Ongoing Clinical Trials for Hypopituitarism
There are currently 2 ongoing clinical trials investigating treatments and hormone replacement therapies for hypopituitarism, a condition where the pituitary gland does not produce enough hormones. These studies are examining hydrocortisone formulations for children and the hormone oxytocin’s role in adults with this condition. Both trials are being conducted in Spain.
Clinical trial locations
- Spain
Study on the Tolerability and Acceptance of Oral Hydrocortisone for Children with Adrenal Hyperplasia or Adrenal Insufficiency
This trial focuses on evaluating how well children tolerate and accept two different oral formulations of hydrocortisone. The study is designed for children between 6 and 17 years old who have conditions affecting hormone production, including panhypopituitarism, a form of hypopituitarism.
Who can participate:
- Children aged 6 to 17 years old
- Both boys and girls
- Outpatients who do not need overnight hospital stays
- Children diagnosed with adrenal hyperplasia, isolated primary adrenal insufficiency, or panhypopituitarism
- Children without swallowing difficulties
- Parent or guardian consent is required
Who cannot participate:
- The exclusion criteria focus on specific forms of adrenal conditions
- Patients with secondary or tertiary adrenal insufficiency due to pituitary or hypothalamus problems are excluded
What the trial involves: The study evaluates two different hydrocortisone formulations prepared by hospital pharmacies. Hydrocortisone is a steroid medication that replaces hormones the body cannot produce in sufficient amounts. The main goal is to assess the sensory acceptability of these medications, including how children perceive the taste, texture, and overall experience of taking them. This information will help determine which formulation is more suitable for children, ensuring the treatment is both effective and easy to take.
Investigational drug: Two formulations of hydrocortisone, a corticosteroid that mimics the natural hormone cortisol. The medication is administered orally and helps regulate various bodily functions while reducing inflammation.
The trial began recruiting patients in January 2025 and is expected to end in January 2026.
Study on the Effects of Exenatide in Patients with Hypopituitarism and Oxytocin Deficiency
This trial examines how a medication called Byetta (exenatide) affects hormone production in adults with hypopituitarism. The study specifically focuses on understanding oxytocin secretion patterns and how this hormone impacts various aspects of well-being.
Who can participate:
- Adults aged 18 to 65 years
- Patients with hypopituitarism who have deficiencies in more than one pituitary hormone
- Patients showing at least one sign of hypothalamic damage, such as central diabetes insipidus, severe obesity, excessive eating, MRI evidence of hypothalamic damage, history of traumatic brain injury, or prior radiation treatment for tumors affecting the hypothalamic area
- Patients on stable hormone replacement therapy for at least three months
- Healthy individuals matched by body mass index, age, and sex can also participate as controls
- Women should schedule visits during specific phases of their menstrual cycle to minimize hormonal interference
Who cannot participate:
- Patients outside the specified age range
- Individuals who do not meet gender requirements
- Vulnerable populations requiring special protection
What the trial involves: This randomized, crossover study investigates how exenatide, normally used to control blood sugar in diabetes, affects oxytocin secretion in people with hypopituitarism. Oxytocin is a hormone that plays important roles in social bonding and emotional regulation. Participants will receive both the study medication and a placebo at different times during the study. The medication is administered as a subcutaneous injection. Researchers will monitor oxytocin levels and assess participants’ mood, quality of life, and eating behavior to understand the relationship between hormone levels and well-being.
Investigational focus: The study examines oxytocin, a naturally occurring hormone, to understand whether patients with hypopituitarism have deficiencies and how this might affect their health. By studying oxytocin secretion patterns, researchers hope to learn about potential therapeutic uses for people with hormonal imbalances.
The study is expected to conclude by the end of December 2024.
Summary
Both ongoing clinical trials for hypopituitarism are being conducted in Spain, indicating a concentration of research activity in this country. The two studies address different aspects of hormone replacement and regulation: one focuses on improving treatment options for children by testing hydrocortisone formulations, while the other explores the role of oxytocin in adults with the condition. Notably, the pediatric trial addresses a practical concern about medication acceptability in children, which is crucial for treatment adherence. The adult trial takes an innovative approach by investigating whether exenatide, a diabetes medication, can influence hormone patterns in hypopituitarism patients. Together, these studies represent efforts to improve both the delivery and understanding of hormone therapies for people living with this condition.
