Phase 4
N=83
Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00611975 ↗Enrolled (actual)
83
Serious AEs
3.6%
Results posted
Dec 2020
Primary outcome: Primary: Change in 17-OH Pregnenolone — 120; 158; 171; 170 ng/dl — p=>0.8
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluoxetine (Drug); Bupropion (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 17-OH Pregnenolone |
120; 158; 171; 170; 141; 189 | >0.8 |
| SECONDARY Change in Arizona Sexual Experiences Scale (ASEX) |
13.1; 12.9; 11.3; 12.1; 14.0; 12.4 | >0.6 |
| SECONDARY Change in Free Testosterone |
.41; .44; .52; .69; .47; .47 | <.01 sig |
| SECONDARY Change in Estradiol |
42; 38; 131; 134; 107; 109 | >0.4 |
| SECONDARY Change in Prolactin |
11.2; 11.0; 15.9; 14.1; 16.4; 15.4 | >0.7 |
| SECONDARY Change in Progesterone |
0.66; 0.5; 2.4; 2.8; 9.5; 9.6 | >0.9 |
| SECONDARY Change in Dehydroepiandrosterone Sulfate (DHEA-S) |
1.6; 1.8; 1.8; 2.0; 1.6; 1.9 | >0.9 |
| SECONDARY Change in Androstenedione |
0.84; 0.89; 1.13; 1.28; 1.31; 1.14 | >0.1 |
| SECONDARY C-reactive Protein |
— | — |
| SECONDARY Inflammatory Cytokines |
— | — |
| SECONDARY Lymphocyte Activation Markers |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to study entry
- Willing to engage in sexual activity, alone or with a partner, at least weekly for the duration of the study
- Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal ligation, nonhormonal intrauterine device,, partner with vasectomy) for the duration of the study
Exclusion Criteria
- Medical illness that may contribute to sexual dysfunction or affect steroid hormone levels
- Body mass index (BMI) greater than 30
- Elevated testosterone at screening
- History of seizure disorder
- Consumes more than 10 alcoholic beverages per week
Data sourced from ClinicalTrials.gov (NCT00611975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.