Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

Menorrhagia Clinical Trial

Official title:

A Multicenter, Randomized, Open Label, Parallel Group, Active Control Study to Evaluate the Efficacy and Safety of LNG IUS (Mirena®) as Compared to Medroxyprogesterone Acetate During 6 Cycles of Treatment in Patients With Idiopathic Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360490
• Other study ID #: 91518
• Secondary ID: 309849
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2006
• Last updated: November 14, 2013
• Start date: July 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

Description:

Acronyms in the Adverse Event Section:

• IUCD Intrauterine Contraceptive Device

• MedDRA Medical Dictionary for Regulatory Activities

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.

Other known NCT identifiers

• NCT00360620

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women who have >/= 80 mL blood loss during their menstrual cycles and desire contraception

Exclusion Criteria:

• Post menopausal menstrual cycle < 21 days or > 35 days

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Drug:
• Levonorgestrel IUS (Mirena, BAY86-5028)
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
• Medroxyprogesterone acetate
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Mexico, 

References & Publications (3)

Endrikat J, Vilos G, Muysers C, Fortier M, Solomayer E, Lukkari-Lax E. The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia. Arch Gynecol Obstet. 2012 Jan;285(1):117-21. doi — View Citation

Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, DeSanctis Y, Jensen J. Levonorgestrel-releasing intrauterine system for heavy menstrual bleeding improves hemoglobin and ferritin levels. Contraception. 2012 Nov;86(5):452-7. doi: 10.1016/j.contracepti — View Citation

Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, Muysers C, Jensen JT. Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):625-32. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)	The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.	Baseline and up to 6 months	No
Primary	Percentage of Patients With Successful Treatment	End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.	At 6 months	No
Secondary	Percent Change From Baseline MBL to End of Study MBL (Cycle 6)	The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.	Baseline and up to 6 months	No
Secondary	Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)	The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.	Baseline and up to 3 months	No
Secondary	Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)	The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.	Baseline and up to 3 months	No
Secondary	Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group		Baseline and up to 6 months	No
Secondary	Total Number of Bleeding Days	In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.	Baseline and up to 6 months	No
Secondary	Total Number of Spotting and Bleeding Days	In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.	Baseline and up to 6 months	No
Secondary	Total Number of Spotting Days	In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.	Baseline and up to 6 months	No
Secondary	Total Number of Bleeding Episodes	A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.	Baseline and up to 6 months	No
Secondary	Percent Change in Hemoglobin		Baseline and up to 6 months	No
Secondary	Percent Change in Hematocrit		Baseline and up to 6 months	No
Secondary	Percent Change in Serum Ferritin		Baseline and up to 6 months	No
Secondary	Percentage of Patients With Improvement in the Investigator Global Assessment Scale	"Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'	Up to 6 months	No
Secondary	Percentage of Patients With Improvement in the Patients Overall Assessment Scale	"Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'.	Up to 6 months	No

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