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Completed

NCT Number: NCT00360490

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

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

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel IUS (Mirena, BAY86-5028)

Drug

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

Medroxyprogesterone Acetate

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Percent Change From Baseline MBL to End of Study MBL (Cycle 6)

    Time frame: Baseline and up to 6 months

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

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

    Time frame: Baseline and up to 3 months

    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.

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

    Time frame: Baseline and up to 3 months

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

  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

    Time frame: Baseline and up to 6 months

    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.

  6. Total Number of Spotting and Bleeding Days

    Time frame: Baseline and up to 6 months

    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.

  7. Total Number of Spotting Days

    Time frame: Baseline and up to 6 months

    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.

  8. Total Number of Bleeding Episodes

    Time frame: Baseline and up to 6 months

    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.

  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

    Time frame: Up to 6 months

    "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'

  13. Percentage of Patients With Improvement in the Patients Overall Assessment Scale

    Time frame: Up to 6 months

    "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'.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 4, 2006
Registry last updated
Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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