Pathogenesis of Functional Hypothalamic Amenorrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-11-30

Study Completion Date

2003-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women

NCT05967819

Amenorrhea Secondary

RECRUITING NA

Combined Hormone Replacement in Menstrually-Related Mood Disorders

NCT00005011

Premenstrual Syndrome Depression

COMPLETED

The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders

NCT00001232

Depressive Disorder Healthy Mental Disorders +1 more

COMPLETED

Baselines in Reproductive Disorders

NCT00456274

Amenorrhea Hypogonadotropic Hypogonadism Kallmann's Syndrome

UNKNOWN NA

Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)

NCT00001770

Depressive Disorder Mood Disorder Psychomotor Agitation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study enrollment was completed in 2003. The study results are being analyzed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disorder of Endocrine Ovary Hypersecretion; Cortisol Metabolic Disturbance Stress, Psychological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive behavior therapy

Cognitive behavior therapy consisting of 16 sessions over 20 weeks

Group Type EXPERIMENTAL

Cognitive behavior therapy

Intervention Type BEHAVIORAL

16 sessions of 45 minutes each to review stress management

observation

Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed

Group Type PLACEBO_COMPARATOR

Cognitive behavior therapy

Intervention Type BEHAVIORAL

16 sessions of 45 minutes each to review stress management

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive behavior therapy

16 sessions of 45 minutes each to review stress management

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women with functional hypothalamic amenorrhea
* day awake / night asleep schedule

Exclusion Criteria

* eating disorders, depression, excessive exercise or any other cause of amenorrhea and anovulation other than functional hypothalamic amenorrhea
* weight loss greater than 10 pounds when amenorrhea developed
* running more than 10 miles per week or exercising more than 10 hours per week

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No