Pathogenesis of Functional Hypothalamic Amenorrhea

Not Applicable

Completed

• Conditions: Hypersecretion; Cortisol; Metabolic Disturbance; Stress, Psychological; Disorder of Endocrine Ovary
• Interventions: Behavioral: Cognitive behavior therapy

• Registration Number: NCT01674426
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 1997-11
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-24
• Study First Posted: 2012-08-28
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavior therapy	Cognitive behavior therapy	Cognitive behavior therapy consisting of 16 sessions over 20 weeks
observation	Cognitive behavior therapy	Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UPittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States