Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus

PHASE2RecruitingINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

January 8, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Central Diabetes Insipidus (cDI)
Interventions
DRUG

Intranasal OXT

"Syntocinon® contains the synthesized peptide OXT in a solution formulated to promote absorption through the nasal mucosa. Additional ingredients are E216 (propyl-4-hydroxybenzoate), E218 (methyl-4-hydroxybenzoate), and chlorobutanol hemihydrate. One bottle contains 5 ml, i.e., 200 IU of OXT in total. Each 0.1 ml nasal insulation delivers 4 IU of oxytocin.~OXT (24 IU twice daily) is given for 28 (± 2) days of treatment."

OTHER

Placebo nasal spray

"The placebo will contain no OXT but, otherwise, be identical to the intranasal OXT product with respect to the other ingredients.~Placebo is given twice daily for 28 (± 2) days of treatment."

Trial Locations (2)

3015

NOT_YET_RECRUITING

Erasmus University Medical Center Rotterdam, Rotterdam

4031

RECRUITING

University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism, Basel

All Listed Sponsors
lead

University Hospital, Basel, Switzerland

OTHER