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

Multi-center, Randomized, Comparator-controlled, Single-blind, Parallel-Group Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of an Intrauterine System (BAY987443) With Three Different Release Rates of Indomethacin and One Release Rate of Levonorgestrel, as Compared With Jaydess, in a Combined Proof-of-concept and Dose Finding Study in Healthy Pre-menopausal Women Treated for 90 Days

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is the first study investigating the combined intrauterine administration of LNG (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose finding (DF) study in pre-menopausal women. It is designed to investigate the pharmacodynamics (PD) of BAY 987443 (i.e. IUS (intrauterine system) releasing LNG and IND), as well as pharmacokinetics (PK) of both active substances, safety and tolerability. In this study, Jaydess, as an LNG-only IUS, will be used as a comparator.

Conditions

• Contraception

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-22
• Primary completion: 2019-05-16
• Completion: 2019-08-01
• First posted: 2018-06-19
• Last updated: 2019-08-12

Locations

7 sites across 2 countries: Germany, United Kingdom