A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing

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 — INDessa

Contraception Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Contraception

Clinical Trial Details

NCT number	NCT03562624
Study type	Interventional
Source	Bayer
Contact
Status	Completed
Phase	Phase 2
Start date	June 22, 2018
Completion date	August 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02577601` - Impact of Combined Hormonal Contraceptives on UPA	Phase 4
Completed	`NCT03153644` - Improving Contraceptive Care for Women With Medical Conditions
Completed	`NCT04112095` - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use	Phase 3
Recruiting	`NCT05521646` - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative	N/A
Active, not recruiting	`NCT04291001` - Ovarian Function With ENG Implant and UPA Use	Early Phase 1
Completed	`NCT04568980` - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed	`NCT03438682` - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting	`NCT01948882` - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women	N/A
Enrolling by invitation	`NCT04997499` - Adolescent Subcutaneous (SQ) Injection Video Validation	N/A
Recruiting	`NCT03589040` - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant	Phase 2
Completed	`NCT04463680` - Rifampin and the Contraceptive Implant	Phase 4
Completed	`NCT03154125` - Sayana® Press Extension Study	Phase 3
Withdrawn	`NCT03725358` - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.	N/A
Completed	`NCT02957630` - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"	Phase 1/Phase 2
Completed	`NCT02456584` - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods	Phase 1
Completed	`NCT02718222` - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services	N/A
Recruiting	`NCT02121067` - LNG-IUS at 2 Weeks Postpartum	Phase 4
Terminated	`NCT02169869` - Immediate Postplacental IUD Insertion	N/A
Recruiting	`NCT02292056` - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions	N/A
Withdrawn	`NCT01930994` - Kenya Sino-implant (II) PK Study	N/A