Phase 4
Completed N=22
Testosterone Patch's Effects on the Cardiovascular System and Libido
Source: ClinicalTrials.gov NCT01208038 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Arterial Compliance - Augmentation Index — 1.067 percentage of Arterial stiffness
Summary
The purpose of this study is to examine the effect of the testosterone patch, in addition to hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arterial Compliance - Augmentation Index |
1.067 | — |
| PRIMARY Endothelial Function |
0.06 | — |
| SECONDARY Insulin Resistance - HOMA-IR |
0.106 | — |
| SECONDARY Libido - B-PFSF Score |
5.05 | — |
Eligibility Criteria
Inclusion Criteria
- healthy postmenopausal women
- 45 to 70 years of age
- on HRT and willing to continue the same HRT regimen for the next 6 months
- are in a stable relationship which was started at least 6 months ago
- continue on any concomitant medications without any change during the study
- give informed consent.
Exclusion Criteria
- have dyspareunia
- have received testosterone implants within the last 12 months or other androgen therapy within the last 6 months
- have received any medications which may interfere with the study (SSRI, anti-androgens, PDE5 inhibitors, DHEA, SERMS)
- have a significant psychiatric disorder
- have a history of breast cancer
- have diabetes, thromboembolic disorders, cardiovascular disease, any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia
- are on tibolone (due to its androgenic effect).
Data sourced from ClinicalTrials.gov (NCT01208038). 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.