Pathogenesis of Functional Hypothalamic Amenorrhea

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01674426

Enrollment

Registered

2012-08-28

Start date

1997-11-30

Completion date

2003-08-31

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

functional hypothalamic amenorrhea, stress induced anovulation

Brief summary

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.

Detailed description

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

Interventions

BEHAVIORALCognitive behavior therapy

16 sessions of 45 minutes each to review stress management

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ovarian function	Change before and after 20 weeks of CBT or observation	The change in ovarian function was assessed by comparing ovarian function before and after 20 weeks of CBT or observation using menses and serial estradiol and progesterone level as indices of ovarian function

Secondary

Measure	Time frame	Description
metabolism	Change before and after 20 weeks of CBT or observation	The change in metabolism was assessed by measuring levels of cortisol, TSH, T4, free T4, T3, free T3, leptin in blood and by measuring weight before and after 20 weeks of CBT or observation

Other

Measure	Time frame	Description
psychological inventories	Change before and after 20 weeks of CBT or observation	Attitudes were assessed before and after 20 weeks of CBT or observation using psychological inventories

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026