NCT01674426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 1997

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

5.8 years

First QC Date

August 14, 2012

Last Update Submit

June 28, 2017

Conditions

Disorder of Endocrine OvaryHypersecretion; CortisolMetabolic DisturbanceStress, Psychological

Keywords

functional hypothalamic amenorrheastress induced anovulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • metabolism

    Change before and after 20 weeks of CBT or observation

Other Outcomes (1)

  • psychological inventories

    Change before and after 20 weeks of CBT or observation

Study Arms (2)

Cognitive behavior therapy

EXPERIMENTAL

Cognitive behavior therapy consisting of 16 sessions over 20 weeks

Behavioral: Cognitive behavior therapy

observation

PLACEBO COMPARATOR

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

Behavioral: Cognitive behavior therapy

Interventions

Cognitive behavior therapyBEHAVIORAL

16 sessions of 45 minutes each to review stress management

Cognitive behavior therapyobservation

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with functional hypothalamic amenorrhea
  • day awake / night asleep schedule

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • 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. doi: 10.1016/s0015-0282(03)01124-5.

    PMID: 14556820RESULT

  • Kawwass JF, Sanders KM, Loucks TL, Rohan LC, Berga SL. Increased cerebrospinal fluid levels of GABA, testosterone and estradiol in women with polycystic ovary syndrome. Hum Reprod. 2017 Jul 1;32(7):1450-1456. doi: 10.1093/humrep/dex086.

    PMID: 28453773DERIVED

  • Michopoulos V, Mancini F, Loucks TL, Berga SL. Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized, controlled trial. Fertil Steril. 2013 Jun;99(7):2084-91.e1. doi: 10.1016/j.fertnstert.2013.02.036. Epub 2013 Mar 16.

    PMID: 23507474DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sarah L Berga, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 28, 2012

Study Start

November 1, 1997

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

US(1)