Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

Phase 3 Completed 394 enrolled Bayer

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.

Timeline

Start: 2000-05
Primary completion: 2008-05
Completion: 2008-05

Publications

Results Depypere HT, Hillard T, Erkkola R, Lukkari-Lax E, Kunz M, Rautiainen P, Schram JH. A 60-month non-comparative study on bleeding profiles with the levonorgestrel intrauterine system from the late transition period to estrogen supplemented menopause. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):176-80. doi: 10.1016/j.ejogrb.2010.08.017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	20 ug	Other

Indications

No indication recorded.