Phase 4
Completed N=83
Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
Healthy
Source: ClinicalTrials.gov NCT00611975 ↗
Enrolled (actual)
83
Serious AEs
3.6%
Results posted
Dec 2020
Primary outcomePrimary: Change in 17-OH Pregnenolone — 120; 158; 171; 170 ng/dl — p=>0.8
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
— | — |
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. Informational only — not medical advice.