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Completed

NCT Number: NCT01674426

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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

16 sessions of 45 minutes each to review stress management

Primary outcomes

  1. ovarian function

    Time frame: 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 outcomes

  1. metabolism

    Time frame: 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 outcomes

  1. psychological inventories

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Emory University

Registry information

Important dates

Study start
1997
Primary completion
2003
Study completion
2003
First posted
Aug 28, 2012
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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