Clinical trial • Phase III • Endocrinology

Dienogest for Endometriosis | Healthy volunteers

Phase III trial of Dienogest for Endometriosis | Healthy volunteers. 48 participants.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Endometriosis | Healthy volunteers
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-02-2025
First CTIS Authorization Date
18-03-2025

Trial design

Phase III trial across 1 site in Spain.

Target Sample Size
48

Recruitment

Planned Sample Size
48
Recruitment Window Months
6

Geography

Total Number Of Sites
1
Total Number Of Participants
48

Spain

Earliest CTIS Part Ii Submission Date
11-02-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
412
Number Of Sites
1
Number Of Participants
48

Sites

Site Name
Hospital Universitario De La Princesa
Department Name
Clinical Pharmacology
Principal Investigator Name
Francisco Abad Santos
Principal Investigator Email
francisco.abad@salud.madrid.org
Contact Person Name
Francisco Abad Santos
Number Of Participants
48

Sponsor

Primary sponsor

Full Name
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Dienogest
Active Substance
Dienogest
Modality
Small molecule

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