NCT07136922View on ClinicalTrials.gov

First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

October 31, 2026

Study Completion Date

August 31, 2027

Conditions
Luteal Phase InsuffiencyProgesterone Delivery
Interventions
COMBINATION_PRODUCT

400mg progesterone Callavid - 2hr wear

400mg progesterone Callavid, 2 hour wear, twice daily for 7 days

DRUG

Cyclogest 400 mg

Cyclogest 400 mg pessary, twice daily for 7 days

COMBINATION_PRODUCT

400mg progesterone Callavid - 3hr wear

400mg progesterone Callavid, 3 hour wear, twice daily for 7 days

Trial Locations (1)

CV2 2DX

University Hospitals Coventry & Warwickshire NHS Trust, Coventry

All Listed Sponsors
collaborator

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

collaborator

University of Warwick

OTHER

lead

Calla Lily Clinical Care Ltd

INDUSTRY