Pathogenesis of Functional Hypothalamic Amenorrhea

University of Pittsburgh17 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Cognitive behavior therapyBEHAVIORAL

16 sessions of 45 minutes each to review stress management

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

UPittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: Change before and after 20 weeks of CBT or observation

Secondary Outcomes

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

Time frame: Change before and after 20 weeks of CBT or observation

Data from ClinicalTrials.gov

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