Pathogenesis of Functional Hypothalamic Amenorrhea

June 28, 2017 updated by: Sarah Berga, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Upittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change before and after 20 weeks of CBT or observation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change before and after 20 weeks of CBT or observation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change before and after 20 weeks of CBT or observation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Emory University

Investigators

  • Principal Investigator: Sarah L Berga, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1997

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 24, 2012

First Posted (Estimate)

August 28, 2012

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH50748

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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