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Pathogenesis of Functional Hypothalamic Amenorrhea

Primary Purpose

Disorder of Endocrine Ovary, Hypersecretion; Cortisol, Metabolic Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavior therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Endocrine Ovary focused on measuring functional hypothalamic amenorrhea, stress induced anovulation

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UPittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cognitive behavior therapy

observation

Arm Description

Cognitive behavior therapy consisting of 16 sessions over 20 weeks

Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed

Outcomes

Primary Outcome Measures

ovarian function
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
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

Full Information

First Posted
August 14, 2012
Last Updated
June 28, 2017
Sponsor
University of Pittsburgh
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01674426
Brief Title
Pathogenesis of Functional Hypothalamic Amenorrhea
Official Title
Pathogenesis of Functional Hypothalamic Amenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Endocrine Ovary, Hypersecretion; Cortisol, Metabolic Disturbance, Stress, Psychological
Keywords
functional hypothalamic amenorrhea, stress induced anovulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavior therapy
Arm Type
Experimental
Arm Description
Cognitive behavior therapy consisting of 16 sessions over 20 weeks
Arm Title
observation
Arm Type
Placebo Comparator
Arm Description
Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Intervention Description
16 sessions of 45 minutes each to review stress management
Primary Outcome Measure Information:
Title
ovarian function
Description
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
Time Frame
Change before and after 20 weeks of CBT or observation
Secondary Outcome Measure Information:
Title
metabolism
Description
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
Time Frame
Change before and after 20 weeks of CBT or observation
Other Pre-specified Outcome Measures:
Title
psychological inventories
Description
Attitudes were assessed before and after 20 weeks of CBT or observation using psychological inventories
Time Frame
Change before and after 20 weeks of CBT or observation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L Berga, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14556820
Citation
Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5.
Results Reference
result
PubMed Identifier
28453773
Citation
Kawwass JF, Sanders KM, Loucks TL, Rohan LC, Berga SL. Increased cerebrospinal fluid levels of GABA, testosterone and estradiol in women with polycystic ovary syndrome. Hum Reprod. 2017 Jul 1;32(7):1450-1456. doi: 10.1093/humrep/dex086.
Results Reference
derived
PubMed Identifier
23507474
Citation
Michopoulos V, Mancini F, Loucks TL, Berga SL. Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized, controlled trial. Fertil Steril. 2013 Jun;99(7):2084-91.e1. doi: 10.1016/j.fertnstert.2013.02.036. Epub 2013 Mar 16.
Results Reference
derived

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Pathogenesis of Functional Hypothalamic Amenorrhea

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