Pathogenesis of Functional Hypothalamic Amenorrhea

University of Pittsburgh

Status: Completed

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

Treatments: Behavioral: Cognitive behavior therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01674426

MH50748

Details and patient eligibility

About

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.

Full description

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

Enrollment: 17 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups, including a placebo group

Cognitive behavior therapy

Experimental group

Description:

Cognitive behavior therapy consisting of 16 sessions over 20 weeks

Treatment:

Behavioral: Cognitive behavior therapy

observation

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Cognitive behavior therapy