ClinicalTrials.gov
ClinicalTrials.gov Menu

Pathogenesis of Functional Hypothalamic Amenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01674426
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Sarah Berga, 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.

Condition or disease Intervention/treatment Phase
Disorder of Endocrine Ovary Hypersecretion; Cortisol Metabolic Disturbance Stress, Psychological Behavioral: Cognitive behavior therapy Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pathogenesis of Functional Hypothalamic Amenorrhea
Study Start Date : November 1997
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

Arm Intervention/treatment
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
Behavioral: Cognitive behavior therapy
16 sessions of 45 minutes each to review stress management



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Berga, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01674426     History of Changes
Other Study ID Numbers: MH50748
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Sarah Berga, 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