Comparison of vascular findings between symptomatic and asymptomatic postmenopausal women before and during hormone therapy: randomized, placebo-controlled prospective study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005091-16-FI

Enrollment

160

Registered

2005-01-24

Start date

2005-03-08

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy postmenopausal women willing to initiate hormone therapy.

Interventions

Trade Name: Divina Product Name: Divina Pharmaceutical Form: Tablet INN or Proposed INN: estradiolvalerate Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 2-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy postmenopausal women between ages 48-55 (minimum of 6 months and maximum of 36 months from last menstrual period) that are willing to start HT for the treatment of vasomotor symptoms, other climacteric symptoms such as vaginal atrophy or prevention of osteoporosis. FSH over 30 U/L. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Dyslipidemia, diabetes or overt hypertension (blood pressure > 140/90) are excluding criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: In a randomized clinical trial compare recently menopausal women with or without vasomotor symptoms on response to HT as measured by several different biological markers;Secondary Objective: ;Primary end point(s): Pulse Wave analysis	—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026