Overview
Sponsor-declared trial summary
Patients are either or both HPV positive and has cervical cell changes/dysplasia.
The aim is to initiate a blinded study to investigate, if the diagnosis of cervical precancerous lesions can be improved among postmenopausal women aged ≥ 50 years, by providing pretreatment with vaginal estrogen prior to the colposcopic examination. Thereby to reduce the disease burden and prevent cervical cancer.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 1 Sep 2024 → ongoing
- Decision date (initial)
- 2024-08-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Aarhus University
External identifiers
- EU CT number
- 2024-517151-12-00
- EudraCT number
- 2022-000269-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
The aim is to initiate a blinded study to investigate, if the diagnosis of cervical precancerous lesions can be improved among postmenopausal women aged ≥ 50 years, by providing pretreatment with vaginal estrogen prior to the colposcopic examination. Thereby to reduce the disease burden and prevent cervical cancer.
Secondary objectives 1
- This project is important to ensure accuracy and timely diagnosis for women with precancerous cervical lesions. First, this study will address key issues not previously explored about detection of precancerous lesions in order to prevent cervical cancer from developing. Secondly, we believe that the project will contribute with important knowledge that can be incorporated into clinical use, and may help guide future followup guidelines on screening programs. Thirdly, the results can help to avoid repetition of surveys, unnecessary inspections, inappropriate follow-up as well as over- and under treatment. Finally, we believe that evidence obtained from this study will help reduce the number of women with late-stage cervical cancer and poor prognosis.
Conditions and MedDRA coding
Patients are either or both HPV positive and has cervical cell changes/dysplasia.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Women referred for colposcopy aged ≥ 50 years and postmenopausal. • Women referred for colposcopy due to a positive HPV test and/or an abnormal cervical cytology. • Women referred for colposcopy due to previous abnormal cervical histology with minimum 6. months since last colposcopy with biopsies.
Exclusion criteria 1
- Women with use of estrogen within the last 3 months. - Pregnancy - Women with previously amputation, conization or radiation of the cervix
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Between groups, primary outcomes will be: • Scoring of the visibility of the SCJ by the colposcopist as TZ1, TZ2 and TZ3. • Representation of the TZ in at least 25% of the cervical biopsies from each patient described by the pathologist.
Secondary endpoints 1
- Between groups, secondary outcomes will be: • The patients' report on possible side effects during pretreatment. • The proportionen of CIN2+ found in biopsies. • The proportion of diagnostics conization. • Explore for each patient which biopsy represent the most severe histopathologic result by comparing the first biopsy with the other three.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Vagifem 10 mikrogram vaginaltabletter
PRD3094029 · Product
- Active substance
- Estradiol
- Substance synonyms
- OESTRADIOL, OESTRADIOL-17-BETA, 17BETA-ESTRADIOL
- Pharmaceutical form
- VAGINAL TABLET
- Route of administration
- VAGINAL USE
- Max daily dose
- 30 µg microgram(s)
- Max total dose
- 420 µg microgram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- 26990
- MA holder
- NOVO NORDISK A/S
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo til vagifem vaginal tablet 10 mikrogram.
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Pinar Bor
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Pinar Bor
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 8, Code 9 |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 150 | 4 |
| 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 |
|---|---|---|---|---|---|
| Denmark | 2024-09-01 | 2024-09-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol - Extract (for publication) | Protokol vers 5 Track Changes | 5 |
| Protocol (for publication) | Protokol vers 5 | 5 |
| Recruitment arrangements (for publication) | Previously covered | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation vers 6 dec 2025 | 6 |
| Subject information and informed consent form (for publication) | Samtykkeerklring vers 5 | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | Same brochure | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-12 | Denmark | Acceptable 2024-08-26
|
2024-08-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-09 | Acceptable 2024-08-26
|
||
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-16 | Denmark | Acceptable 2025-01-24
|
2025-01-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-21 | Denmark | Acceptable 2025-12-09
|
2025-12-09 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-05 | Denmark | 2026-01-05 |