Pathogenesis of Functional Hypothalamic Amenorrhea

Stress, Psychological Clinical Trial

Official title:

Pathogenesis of Functional Hypothalamic Amenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674426
• Other study ID #: MH50748
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: June 28, 2017
• Start date: November 1997
• Est. completion date: August 2003

Study information

• Verified date: June 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Amenorrhea
• Disorder of Endocrine Ovary
• Hypersecretion; Cortisol
• Metabolic Disturbance
• Ovarian Diseases
• Stress, Psychological

Intervention

Behavioral:
• Cognitive behavior therapy
16 sessions of 45 minutes each to review stress management

Locations

Country	Name	City	State
United States	UPittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Emory University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	psychological inventories	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
Primary	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	Change before and after 20 weeks of CBT or observation
Secondary	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	Change before and after 20 weeks of CBT or observation