CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 83 enrolled
Drug / intervention
Fluoxetine +1 moredrug
Likely dose
Fluoxetine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00611975
NCT00611975Phase 4Completed
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Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones

Weill Medical College of Cornell University·interventional·Posted Feb 11, 2008·Updated Dec 10, 2020

In Brief

A Phase 4 clinical trial evaluating Fluoxetine and Bupropion for Healthy. Completed, enrolled 83 participants.

Detailed Summary

This study will evaluate the effect of antidepressants on sex hormone levels in women and if the potential changes in sex hormone levels are related to sexual side effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2008
Enrollment StartOct 1, 2005
Primary CompletionMay 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.4 years ago

Interventions

Fluoxetinedrug

Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.

Bupropiondrug

Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.