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Search / Trial NCT00001770

Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Trial Information

Current as of May 09, 2025

Completed

Keywords

Depression Estrogen Hormone Replacement Therapy Mood Progestin Progesterone Anxiety

ClinConnect Summary

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 eff...

Gender

FEMALE

Eligibility 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.

About National Institute Of Mental Health (Nimh)

The National Institute of Mental Health (NIMH) is a leading federal agency dedicated to advancing the understanding and treatment of mental health disorders through innovative research and clinical trials. As part of the National Institutes of Health (NIH), NIMH focuses on a broad spectrum of mental health issues, including mood disorders, anxiety disorders, schizophrenia, and developmental disorders. By fostering collaboration among researchers, clinicians, and the community, NIMH aims to translate scientific discoveries into effective interventions and improve mental health outcomes for individuals across the lifespan. Through its commitment to rigorous research methodologies and ethical standards, NIMH plays a pivotal role in shaping the future of mental health care and policy.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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