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Pathogenesis of Functional Hypothalamic Amenorrhea

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01674426
First received: August 14, 2012
Last updated: August 24, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Disorder of Endocrine Ovary
Hypersecretion; Cortisol
Metabolic Disturbance
Stress, Psychological
 Behavioral: Cognitive behavior therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pathogenesis of Functional Hypothalamic Amenorrhea

Resource links provided by NLM:

MedlinePlus related topics: Stress
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • ovarian function [ Time Frame: Change before and after 20 weeks of CBT or observation ] [ Designated as safety issue: No ]
    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:
  • metabolism [ Time Frame: Change before and after 20 weeks of CBT or observation ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • psychological inventories [ Time Frame: Change before and after 20 weeks of CBT or observation ] [ Designated as safety issue: No ]
    Attitudes were assessed before and after 20 weeks of CBT or observation using psychological inventories


Enrollment: 17
Study Start Date: November 1997
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavior therapy
Cognitive behavior therapy consisting of 16 sessions over 20 weeks
 Behavioral: Cognitive behavior therapy
16 sessions of 45 minutes each to review stress management
Placebo Comparator: observation
Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674426

Locations
United States, Pennsylvania
UPittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Emory University
Investigators
Principal Investigator: Sarah L Berga, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01674426     History of Changes
Other Study ID Numbers: MH50748
Study First Received: August 14, 2012
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
functional hypothalamic amenorrhea
stress induced anovulation

Additional relevant MeSH terms:
Amenorrhea
Stress, Psychological
Ovarian Diseases
Menstruation Disturbances
Pathologic Processes
 Behavioral Symptoms
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013