Overview
Sponsor-declared trial summary
erectile function
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 In…
Key facts
- Sponsor
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- completed 1 Dec 2025
- Decision date (initial)
- 2024-09-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
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
Conditions and MedDRA coding
erectile function
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | 457531 Impact of levothyroxine on erectile function measured by IIEF-15, EHS, PGIC and EDITS questionnaires in patients with hypothyroidism. Prospective, randomized, controlled clinical trial with sildenafil 100
|
Randomised Controlled | None | Grupo A: Sildenafilo 100 mg Grupo B: Levotiroxina ajustado a peso (kg) y niveles basales de TSH Grupo C: Sildenafilo 100 mg + Levotiroxina ajustado a peso (kg) y niveles basales de TSH |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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
Exclusion criteria 9
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The evolution of the scores measured by the IIEF-15, EHS, PGIC and EDITS questionnaires throughout the baseline measurements, and at the 3-month post-treatment follow-up in the three study groups after the start of treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP1119298 · ATC
- Active substance
- Sildenafil Citrate
- Substance synonyms
- Sildenafil dihydrogen citrate
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- G04BE03 — SILDENAFIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP108721542 · ATC
- Active substance
- Levothyroxine
- Substance synonyms
- L-THYROXINE
- Route of administration
- ORAL USE
- Max daily dose
- 200 µg microgram(s)
- Max total dose
- 18000 µg microgram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- H03AA01 — LEVOTHYROXINE SODIUM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Sponsor organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Address
- Cruces Plaza 12
- City
- Barakaldo
- Postcode
- 48903
- Country
- Spain
Scientific contact point
- Organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Contact name
- REGULATORIA
Public contact point
- Organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Contact name
- REGULATORIA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 90 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOL_C_V8_20241018 | 8 |
| Protocol (for publication) | D1_PROTOCOL_C_V8_20241018_cc | 8 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Cuestionario POST IIEF15 EHS PGIC EDITS_2024-514789-38-00 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Cuestionario PRE IIEF15 EHS_2024-514789-38-00 | 1 |
| Subject information and informed consent form (for publication) | HGU_HIP-CI V5_20241018 | 5 |
| Subject information and informed consent form (for publication) | HGU_HIP-CI V5_20241018_CC | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Levotiroxina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Sildenafilo | 1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOL SYNOPSIS_C_V2_20240711 | 2 |
| Synopsis of the protocol (for publication) | D1_PROTOCOL SYNOPSIS_E_V2_20240711 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-27 | Spain | Acceptable with conditions 2024-09-30
|
2024-09-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-21 | Spain | Acceptable 2024-12-23
|
2024-12-23 |