Functional hypothalamic amenorrhea (functional HA) is a condition where a woman s period stops for a temporary time. This is due to improper function of the hypothalamus.
- Trial name
- NCT02858336
- Testing
- NEA, DEA
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
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
Disorder of Endocrine Ovary, Hypersecretion; Cortisol
Pathogenesis of Functional Hypothalamic Amenorrhea
This is a randomized pilot study of the use of cognitive behavior therapy versus observation to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.
- Conditions
- Disorder of Endocrine Ovary, Hypersecretion; Cortisol, Metabolic Disturbance, Stress, Psychological
- Trial name
- NCT01674426
- Testing
- Cognitive behavior therapy
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Pittsburgh
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, 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, 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
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
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
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
Amenorrhea Secondary
Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists.
- Trial name
- FHA (NCT05967819)
- Testing
- Exercise Stress, Psychosocial Stress
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Colorado Springs
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
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
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
Menstrual Irregularity
Timing of Energy Availability on Menstrual Cycle Function
The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy…
- Trial name
- FAST (NCT06471582)
- Testing
- Artificially Sweetened Carbohydrate Beverage, Artificially Sweetened Beverage
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Colorado Springs
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
Amenorrhea Secondary
AMH and Functional Hypothalamic Amenorrhea
The purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism…
- Trial name
- AMELIA (NCT05921877)
- Testing
- venous sampling
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Amenorrhea Secondary
Screening Women for Functional Hypothalamic Amenorrhea (FHA)
What do the investigators know already? Many women suffer loss of periods (amenorrhoea). One of the most common causes of period loss is called 'functional hypothalamic amenorrhea' (FHA).
- Trial name
- NCT05410886
- Testing
- Questionnaire
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Imperial College London
Amenorrhea
Study of Leptin for the Treatment of Hypothalamic Amenorrhea
The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive function, hormone levels, immune function…
- Trial name
- NCT00130117
- Testing
- r-metHuLeptin, Oral Contraceptive Pills (OCPs)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Anovulation, FHA
FHA: Characterization of Metabolic Status, Brain Circuitry, and Stress-Reactivity
Functional Hypothalamic Amenorrhea (FHA), the spontaneous cessation of the menstrual cycle for at least 6 months after menstrual cyclicity has been established, is a common and reversible form of anovulation not due to…
- Conditions
- Anovulation, FHA, Eumenorrhea, Polycystic Ovary Syndrome
- Trial name
- NCT00453219
- Testing
- Screening evaluation, Meal Response, Blood Collection
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Emory University
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