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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00227942

NCT00227942
Completed Phase 4

Who may be able to join

Who might be able to join this trial:

  • You are going through or have already been through menopause (either naturally or due to surgery)
  • If you had surgery to remove your uterus but kept one or both ovaries, you may still qualify if a specific hormone level in your blood (FSH) is above a certain point (confirm with trial site)
  • You have been diagnosed with mild to moderate depression
  • You are currently having moderate to severe hot flashes
  • You are currently having trouble sleeping because of hot flashes at night
  • You have had a normal mammogram (breast scan) within the last 2 years
  • If you are going through menopause but have not fully completed it and are sexually active, you are willing to use an effective form of birth control throughout the study

Who may not be able to join:

  • You currently have severe depression, or you had severe depression at any point in the last 5 years
  • You have had any thoughts of harming yourself or others
  • You are experiencing symptoms of psychosis (such as hearing or seeing things that are not there)
  • You have a history of any serious mental health condition, such as bipolar disorder, panic disorder, obsessive-compulsive disorder, or an eating disorder like anorexia nervosa
  • You have had a problem with substance misuse, including alcohol, within the last 5 years
  • You have been regularly taking hormone-based medications within the last month
  • You have been regularly taking sleeping pills, antidepressants, or certain over-the-counter products known to affect hot flashes, sleep, or mood within the last 2 weeks
  • You cannot tolerate estrogen therapy or have been advised by a doctor not to use it

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 4: approximately Approved of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 4
Sponsor
Hadine Joffe, MD
Registry
clinicaltrials_gov
Start date
1 August 2003

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov