NCT03562624 - A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components | Biotech Hunter

Enrollment

177

Participants

Timeline

Start Date

June 22, 2018

Primary Completion Date

May 16, 2019

Study Completion Date

August 1, 2019

Conditions

Contraception

Interventions

DRUG

BAY98-7443

"Active ingredient content (in mg IND/LNG):~low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5"

DRUG

Levonogestrel (Skyla, BAY86-5028)

Comparative LNG dose

Trial Locations (7)

Dinox GmbH Berlin, Berlin

CRS Clinical Research Services Berlin GmbH, Berlin

CTC North GmbH & Co. KG, Hamburg

Praxis Hr. Dr. K. Peters, Hamburg

Frauenarztpraxis Dr. Wetzel, Blankenburg

Nuvisan GmbH, Neu-Ulm

PAREXEL International Early Phase Clinical Unit (London), Harrow