Plasma Oxytocin in Response to Oral Estradiol Valerate and Ethinylestradiol in Healthy Controls and Patients With AVP-Deficiency

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The PHOENIX study aims to investigate whether oral estradiol valerate (EV) and ethinylestradiol (EE) can stimulate oxytocin (OXT) and neurophysin-1 (NP-1) release in humans. The goal is to assess their potential as a safe diagnostic stimulation test for oxytocin deficiency, particularly in patients with arginine vasopressin (AVP) deficiency.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

⁃ Part 1

• Adult healthy controls

• No medication (including hormonal contraception)

• Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months

⁃ Part 2

• Confirmed diagnosis of AVP-Deficiency

• Age ≥ 18 years

• Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months or in the case of hormone replacement therapy, with a 1-week pause from the respective treatment

Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Andi Nikaj, MD
andi.nikaj@usb.ch
+41 61 328 57 43
Backup
Ursula Gobrecht-Keller, MD
ursula.gobrecht@usb.ch
+41 61 32 86028
Time Frame
Start Date: 2026-01-09
Estimated Completion Date: 2027-02
Participants
Target number of participants: 28
Treatments
Experimental: estradiol valerate
Experimental: esthinylestradiol
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov