Know Cancer

or
forgot password

The Phenomenology and Biophysiology of Progestin-Induced Dysphoria


N/A
N/A
N/A
Not Enrolling
Female
Depressive Disorder, Mood Disorder, Psychomotor Agitation

Thank you

Trial Information

The Phenomenology and Biophysiology of Progestin-Induced Dysphoria


There is evidence in the literature that some women experience dysphoric symptoms while
receiving hormone replacement therapy (HRT) and that this disturbance in mood is related to
the progestin component of the HRT. The bulk of this evidence is anecdotal. While some
authors have attempted to examine this putative problem in a more systematic fashion, there
are no controlled studies that attempt to identify the mechanism through which the
perturbation in mood occurs. Adverse effects of progestins might be mediated directly
through the progesterone or androgen receptor. Alternatively, the effects of progestins
might be consequent to the antiestrogen effects of progesterone. This latter possibility is
in part supported by our observation in previous studies of the beneficial effects of
estradiol on mood and the possible precipitation of mood disturbance following acute
estrogen withdrawal. Finally, despite the popular lore that progesterone causes mood
disturbances, a placebo effect cannot be ruled out, since women taking HRT know when they
are receiving the progestin component of the regimen. Our research questions therefore are
as follows: 1) Are progestins associated with changes in mood during HRT, and 2) If
progestins are associated with mood disturbance, is it because they are blocking the
beneficial effects of estrogen?

Inclusion Criteria


INCLUSION CRITERIA

The subjects in this study will be women who meet the following criteria:

1. history of mood and/or behavioral symptoms associated with hormone replacement
therapy;

2. age 40 to 65;

3. in good medical health.

EXCLUSION CRITERIA

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.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

980079

NCT ID:

NCT00001770

Start Date:

March 1998

Completion Date:

March 2003

Related Keywords:

  • Depressive Disorder
  • Mood Disorder
  • Psychomotor Agitation
  • Depression
  • Estrogen
  • Hormone Replacement Therapy
  • Mood
  • Progestin
  • Progesterone
  • Anxiety
  • Depressive Disorder
  • Depression
  • Psychomotor Agitation
  • Mood Disorders

Name

Location

National Institute of Mental Health (NIMH)Bethesda, Maryland  20892