Overview
Sponsor-declared trial summary
Treatment for vaginal atrophy
The aim of this study is to assess the hemostatic balance in postmenopausal women receiving local vaginal estrogen treatment by applying specific assays for coagulation and fibrinolysis.
Key facts
- Sponsor
- Aarhus University Hospital
- 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
- 13 May 2025 → ongoing
- Decision date (initial)
- 2025-03-26
- 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: Pharmacodynamic, Safety
The aim of this study is to assess the hemostatic balance in postmenopausal women receiving local vaginal estrogen treatment by applying specific assays for coagulation and fibrinolysis.
Secondary objectives 1
- The effect of local estrogen treatment on coagulation and contact activation system in postmenopausal women with previous venous thromboembolism (VTE) will also be investigated.
Conditions and MedDRA coding
Treatment for vaginal atrophy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10047782 | Vulvovaginal atrophy | 10038604 |
| 20.0 | LLT | 10063813 | Vaginal petechiae | 10038604 |
| 20.0 | LLT | 10046942 | Vaginal soreness | 10038604 |
| 21.0 | LLT | 10013796 | Dryness vaginal | 10038604 |
| 21.1 | LLT | 10046918 | Vaginal itching | 10038604 |
| 21.1 | LLT | 10011227 | Cough incontinence | 10038359 |
| 21.1 | PT | 10047786 | Vulvovaginal discomfort | 100000004872 |
| 21.1 | LLT | 10046904 | Vaginal dryness | 10038604 |
| 20.0 | LLT | 10005046 | Bladder incontinence | 10038359 |
| 20.0 | LLT | 10048903 | Vaginal irritation | 10038604 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Postmenopausal women aged ≥ 50 without previous VTE, having vulva vaginal atrophy symptoms and indication for standard treatment with vaginal estrogen 10 µg at least three times a week.
- Postmenopausal women aged ≥ 50 with previous VTE, having vulva vaginal atrophy symptoms and indication for standard treatment with vaginal estrogen 10 µg at least three times a week.
Exclusion criteria 5
- Unable to give written informed consent due to language difficulties
- Currently cancer treatment
- Currently in treatment with blood thinning medication (except plateletinhibitor)
- Currently in treatment with local or systematic estrogen
- Systemic inflammatory disease, liver disease or kidney disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Compare changes in thrombin generation and fibrinolysis in postmenopausal women with and without VTE using vaginal estrogen in three months
Secondary endpoints 1
- Compare changes in contact activation system in women receiving vaginal estrogen in three months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP110317214 · ATC
- Active substance
- Nomegestrol Acetate
- Route of administration
- VAGINAL USE
- Max daily dose
- 10 µg microgram(s)
- Max total dose
- 600 µg microgram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Pinar Bor
Public contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Pinar Bor
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 90 | 1 |
| 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 | 2025-05-13 | 2025-05-20 |
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 (for publication) | Protocol | 3 |
| Recruitment arrangements (for publication) | Patient recruitment procedure | 3 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 2 |
| Subject information and informed consent form (for publication) | S3 samtykkeerklring | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Vagifem SmPC | 1 |
| Synopsis of the protocol (for publication) | Synopsis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-18 | Denmark | Acceptable 2025-03-25
|
2025-03-26 |