Pathogenesis of Functional Hypothalamic Amenorrhea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- ovarian function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cognitive behavior therapy
Cognitive behavior therapy consisting of 16 sessions over 20 weeks
Intervention: Cognitive behavior therapy (Behavioral)
observation
Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed
Intervention: Cognitive behavior therapy (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- metabolism(Change before and after 20 weeks of CBT or observation)
Investigators
Sarah Berga
Professor
University of Pittsburgh