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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01674426
Other study ID # MH50748
Secondary ID
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
Health authority
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

Study Design


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
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