NCT00001770

Brief Summary

Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or menopause. Hormone replacement therapy includes both estrogen and progesterone. The estrogen component of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but estrogen also increases the risk of uterine cancer. The progesterone component of the HRT (progestin) works to prevent the increased risk of uterine cancer. There is evidence that some women experience unpleasant mood symptoms (such as irritability, depressed mood and anxiety) while receiving hormone replacement therapy (HRT) while taking the progestin / progesterone component of the HRT. This study is designed to evaluate the ability of progestins to produce negative mood symptoms in women. Researchers intend on doing this by comparing the effects of medroxyprogesterone acetate (Provera) and a placebo inactive sugar pill. Patient's moods will be monitered based on their response to questionnaires answered in the outpatient clinic and at home. This research will attempt to answer the following questions:

  1. 1.Are progestins associated with changes in mood during hormone replacement therapy?
  2. 2.If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 1998

Longer than P75 for all trials

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

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Depressive DisorderMood DisorderPsychomotor Agitation

Keywords

DepressionEstrogenHormone Replacement TherapyMoodProgestinProgesteroneAnxiety

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The subjects in this study will be women who meet the following criteria:
  • history of mood and/or behavioral symptoms associated with hormone replacement therapy;
  • age 40 to 65;
  • in good medical health.

You may not qualify if:

  • Any subject with significant physical, EKG, mammogram or laboratory abnormalities will not participate in this protocol. Additionally prior to participation all subjects will be examined for any contradictions to estrogen therapy (as determined by a pelvic exam and mammogram) within the past year by a gynecologist of their choice. In those patients who are unable to independently arrange this exam, we have arranged for a consultant gynecologist to be available through our collaboration with NICHD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Wagner KD. Major depression and anxiety disorders associated with Norplant. J Clin Psychiatry. 1996 Apr;57(4):152-7.

    PMID: 8601550BACKGROUND

  • Smith RN, Holland EF, Studd JW. The symptomatology of progestogen intolerance. Maturitas. 1994 Feb;18(2):87-91. doi: 10.1016/0378-5122(94)90046-9.

    PMID: 8177097BACKGROUND

  • Magos AL, Brewster E, Singh R, O'Dowd T, Brincat M, Studd JW. The effects of norethisterone in postmenopausal women on oestrogen replacement therapy: a model for the premenstrual syndrome. Br J Obstet Gynaecol. 1986 Dec;93(12):1290-6. doi: 10.1111/j.1471-0528.1986.tb07868.x.

    PMID: 3801360BACKGROUND

MeSH Terms

Conditions

Depressive DisorderMood DisordersPsychomotor AgitationDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental DisordersDyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 1, 1998

Study Completion

March 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-03

Locations

US(1)