MenorrhagiaPhase 3NCT00360490

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

A Phase 3 study testing Levonorgestrel IUS (Mirena, BAY86-5028) and Medroxyprogesterone acetate in people with Menorrhagia, run by Bayer at 54 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Menorrhagia
What is being tested?: Levonorgestrel IUS (Mirena, BAY86-5028) and Medroxyprogesterone acetate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: 54 sitesin 5 countries
Study dates: Jul 2006to Jun 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

54 sites in 5 countries.

Country

City, postcode or hospital

54 sites in 5 countries

United States37 sites

Study site
Amite, Louisiana, 70422
Study site
Beverly Hills, California, 90211
Study site
Boise, Idaho, 83702
Study site
Boston, Massachusetts, 02118
Study site
Boynton Beach, Florida, 33437
Study site
Burlington, Vermont, 05401
Study site
Carmichael, California, 95608
Study site
Chesterfield, Missouri, 63017
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Chicago, Illinois, 60612
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Clarksville, Tennessee, 37043
Study site
Columbia, South Carolina, 29201
Study site
Houston, Texas, 77030
Study site
Houston, Texas
Study site
Jacksonville, Florida, 32216
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Las Vegas, Nevada
Study site
LasVegas, Nevada, 89106
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Lincoln, Nebraska, 68510
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Littleton, Colorado, 80122
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Marrero, Louisiana, 70072
Study site
Medford, Oregon, 97504
Study site
Moorestown, New Jersey, 08057
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New Brunswick, New Jersey, 08901
Study site
Newburgh, Indiana, 47630
Study site
Norfolk, Virginia, 23507
Study site
Philadelphia, Pennsylvania, 19114
Study site
Pittsburgh, Pennsylvania, 15206
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Portland, Oregon, 97239
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Saginaw, Michigan, 48602
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San Diego, California, 92103
Study site
San Diego, California, 92108
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Santa Monica, California, 90403
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Seattle, Washington, 98105
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South Bend, Indiana, 46601
Study site
Torrance, California, 90509
Study site
Tucson, Arizona, 85712
Study site
West Palm Beach, Florida, 33409
Study site
Winston-Salem, North Carolina, 27103

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Canada10 sites

Study site
Bathurst, New Brunswick, E2A 4X7
Study site
Mirabel, Quebec, J7J 1L2
Study site
Montreal, Quebec, H1T 1P6
Study site
Montreal, Quebec, H2X 1N8
Study site
Ottawa, Ontario, K1H7W9
Study site
Pointe-Claire, Quebec, H9R 4S3
Study site
Québec, Quebec, G1S 2L6
Study site
Regina, Saskatchewan, S4S 0A2
Study site
Shawinigan, Quebec, G9N 2H6
Study site
Toronto, Ontario, M4S 1Y2

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Mexico3 sites

Study site
México, State of Mexico, 16720
Study site
Mexico City, Mexico City, 11000
Study site
Monterrey, Nuevo León, 64460

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Argentina2 sites

Study site
Buenos Aires, Argentina, C1181ACH
Study site
Buenos Aires, Buenos Aires, 1425

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Brazil2 sites

Study site
Campinas, São Paulo, 13083-970
Study site
Curitiba, Paraná, 80030-220

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About this study

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

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

Read the detailed 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.

Conditions: Menorrhagia
Being tested: Levonorgestrel IUS (Mirena, BAY86-5028), Medroxyprogesterone acetate
Keywords: Idiopathic Menorrhagia
Medical subject headings: Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00360490
Study group	Role	What they receive
Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours	Experimental	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. Receives: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Medroxyprogesterone acetate (MPA)	Active comparator	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles. Receives: Drug: Medroxyprogesterone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and up to 6 months
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.
Measured: At 6 months

Secondary outcomes (13)

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.
Measured: Baseline and up to 6 months
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.
Measured: Baseline and up to 3 months
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.
Measured: Baseline and up to 3 months
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
Measured: Baseline and up to 6 months
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.
Measured: Baseline and up to 6 months
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.
Measured: Baseline and up to 6 months
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.
Measured: Baseline and up to 6 months
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.
Measured: Baseline and up to 6 months
Percent Change in Hemoglobin
Measured: Baseline and up to 6 months
Percent Change in Hematocrit
Measured: Baseline and up to 6 months
Percent Change in Serum Ferritin
Measured: Baseline and up to 6 months
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'
Measured: Up to 6 months
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'.
Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Jun 2008

First posted4 Aug 2006 (estimated)
Study startJul 2006
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for MenorrhagiaStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00360490
Sponsor's protocol ID: 91518
Other IDs: 309849
Status last verified: Nov 2013
First submitted: 2 Aug 2006
Last updated: 9 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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: 10.1007/s00404-011-1902-1. Epub 2011 Apr 8.
PubMed 21475963
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.contraception.2012.07.018. Epub 2012 Sep 7.
PubMed 22959906
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):625-632. doi: 10.1097/AOG.0b013e3181ec622b.
PubMed 20733445

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Menorrhagia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00360490
Acronym / sponsor ID: 91518
Conditions: Menorrhagia
Keywords: Idiopathic Menorrhagia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 4 Aug 2006 (estimated)
Results: Posted 19 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Acronyms in the Adverse Event Section:

IUCD Intrauterine Contraceptive Device
MedDRA Medical Dictionary for Regulatory Activities

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours	Experimental	Drug: Levonorgestrel IUS (Mirena, BAY86-5028)Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA)	Active comparator	Drug: Medroxyprogesterone acetateMedroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Levonorgestrel IUS (Mirena, BAY86-5028)Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.	Drug	Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours
Medroxyprogesterone acetateMedroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.	Drug	Medroxyprogesterone acetate (MPA)

Primary outcome

The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
Time frame: Baseline and up to 6 months
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.
Percentage of Patients With Successful Treatment
Time frame: At 6 months
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.

13 secondary outcomes

Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
Time frame: Baseline and up to 6 months
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
Time frame: Baseline and up to 3 months
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
Time frame: Baseline and up to 3 months
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
Time frame: Baseline and up to 6 months
Total Number of Bleeding Days
Time frame: Baseline and up to 6 months
Total Number of Spotting and Bleeding Days
Time frame: Baseline and up to 6 months
Total Number of Spotting Days
Time frame: Baseline and up to 6 months
Total Number of Bleeding Episodes
Time frame: Baseline and up to 6 months
Percent Change in Hemoglobin
Time frame: Baseline and up to 6 months
Percent Change in Hematocrit
Time frame: Baseline and up to 6 months
Percent Change in Serum Ferritin
Time frame: Baseline and up to 6 months
Percentage of Patients With Improvement in the Investigator Global Assessment Scale
Time frame: Up to 6 months
Percentage of Patients With Improvement in the Patients Overall Assessment Scale
Time frame: Up to 6 months

Results and safety

Results posted to the registry on 19 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	82	73
Medroxyprogesterone Acetate (MPA)	83	72

Primary outcome: The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)

Time frame: Baseline and up to 6 months. Median (Full Range). Unit: milliliter (mL)

Measure	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours n = 79	Medroxyprogesterone Acetate (MPA) n = 81
Value	-128.78 (-393.6 to 1242.2)	-17.7 (-271.5 to 78.6)

Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA): p <0.001, Wilcoxon (Mann-Whitney)

Population analysed: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.

Primary outcome: Percentage of Patients With Successful Treatment

Time frame: At 6 months. Number. Unit: Percentage of participants

Measure	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours n = 79	Medroxyprogesterone Acetate (MPA) n = 81
Value	84.8	22.2

Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA): Risk Difference (RD): 62.59 (95% CI 50.56 to 74.61), p <0.001, Chi-squared

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	1 of 82 (1.2%)	67 of 82 (81.7%)	Not reported
Medroxyprogesterone Acetate (MPA)	0 of 83 (0%)	52 of 83 (62.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21475963Endrikat 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: 10.1007/s00404-011-1902-1. Epub 2011 Apr 8.
Results publication: PubMed 22959906Kaunitz 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.contraception.2012.07.018. Epub 2012 Sep 7.
Results publication: PubMed 20733445Kaunitz 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):625-632. doi: 10.1097/AOG.0b013e3181ec622b.

Related trials for Menorrhagia

RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

54 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levonorgestrel IUS (Mirena, BAY86-5028) and Medroxyprogesterone acetate in people with Menorrhagia, run by Bayer at 54 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Canada, Mexico, Argentina, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) (time frame: Baseline and up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00360490, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.