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IMPACT OF LEVOTHYROXINE ON ERECTILE FUNCTION IN PATIENTS WITH HYPOTHYROIDISM
EU CTIS ID: 2024-514789-38-00
What this study is testing
To assess the impact on sexual activity of levothyroxine treatment (adjusted for weight (kg) and baseline TSH values) in patients with subclinical hypothyroidism (TSH >5) and erectile dysfunction as measured by the International Index of Erectile Function (IIEF-5), Erectile hardness score (EHS), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and Patient Global Impression of Change (PGIC) questionnaires
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Heterosexual males over 18 years of age
- Sexually active males
- Males diagnosed with HTs (TSH >5 with normal T4)
- Males with a diagnosis of ED according to the IIEF-15 questionnaire (score <25 points)
- Ability to complete the IIEF-15, EHS, PGIC and EDITS questionnaires
- Signature of informed consent
You likely can't join if
- Presence of penile pathology that may explain the ED such as Peyronie's disease or hypospadias
- Presence of endocrinological pathology that can explain the ED (analytical alteration of FSH, LH, progesterone, estradiol and/or testosterone hormones)
- Patients with diagnosed neurological disease (Parkinson's, multiple sclerosis, spinal cord trauma, etc)
- Patients operated on pelvic organs with possible neurological involvement (radical prostatectomy, abdomino-perineal amputation, etc.)
- Patients with pelvic radiotherapy (external or brachytherapy)
- Patients under active treatment for ED (phosphodiesterase 5 inhibitors, intraurethral or intracavernous alprostadil or with penile prosthesis placement)
See the full eligibility criteria
- Heterosexual males over 18 years of age
- Sexually active males
- Males diagnosed with HTs (TSH >5 with normal T4)
- Males with a diagnosis of ED according to the IIEF-15 questionnaire (score <25 points)
- Ability to complete the IIEF-15, EHS, PGIC and EDITS questionnaires
- Signature of informed consent
- Presence of penile pathology that may explain the ED such as Peyronie's disease or hypospadias
- Presence of endocrinological pathology that can explain the ED (analytical alteration of FSH, LH, progesterone, estradiol and/or testosterone hormones)
- Patients with diagnosed neurological disease (Parkinson's, multiple sclerosis, spinal cord trauma, etc)
- Patients operated on pelvic organs with possible neurological involvement (radical prostatectomy, abdomino-perineal amputation, etc.)
- Patients with pelvic radiotherapy (external or brachytherapy)
- Patients under active treatment for ED (phosphodiesterase 5 inhibitors, intraurethral or intracavernous alprostadil or with penile prosthesis placement)
- Patients with low sexual activity (<1 sexual encounter/15 days)
- Patient unable to complete the questionnaires
- Contraindication for taking treatment with levothyroxine or sildenafil
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.