Low-dose vaginal estrogen for postmenopausal vaginal atrophy and blood clotting
Is There an Effect of Local Vaginal Estrogen Treatment on the Hemostatic Parameters in Postmenopausal Women?
This study will test whether using low-dose vaginal estrogen tablets for three months changes blood clotting markers in postmenopausal women with vaginal atrophy, including those with and without prior blood clots.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT07160504 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study enrolls 90 postmenopausal women aged 50 or older with symptomatic vaginal atrophy who are prescribed low-dose vaginal estradiol tablets (10 µg) at least three times per week. Participants are split into two equal groups of 45 based on whether they have a prior history of venous thromboembolism. Blood samples are taken at baseline before starting treatment and again after three months to measure a panel of hemostatic parameters and compare changes over time. Women with current systemic estrogen use, active cancer treatment, systemic inflammatory, liver or kidney disease, or on systemic anticoagulants are excluded to avoid confounding factors.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 50 or older with symptomatic vaginal atrophy who can use 10 µg vaginal estradiol tablets, are not on systemic estrogen or anticoagulant therapy, and can attend study visits in Danish.
Not a fit: Patients currently receiving systemic estrogen, active cancer therapy, systemic anticoagulants, or those with systemic inflammatory, liver, or kidney disease are unlikely to benefit or be eligible for this study.
Why it matters
Potential benefit: If results show no meaningful change in clotting markers, this could reassure patients and clinicians that short-term low-dose vaginal estrogen is unlikely to increase clotting risk.
How similar studies have performed: Previous studies generally indicate that low-dose local vaginal estrogen has minimal systemic absorption and little effect on hemostatic markers, but evidence is limited for women with a history of venous thromboembolism.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal women aged ≥ 50 * Symptomatic vaginal atrophy * Indication for standard treatment with vaginal estrogen tablets 10 µg at least three times a week * Study population 1: without a history of venous thromboembolic event * Study population 2: with a history of venous thromboembolic event Exclusion Criteria: * Unable to give written informed consent * Does not speak Danish * Current cancer treatment * Current treatment with blood thinning medication (except plateletinhibitor) * Current treatment with local or systematic estrogen * Systemic inflammatory disease, liver disease or kidney disease
Where this trial is running
Aarhus N
- Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Pinar Bor, Pinar Bor, MD, PhD, Prof.
- Email: isipinbo@rm.dk
- Phone: +45 78 42 11 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.