The acute effects of testosterone administration in patients with pulmonary hypertension

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003843-28-GB

Enrollment

Registered

2005-02-23

Start date

2005-03-18

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Pulmonary Hypertension

Interventions

Trade Name: Striant Product Name: Striant Pharmaceutical Form: Buccal tablet INN or Proposed INN: Testosterone Other descriptive name: 17 Beta hydroxyandrost-4-en3one Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients over 18 years Pulmonary hypertension diagnosed clinically > 1 month Pulmonary hypertension diagnosed by right heart catheter (pulmonary artery pressure >25mmHg or 30mmHg with exercise) 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Cancer of prostrate or breast, PSA above normal range Unable to lay flat e.g. spinal pathology Mental incompetence Pulmonary hypertension seondary to left sidd heart disease, pulmonary wedge pressure >18 mmHg Pregnancy Current participation in other research projects

Design outcomes

Primary

Measure	Time frame
Main Objective: Does testosterone improve pulmonary artey pressure an pulmonary vascular resistance;Secondary Objective: Does testosterone alter pulmonary capillary wedge pressure, right atrial pressure, right ventricular pressure, right ventricular pressure, cardiac index, mixed venous oxygen saturations, central venous pressure, systemic vascular resistance, pulse oximetry and blood pressure;Primary end point(s): Change in mean pulmonary artery pressure	—

Measure

Time frame

Main Objective: Does testosterone improve pulmonary artey pressure an pulmonary vascular resistance;Secondary Objective: Does testosterone alter pulmonary capillary wedge pressure, right atrial pressure, right ventricular pressure, right ventricular pressure, cardiac index, mixed venous oxygen saturations, central venous pressure, systemic vascular resistance, pulse oximetry and blood pressure;Primary end point(s): Change in mean pulmonary artery pressure

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Countries

United Kingdom

Outcome results

None listed

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