Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Impact of levothyroxine on erectile function measured by the IIEF-15, EHS, PGIC and EDITS questionnaires in patients with hypothyroidism. Prospective, randomized controlled clinical trial with sildenafil 100

This research is investigating treatments for erectile dysfunction (difficulty getting or keeping an erection) in men who have an underactive thyroid gland, a condition called hypothyroidism. The study specifically looks at two different medicines: levothyroxine, which is a common treatment for an underactive thyroid, and sildenafil, a well-known medication for erectile dysfunction. Participants will be divided into groups to receive one of these treatments. Over three months, researchers will use special questionnaires to measure how much their erectile function and general sexual health improve. The main goal is to understand if these treatments, individually or together, can effectively help men dealing with both an underactive thyroid and erectile problems.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Enrolment target

Start

30 Sep 2024

erectile function hypothyroidism subclinic

What is this study about?

This study is designed to help men who experience erectile dysfunction, which means they have trouble getting or keeping an erection firm enough for sexual activity. It's particularly focused on men who also have an underactive thyroid gland, a common condition called hypothyroidism. When your thyroid gland doesn't produce enough hormones, it can affect many parts of your body, and sometimes this includes sexual health.

The researchers want to find out how effective two different medicines are in treating these issues. One medicine is called levothyroxine, which is routinely used to treat an underactive thyroid. The other is sildenafil, a widely recognised treatment specifically for erectile dysfunction. Participants in the study will be given one of these treatments, or possibly a combination, to see which approach works best.

Over a period of three months, the study will carefully track changes in erectile function and overall sexual wellbeing using several detailed questionnaires. By comparing the results from different treatment groups, doctors hope to gain a clearer understanding of how to best help men who are dealing with both an underactive thyroid and erectile problems. This information could lead to better treatment plans in the future.

Key takeaways

This study investigates treatments for erectile dysfunction in men with an underactive thyroid.
It compares levothyroxine (for thyroid) and sildenafil (for erections).
Participation involves taking medication and completing questionnaires for 3 months.
The goal is to find better ways to help men with these linked conditions.
Potential benefits include improved sexual health.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for volunteers who are men and are at least 18 years old. There is no upper age limit, so men of any adult age can take part.

To be eligible, you need to be experiencing erectile dysfunction, which means you have difficulty getting or keeping an erection. You also need to have been diagnosed with hypothyroidism, which is an underactive thyroid gland.

Because this study involves specific medications and conditions, other health factors might be considered when deciding if you can join. It's always best to discuss your full medical history with the study team to confirm if it's right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man?
Are you 18 years old or older?
Do you have a diagnosis of an underactive thyroid (hypothyroidism)?
Are you currently experiencing problems with getting or keeping an erection (erectile dysfunction)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have an initial visit where doctors would confirm you meet all the requirements. You would then be put into one of the study groups, receiving either levothyroxine, sildenafil, or possibly both, for about three months. You would need to take your assigned medication as instructed.

Throughout the three-month treatment period, you would complete a series of questionnaires. These questionnaires will ask about your erectile function and general sexual health at the start and towards the end of the study. There will be at least one follow-up visit or assessment at the end of the three months to see how you responded to the treatment and collect your final questionnaire results. The total duration of your active involvement in the study, including treatment and assessments, would be around three months.

Potential risks and benefits

Potential benefits of joining this study could include receiving a treatment for erectile dysfunction and potentially improving your sexual health and quality of life. The treatments used are already approved and widely prescribed medications. However, like all medicines, levothyroxine and sildenafil can have side effects, which the study team will explain in detail. You might also find that the treatment doesn't work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is hypothyroidism?

Hypothyroidism is a condition where your thyroid gland doesn't produce enough hormones, which can slow down many body functions, including affecting your energy levels and sometimes sexual health.

What is erectile dysfunction?

Erectile dysfunction is when a man has difficulty getting or keeping an erection firm enough for sexual intercourse.

What are levothyroxine and sildenafil?

Levothyroxine is a common medicine used to treat an underactive thyroid. Sildenafil is a well-known medicine used to treat erectile dysfunction.

How long will I be in the study?

Your active participation, including taking medication and completing questionnaires, will last for about three months.

Will I know which treatment I'm getting?

Sometimes in studies like this, participants might not know which specific treatment they are receiving until after the study is over. The study team will explain this to you.