Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
120
Countries
1
Sites
2
Cervical cancer
To assess the improvement in sexual function and self-perceived quality of life using PROMs (Patient-Reported Outcomes) in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle compared to those who undergo care within routine clinical practice.
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 8 May 2026 → ongoing
- Decision date (initial)
- 2025-05-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Public TV Marathon
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To assess the improvement in sexual function and self-perceived quality of life using PROMs (Patient-Reported Outcomes) in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle compared to those who undergo care within routine clinical practice.
Secondary objectives 5
- To assess sexual function (using the FSFI questionnaire) in women treated for cervical cancer after completion of treatment and its evolution over one year.
- To assess self-perceived quality of life (using the EORTC QLQ-30, Cx- 24 and Cervantes-Reduced Scale) questionnaires in women treated for cervical cancer after completing treatment and its evolution over one year.
- To detect the needs of the treated patients based on the PROMs that allow proposing improvement strategies that can increase their sexual health and quality of life.
- To assess vaginal trophism more objectively using the Vaginal Health Index (VHI) and vaginal thickness measured by ultrasound in women with cervical cancer after completion of treatment and over the course of one year.
- To assess adherence to the proposed multimodal treatment and the adverse effects reported.
Conditions and MedDRA coding
Cervical cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Description of allocation and arms All patients will be randomized in two arms
|
Randomised Controlled | None | Control Arm: Standard of care Intervention arm: Patients will receive a multimodal intervention in the sexual sphere |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Women of legal age
- Patients with primary cervical cancer stage FIGO I-III (initial or locally advanced) of squamous histology, adenocarcinoma or adenosquamous.
- Patients treated for cancer with surgery and/or radiotherapy ± systemic treatment in the Gynaecological Oncology Units of hospitals in Spain.
- Complete response after oncospecific treatment was obtained.
- Signature of the informed consent (IC) by the patient or responsible family member.
Exclusion criteria 9
- Patients under 18 years of age
- Pregnancy or breastfeeding.
- Partial response after completion of oncospecific treatment.
- Patients with premalignant pathology.
- Diagnosis of a tumor of non-cervical origin or atypical histologies.
- Impossibility of completing the questionnaires included in the protocol autonomously.
- Contraindications to the use of vaginal estrogens.
- Patients undergoing fertility-sparing treatment (trachelectomy or conization).
- Patients undergoing palliative treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Global score on the FSFI (Female Sexual Function Index) form at the end of the first year after treatment.
Secondary endpoints 5
- Score on the FSFI form at diagnosis, after treatment (defined as baseline level: 1 month after surgery and 3 months after treatment with radiotherapy ± systemic treatment), at 6 and 12 months after treatment. The score in each of the sexual response domains that make up the FSFI (subjective desire and stimulus, lubrication, orgasm, satisfaction, and pain or discomfort) will also be evaluated individually.
- Score on the quality of life forms (EORTC QLQ-30, Cx-24, Cervantes- Reduced) at diagnosis, after treatment (baseline level), at 6 months and 12 months after treatment. The score on each of the 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), the global health status scale and the 6 independent items of EORTC QLQ-30
- Adherence to multimodal treatment in the intervention arm, defined as the percentage of patients in the intervention arm who have undergone each of the items included in the multimodal treatment.
- Adverse effects with the use of treatments, assessing their number, severity and type (A - Augmented; B - Bizarre)
- Vaginal Health Index (VHI) score and thickness measured by ultrasound, for assessment of vaginal trophism at diagnosis, after treatment (baseline level), at 6 and 12 months after treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
SCP150153 · ATC
- Active substance
- Estriol
- Route of administration
- VAGINAL USE
- Max daily dose
- 100 µg microgram(s)
- Max total dose
- 100 µg microgram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03CA04 — ESTRIOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10087MIG · Substance
- Active substance
- Promestriene
- Pharmaceutical form
- VAGINAL CREAM
- Route of administration
- VAGINAL USE
- Max daily dose
- 30 mg/g milligram(s)/gram
- Max total dose
- 30 mg/g milligram(s)/gram
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10076MIG · Substance
- Active substance
- Progesterone
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07245MIG · Substance
- Active substance
- Estradiol Valerate
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11941MIG · Substance
- Active substance
- Estradiol Hemihydrate
- Pharmaceutical form
- TRANSDERMAL PATCH
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 100 µg microgram(s)
- Max total dose
- 2100 µg microgram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Laura Burunat Ruesgas
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Laura Burunat Ruesgas
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 120 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-05-08 | 2026-05-08 |
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 annexed_2025-521460-36-00_redacted | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Providence_ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF with Appendix 1_SP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC__Blissel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Evopad | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Progesterona | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Progynova | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Promestireno | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis_EN-2025-521460-36-00_redacted | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis_SP-2025-521460-36-00_redacted | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-14 | Spain | Acceptable 2025-05-09
|
2025-05-09 |