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CompletedNCT00360490Updated Dec 9, 2013Results posted

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 interventional study of Levonorgestrel IUS (Mirena, BAY86-5028) and Medroxyprogesterone acetate in Menorrhagia, sponsored by Bayer. Completed at 54 sites in 5 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-09.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Menorrhagia

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Keywords

  • Idiopathic Menorrhagia
03

In context

Menorrhagia

182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.

This study's enrollment of 165 is above the median of 100 across 133 interventional studies indexed under Menorrhagia.

Browse Menorrhagia studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Post menopausal menstrual cycle \< 21 days or > 35 days
  • Pregnancy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours

    Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.

    Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

  • Active comparator
    Medroxyprogesterone acetate (MPA)

    Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

    Drug: Medroxyprogesterone acetate

Interventions

  • DrugLevonorgestrel IUS (Mirena, BAY86-5028)

    Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.

  • DrugMedroxyprogesterone acetate

    Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and up to 6 months

  2. 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.

    Time frame: At 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline and up to 6 months

  2. 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.

    Time frame: Baseline and up to 3 months

  3. Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)

    The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.

    Time frame: Baseline and up to 3 months

  4. Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group

    Time frame: Baseline and up to 6 months

  5. 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.

    Time frame: Baseline and up to 6 months

  6. 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.

    Time frame: Baseline and up to 6 months

  7. 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.

    Time frame: Baseline and up to 6 months

  8. 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.

    Time frame: Baseline and up to 6 months

  9. Percent Change in Hemoglobin

    Time frame: Baseline and up to 6 months

  10. Percent Change in Hematocrit

    Time frame: Baseline and up to 6 months

  11. Percent Change in Serum Ferritin

    Time frame: Baseline and up to 6 months

  12. 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'

    Time frame: Up to 6 months

  13. 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'.

    Time frame: Up to 6 months

07

Results

Posted Nov 19, 2009

Participant flow

Participant flow — Overall Study
MilestoneLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Started8283
Completed7372
Not completed911
Withdrew: Adverse event42
Withdrew: Lost to follow-up21
Withdrew: Physician decision21
Withdrew: Protocol violation04
Withdrew: Withdrawal by subject13

Outcome measures

PrimaryThe 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.

Time frame:
Baseline and up to 6 months
Reported as:
Median · milliliter (mL)
The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
milliliter (mL)Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)-128.78 (-393.6 to 1242.2)-17.7 (-271.5 to 78.6)
Statistical analysis
  • Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA) · Wilcoxon (Mann-Whitney) · p = <0.001
PrimaryPercentage 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.

Time frame:
At 6 months
Reported as:
Number · Percentage of participants
Percentage of Patients With Successful Treatment
Percentage of participantsLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Percentage of Patients With Successful Treatment84.822.2
Statistical analysis
  • Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA) · Chi-squared · p = <0.001 · Risk difference (rd): 62.59 · 95% CI 50.56 to 74.61
SecondaryPercent Change From Baseline MBL to End of Study MBL (Cycle 6)

The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.

Time frame:
Baseline and up to 6 months
Reported as:
Mean · Percent change
Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
Percent changeLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Percent Change From Baseline MBL to End of Study MBL (Cycle 6)-70.75 ± 88.31-21.54 ± 35.79
Statistical analysis
  • Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA) · t-test, 2 sided · p = <0.001 · Mean difference (final values): -49.2 · 95% CI -70.2 to -28.3
SecondaryAbsolute 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.

Time frame:
Baseline and up to 3 months
Reported as:
Median · milliliter (mL)
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
milliliter (mL)Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)-115.13 (-405.8 to 54.4)-3.15 (-270.9 to 146.7)
Statistical analysis
  • Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA) · Wilcoxon (Mann-Whitney) · p = <0.001
SecondaryPercent Change From Baseline MBL to Mid-study MBL (Cycle 3)

The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.

Time frame:
Baseline and up to 3 months
Reported as:
Mean · Percent change
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
Percent changeLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)-61.71 ± 41.76-11.11 ± 42.46
Statistical analysis
  • Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA) · t-test, 2 sided · p = <0.001 · Mean difference (final values): -50.6 · 95% CI -63.8 to -37.4
SecondaryPercentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
Time frame:
Baseline and up to 6 months
Reported as:
Number · percentage of participants
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
percentage of participantsLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
0 days97.53
30 days95.06
60 days93.83
90 days92.59
120 days91.36
150 days90.12
180 days90.12
SecondaryTotal 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.

Time frame:
Baseline and up to 6 months
Reported as:
Mean · days
Total Number of Bleeding Days
daysLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Baseline5.64 ± 1.5735.64 ± 1.280
Cycle 110.23 ± 5.7845.17 ± 1.349
Cycle 27.88 ± 5.2565.15 ± 1.459
Cycle 35.92 ± 4.5055.25 ± 1.648
Cycle 44.77 ± 4.4554.82 ± 1.591
Cycle 53.77 ± 4.5604.89 ± 1.325
Cycle 64.16 ± 4.6315.29 ± 1.835
SecondaryTotal 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.

Time frame:
Baseline and up to 6 months
Reported as:
Mean · days
Total Number of Spotting and Bleeding Days
daysLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Baseline6.30 ± 1.7446.80 ± 1.990
Cycle 119.70 ± 7.8946.65 ± 2.265
Cycle 217.46 ± 7.2937.46 ± 2.294
Cycle 311.89 ± 7.4156.92 ± 2.569
Cycle 410.42 ± 6.4266.66 ± 2.372
Cycle 510.25 ± 7.3596.89 ± 2.482
Cycle 68.58 ± 7.0246.90 ± 2.834
SecondaryTotal 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.

Time frame:
Baseline and up to 6 months
Reported as:
Mean · days
Total Number of Spotting Days
daysLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Baseline1.23 ± 1.1911.84 ± 1.638
Cycle 19.47 ± 6.9331.48 ± 1.613
Cycle 29.58 ± 7.0732.31 ± 2.004
Cycle 37.27 ± 6.4212.27 ± 2.150
Cycle 45.65 ± 5.0791.84 ± 1.767
Cycle 56.48 ± 5.8692.00 ± 2.297
Cycle 65.38 ± 6.3302.23 ± 2.532
SecondaryTotal 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.

Time frame:
Baseline and up to 6 months
Reported as:
Mean · number of bleeding episodes
Total Number of Bleeding Episodes
number of bleeding episodesLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Baseline1.01 ± 0.0751.03 ± 0.115
Cycle 11.75 ± 0.7070.98 ± 0.222
Cycle 20.88 ± 0.6531.01 ± 0.194
Cycle 30.99 ± 0.6470.97 ± 0.228
Cycle 40.76 ± 0.6150.99 ± 0.202
Cycle 50.77 ± 0.7551.01 ± 0.208
Cycle 60.70 ± 0.7391.04 ± 0.359
SecondaryPercent Change in Hemoglobin
Time frame:
Baseline and up to 6 months
Reported as:
Median · percent change
Percent Change in Hemoglobin
percent changeLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Baseline to cycle 33.82 (-7.1 to 25.3)1.65 (-15.4 to 20.2)
Cycle 3 to cycle 63.28 (-7.9 to 18.0)0.83 (-11.0 to 16.9)
Baseline to cycle 67.50 (-3.6 to 44.0)1.87 (-17.9 to 33.3)
SecondaryPercent Change in Hematocrit
Time frame:
Baseline and up to 6 months
Reported as:
Median · percent change
Percent Change in Hematocrit
percent changeLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Baseline to cycle 34.9 (-8 to 21)0.0 (-15 to 21)
Cycle 3 to cycle 62.4 (-11 to 13)0.0 (-14 to 18)
Baseline to cycle 65.4 (-7 to 26)0.0 (-21 to 26)
SecondaryPercent Change in Serum Ferritin
Time frame:
Baseline and up to 6 months
Reported as:
Median · percent change
Percent Change in Serum Ferritin
percent changeLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Baseline to cycle 313.8 (-67 to 300)0.0 (-78 to 380)
Cycle 3 to cycle 648.3 (-51 to 293)16.7 (-78 to 560)
Baseline to cycle 668.8 (-52 to 1440)14.3 (-87 to 540)
SecondaryPercentage 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'

Time frame:
Up to 6 months
Reported as:
Number · percentage
Percentage of Patients With Improvement in the Investigator Global Assessment Scale
percentageLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Cycle 394.771.2
Cycle 693.661.0
SecondaryPercentage 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'.

Time frame:
Up to 6 months
Reported as:
Number · percentage
Percentage of Patients With Improvement in the Patients Overall Assessment Scale
percentageLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
Cycle 393.374.0
Cycle 693.667.1
Statistical analysis
  • Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA) · Risk difference (rd): 26.06 · 95% CI 14.75 to 37.36

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours—1/82 (1.2%)67/82 (81.7%)
Medroxyprogesterone Acetate (MPA)—0/83 (0%)52/83 (62.7%)
Most frequent serious events
Most frequent serious events
EventLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
EndometriosisReproductive system and breast disorders1/820/83
Most frequent other events
Showing 10 of 38
Most frequent other events
EventLevonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)
HeadacheNervous system disorders13/829/83
Ovarian cystReproductive system and breast disorders10/822/83
Vaginitis bacterialInfections and infestations9/823/83
Urinary tract infectionInfections and infestations6/823/83
Weight increasedInvestigations5/826/83
SinusitisInfections and infestations5/824/83
Upper respiratory tract infectionInfections and infestations5/821/83
AcneSkin and subcutaneous tissue disorders5/825/83
HypertensionVascular disorders5/821/83
Abdominal pain lowerGastrointestinal disorders3/825/83

Baseline characteristics

Age Continuous
Age Continuous(years)Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)Total
Mean38.3 (26 to 50)39.3 (26 to 53)38.8 (26 to 53)
Sex: Female, Male
Sex: Female, Male(Participants)Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)Total
Female8283165
Male000
Body mass index
Body mass index(kg/m²)Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 HoursMedroxyprogesterone Acetate (MPA)Total
Mean27.19 ± 3.90327.36 ± 4.61027.28 ± 4.263
08

Study locations

54 sites
  • Tucson, Arizona 85712, United States
  • Beverly Hills, California 90211, United States
  • Carmichael, California 95608, United States
  • San Diego, California 92103, United States
  • San Diego, California 92108, United States
  • Santa Monica, California 90403, United States
  • Torrance, California 90509, United States
  • Littleton, Colorado 80122, United States
  • Boynton Beach, Florida 33437, United States
  • Jacksonville, Florida 32216, United States
  • West Palm Beach, Florida 33409, United States
  • Boise, Idaho 83702, United States
  • Chicago, Illinois 60612, United States
  • Newburgh, Indiana 47630, United States
  • South Bend, Indiana 46601, United States
  • Amite, Louisiana 70422, United States
  • Marrero, Louisiana 70072, United States
  • Boston, Massachusetts 02118, United States
  • Saginaw, Michigan 48602, United States
  • Chesterfield, Missouri 63017, United States
  • Lincoln, Nebraska 68510, United States
  • Las Vegas, Nevada, United States
  • LasVegas, Nevada 89106, United States
  • Moorestown, New Jersey 08057, United States
  • New Brunswick, New Jersey 08901, United States
  • Winston-Salem, North Carolina 27103, United States
  • Medford, Oregon 97504, United States
  • Portland, Oregon 97239, United States
  • Philadelphia, Pennsylvania 19114, United States
  • Pittsburgh, Pennsylvania 15206, United States
  • Columbia, South Carolina 29201, United States
  • Clarksville, Tennessee 37043, United States
  • Houston, Texas 77030, United States
  • Houston, Texas, United States
  • Burlington, Vermont 05401, United States
  • Norfolk, Virginia 23507, United States
  • Seattle, Washington 98105, United States
  • Buenos Aires, 1425, Argentina
  • Buenos Aires, C1181ACH, Argentina
  • Curitiba, Parana 80030-220, Brazil
  • Campinas, Sao Paulo 13083-970, Brazil
  • Bathurst, New Brunswick E2A 4X7, Canada
  • Ottawa, Ontario K1H7W9, Canada
  • Toronto, Ontario M4S 1Y2, Canada
  • Mirabel, Quebec J7J 1L2, Canada
  • Montreal, Quebec H1T 1P6, Canada
  • Montreal, Quebec H2X 1N8, Canada
  • Pointe-Claire, Quebec H9R 4S3, Canada
  • Shawinigan, Quebec G9N 2H6, Canada
  • Regina, Saskatchewan S4S 0A2, Canada
  • Quebec, G1S 2L6, Canada
  • Mexico, México 16720, Mexico
  • Monterrey, Nuevo Leon 64460, Mexico
  • Mexico Df, 11000, Mexico
09

References and documents

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. Erratum In: Obstet Gynecol. 2010 Oct;116(4):999. PubMed 20733445 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00360490
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Aug 4, 2006
Start date
Jul 2006
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
Nov 19, 2009
Last update
Dec 9, 2013

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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