Clinical trial • Not applicable • Other
NOMEGESTROL ACETATE | ESTRADIOL HEMIHYDRATE for Vulvovaginal atrophy | Vaginal atrophy
Not applicable trial of NOMEGESTROL ACETATE | ESTRADIOL HEMIHYDRATE for Vulvovaginal atrophy | Vaginal atrophy.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Vulvovaginal atrophy | Vaginal atrophy
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-12-2024
- First CTIS Authorization Date
- 26-03-2025
Trial design
Two groups: postmenopausal women without previous VTE and postmenopausal women with previous VTE; all receive standard vaginal estrogen 10 µg (at least three times a week). No drug-placebo comparator specified.-controlled Not applicable trial across 1 site in Denmark.
- Comparator
- Two groups: postmenopausal women without previous VTE and postmenopausal women with previous VTE; all receive standard vaginal estrogen 10 µg (at least three times a week). No drug-placebo comparator specified.
- Target Sample Size
- 90
- Trial Duration For Participant
- 90
Eligibility
Recruits 90 Vulnerable population not selected (isVulnerablePopulationSelected: false). Written informed consent is required; participants unable to give written informed consent due to language difficulties are excluded ("Unable to give written informed consent due to language difficulties"). No assent procedures described (study population limited to postmenopausal adult women)..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected: false). Written informed consent is required; participants unable to give written informed consent due to language difficulties are excluded ("Unable to give written informed consent due to language difficulties"). No assent procedures described (study population limited to postmenopausal adult women).
Inclusion criteria
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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
- {"criterion_text":"- Unable to give written informed consent due to language difficulties"}
- {"criterion_text":"- Currently cancer treatment"}
- {"criterion_text":"- Currently in treatment with blood thinning medication (except plateletinhibitor)"}
- {"criterion_text":"- Currently in treatment with local or systematic estrogen"}
- {"criterion_text":"- Systemic inflammatory disease, liver disease or kidney disease"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Compare changes in thrombin generation and fibrinolysis in postmenopausal women with and without VTE using vaginal estrogen in three months","definition_or_measurement_approach":"Assessment of hemostatic balance by applying specific assays for coagulation and fibrinolysis (thrombin generation and fibrinolysis assays) over three months; measured changes compared between women with and without prior VTE."}
Secondary endpoints
- {"endpoint_text":"- Compare changes in contact activation system in women receiving vaginal estrogen in three months","definition_or_measurement_approach":"Assessment of contact activation system parameters using specific laboratory assays over three months in women receiving vaginal estrogen."}
Recruitment
- Planned Sample Size
- 90
- Recruitment Window Months
- 24
- Consent Approach
- Written informed consent required from participants (subject information and informed consent form documents present). Participants who are unable to give written informed consent due to language difficulties are excluded. No assent process described (adult postmenopausal population). Languages of consent forms not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 90
Denmark
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 26-03-2025
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 90
Sites
- Site Name
- Aarhus University Hospital
- Department Name
- Gynecology
- Principal Investigator Name
- Isil Bor
- Principal Investigator Email
- isibor@rm.dk
- Contact Person Name
- Isil Bor
- Contact Person Email
- isibor@rm.dk
- Number Of Participants
- 90
Sponsor
Primary sponsor
- Full Name
- Aarhus University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code '1' (role not further detailed); contact gcp@clin.au.dk","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- ESTRADIOL
- Active Substance
- NOMEGESTROL ACETATE | ESTRADIOL HEMIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- Vaginal use
- Route
- Vaginal
- Authorisation Status
- Used in routine clinical practice (SmPC provided; product entries show prodAuthStatus: 2 and marketingAuthNumber: '-')
- Starting Dose
- 10 µg
- Dose Levels
- 10 µg (standard dose specified)
- Frequency
- At least three times a week
- Maximum Dose
- Max daily dose 10 µg; max total amount 600 µg
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