iTOM: Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia

Sponsor
Abimbola Famuyide (Other)
Overall Status
Completed
CT.gov ID
NCT01165307
Collaborator
Hologic, Inc. (Industry)
77
1
2
74
1

Study Details

Study Description

Brief Summary

Excessive menstrual loss (menorrhagia) is a common condition that affects women of reproductive age, and can result in anemia, chronic fatigue and lost wages from work. The traditional first line management involves treatment with oral contraceptives or non-steroidal anti-inflammatory agents. Many women ultimately undergo hysterectomy, a major operative procedure associated with increased costs, loss of feeling of womanhood, debilitating complications and on rare occasions, death.

The newer global endometrial ablation (GEA) devices allow the destruction of the endometrial lining, without the removal of the uterus, in an ambulatory surgery setting. GEA offers a safe and effective alternative to hysterectomy with minimal risks and without unpleasant side-effects.

Presently, global endometrial ablation is offered as an alternative to hysterectomy, after medical intervention has failed. This study will determine the role of global endometrial ablation in the initial management of menorrhagia. Women seeking treatment for menorrhagia will be randomized to either the medical treatment arm or the global endometrial ablation arm.

This study will be the first to compare clinical efficacy and costs between oral contraceptive pills and global endometrial ablation in the initial management of menorrhagia and could potentially change the management of menorrhagia and impact millions of women who suffer from this condition.

Condition or Disease Intervention/Treatment Phase
  • Drug: Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills
  • Drug: Naproxen sodium pills
  • Device: NovaSure® Radiofrequency Endometrial Ablation
Phase 4

Detailed Description

Goal of study: To evaluate the safety, effectiveness as well as cost- effectiveness of Global Endometrial Ablation (GEA) as an initial treatment for menorrhagia.

Specific aim #1: To determine if global endometrial ablation (GEA) is more effective than medical therapy in the initial management of menorrhagia.

Specific aim #2: To determine disease-specific resource utilization and costs associated with the treatment alternatives and the cost effectiveness of global endometrial ablation (GEA) compared with medical treatment (oral contraceptive pills) in the initial management of menorrhagia.

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Medical Therapy

Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).

Drug: Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills
Each packet consists of a fixed dose of 30mcg estradiol and a 150mcg dose of levonorgestrel for the first 21 days of the cycle, followed by a 7 day pill free period. Subjects will be instructed to administer the pills orally, starting 5 days after the start of menstrual blood flow, continuing cyclically, thus allowing for withdrawal bleeding after the 21 day pill cycle.
Other Names:
  • Nordette®
  • Drug: Naproxen sodium pills
    As an alternative to oral contraceptive pills, subjects may take Naproxen 500 mg with onset of menses, then 250 mg three times daily for the duration of the menses (or maximum of five days)
    Other Names:
  • Naprosyn 250 mg tablets
  • Active Comparator: Radiofrequency Endometrial Ablation

    Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.

    Device: NovaSure® Radiofrequency Endometrial Ablation
    Radiofrequency endometrial ablation is performed in the outpatient surgery department. Subjects receive intravenous medication, determined by the attending anesthesiologist, sufficient to induce conscious sedation during the procedure.

    Outcome Measures

    Primary Outcome Measures

    1. Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC). [Measured at 12 months following initial treatment]

      The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.

    Secondary Outcome Measures

    1. Quality of Life Score Using the Short Form-12 (SF-12) Health Survey [Measured at 12 months following initial treatment]

      Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.

    2. Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS ) [Measured at 12 months following initial treatment]

      The MMAS questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).

    3. Hemoglobin at 12 Months [Measured at 12 months following initial treatment]

    4. Change in Hemoglobin [baseline, 12 months]

    5. Ferritin at 12 Months [Measured at 12 months following initial treatment]

    6. Change in Ferritin From Baseline [Measured at 12 months following initial treatment]

    7. Direct Medical Costs [Measured at 12 months following initial treatment]

      Direct Medical Costs consisted of two categories: primarily hospital billed services, and primarily physician billed services. Primary hospital billed services were as defined by Medicare billing practice.

    8. Indirect Medical Costs [Measured at 12 months following initial treatment]

      Indirect cost A refers to cost of sanitary products and lack of activity, indirect cost B refers to cost of sanitary products and reduced work days, and indirect cost C refers to cost of sanitary products, lack of activity, and reduced work days.

    9. Bleeding Pattern at 12 Months [Measured at 12 months following initial treatment]

      The menstruation pattern of the subjects was evaluated. A bleeding episode was defined as any set of one or more bleeding days bounded at each end by two or more bleeding-free days. The bleeding pattern was analyzed using a 90 day reference period and divided into groups, (based on World Health Organization (WHO) classification of clinically important bleeding patterns). The groups are Amenorrhea (no bleeding during the reference period); Infrequent bleeding (fewer than 3 bleeding episodes); Irregular bleeding (between 3 and 5 episodes with less than 3 bleeding-free intervals of length 14 days or more); Prolonged bleeding (1 or more bleeding episodes lasting 14 days or more); Eumenorrhea "normal pattern" (none of the above patterns).

    10. Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS) [Measured at 12 months following initial treatment]

      The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 100 mm in length. Possible scores range from 0 (no pain) to 100 (worst possible pain). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    11. Subject Satisfaction at 12 Months [Measured at 12 months following initial treatment]

      Subject satisfaction was ascertained by asking study participants to choose from one of four categories relating to their general satisfaction with treatment: totally satisfied, generally satisfied, acceptable improvement in symptoms, or unacceptable treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Adult female, ages 30-55, who is pre-menopausal and for whom childbearing is complete

    2. Subjective symptom of excessive menstrual loss

    3. Normal uterine cavity length (≥ 4cm) with a sound measurement of ≤10cm documented by sonohysterogram or hysteroscopy in the preceding 6 months

    4. At least one normal Pap Test and no unexplained abnormal Pap Tests within 6 months of procedure

    5. Prior history of permanent sterilization or use of reliable non-hormonal contraception during the 14 month study period or history of vasectomy in partner

    6. Freely agree to participate in the study including all study related procedures and evaluations, and document this agreement by signing the informed consent document

    Exclusion Criteria:
    1. Pregnancy or desire for future childbearing

    2. Active lower genital infection at the time of procedure

    3. Active urinary tract infection at the time of procedure

    4. Active pelvic inflammatory disease (PID) or recurrent chronic PID

    5. Endometrial neoplasia, determined by endometrial biopsy taken within 12 months of study entry

    6. Current or past history of cervical or endometrial cancer

    7. Uterine sound measurement greater than 10cm

    8. Submucous leiomyoma greater than 2cm or cavity distorting leiomyoma

    9. History of myomectomy or classical cesarean section

    10. Previous endometrial ablation

    11. Oral hormonal treatment in the preceding 3 months, hormone releasing intrauterine contraceptive in the preceding month, or injectable hormone treatment in the preceding 12 months

    12. Contraindication to hormonal therapy and non-steroidal anti-inflammatory agents.

    13. History of a coagulopathy or endocrinopathy

    14. Inability to follow up at 12 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Abimbola Famuyide
    • Hologic, Inc.

    Investigators

    • Principal Investigator: Abimbola O. Famuyide, MBBS, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abimbola Famuyide, Consultant, Assistant Professor of Obstetrics-Gynecology, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01165307
    Other Study ID Numbers:
    • 08-007334
    First Posted:
    Jul 19, 2010
    Last Update Posted:
    Jan 20, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Abimbola Famuyide, Consultant, Assistant Professor of Obstetrics-Gynecology, Mayo Clinic
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited at Mayo Clinic in Rochester, Minnesota from September 2009 to February 2013.
    Pre-assignment Detail 77 subjects were initially consented, but 10 subjects were not randomized because 4 declined participation after consent, 4 reported spontaneous improvement during initial evaluation, 1 had an abnormal Pap smear indicating treatment, and 1 had a polypoid mass on hysteroscopy.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Period Title: Overall Study
    STARTED 33 34
    COMPLETED 19 31
    NOT COMPLETED 14 3

    Baseline Characteristics

    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation Total
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan. Total of all reporting groups
    Overall Participants 33 34 67
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.8
    (5.5)
    41.9
    (6.0)
    42.3
    (5.8)
    Sex: Female, Male (Count of Participants)
    Female
    33
    100%
    34
    100%
    67
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    33
    100%
    34
    100%
    67
    100%

    Outcome Measures

    1. Primary Outcome
    Title Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).
    Description The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Median (Inter-Quartile Range) [units on a scale]
    15
    0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    2. Secondary Outcome
    Title Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
    Description Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    SF-12 Physical Scale
    54.2
    (5.9)
    54.5
    (4.2)
    SF-12 Mental Scale
    49.8
    (10.0)
    53.8
    (6.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments Comparison between the groups for the SF-12 Physical Scale.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.82
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments Comparison between the groups for the SF-12 mental scale.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    Comments
    Method t-test, 2 sided
    Comments
    3. Secondary Outcome
    Title Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )
    Description The MMAS questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Median (Inter-Quartile Range) [units on a scale]
    100
    100
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.12
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    4. Secondary Outcome
    Title Hemoglobin at 12 Months
    Description
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Median (Inter-Quartile Range) [g/dL]
    13.2
    13.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.38
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    5. Secondary Outcome
    Title Change in Hemoglobin
    Description
    Time Frame baseline, 12 months

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Median (Inter-Quartile Range) [g/dL]
    0.0
    0.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.12
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    6. Secondary Outcome
    Title Ferritin at 12 Months
    Description
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Median (Inter-Quartile Range) [ug/L]
    25.0
    26.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.60
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    7. Secondary Outcome
    Title Change in Ferritin From Baseline
    Description
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Median (Inter-Quartile Range) [ug/L]
    4.0
    10.0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.42
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    8. Secondary Outcome
    Title Direct Medical Costs
    Description Direct Medical Costs consisted of two categories: primarily hospital billed services, and primarily physician billed services. Primary hospital billed services were as defined by Medicare billing practice.
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Primarily hospital billed services
    1300
    (1170)
    3494
    (4006)
    Primarily physician billed services
    1601
    (1576)
    1837
    (1602)
    9. Secondary Outcome
    Title Indirect Medical Costs
    Description Indirect cost A refers to cost of sanitary products and lack of activity, indirect cost B refers to cost of sanitary products and reduced work days, and indirect cost C refers to cost of sanitary products, lack of activity, and reduced work days.
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Indirect costs A
    741
    (1174)
    124
    (403)
    Indirect costs B
    264
    (467)
    27
    (79)
    Indirect costs C
    968
    (1534)
    138
    (421)
    10. Secondary Outcome
    Title Bleeding Pattern at 12 Months
    Description The menstruation pattern of the subjects was evaluated. A bleeding episode was defined as any set of one or more bleeding days bounded at each end by two or more bleeding-free days. The bleeding pattern was analyzed using a 90 day reference period and divided into groups, (based on World Health Organization (WHO) classification of clinically important bleeding patterns). The groups are Amenorrhea (no bleeding during the reference period); Infrequent bleeding (fewer than 3 bleeding episodes); Irregular bleeding (between 3 and 5 episodes with less than 3 bleeding-free intervals of length 14 days or more); Prolonged bleeding (1 or more bleeding episodes lasting 14 days or more); Eumenorrhea "normal pattern" (none of the above patterns).
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Amenorrhea
    5
    15.2%
    16
    47.1%
    Irregular/Infrequent bleeding
    4
    12.1%
    6
    17.6%
    Prolonged bleeding
    2
    6.1%
    0
    0%
    Eumenorrhea
    8
    24.2%
    9
    26.5%
    11. Secondary Outcome
    Title Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)
    Description The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 100 mm in length. Possible scores range from 0 (no pain) to 100 (worst possible pain). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Median (Inter-Quartile Range) [mm]
    0.4
    0.0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Medical Therapy, Radiofrequency Endometrial Ablation
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.08
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    12. Secondary Outcome
    Title Subject Satisfaction at 12 Months
    Description Subject satisfaction was ascertained by asking study participants to choose from one of four categories relating to their general satisfaction with treatment: totally satisfied, generally satisfied, acceptable improvement in symptoms, or unacceptable treatment.
    Time Frame Measured at 12 months following initial treatment

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the 12 month visit were included in the analysis.
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    Measure Participants 19 31
    Totally satisfied
    12
    36.4%
    30
    88.2%
    Generally satisfied
    4
    12.1%
    1
    2.9%
    Acceptable improvement
    2
    6.1%
    0
    0%
    Unacceptable
    1
    3%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Medical Therapy Radiofrequency Endometrial Ablation
    Arm/Group Description Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days). Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
    All Cause Mortality
    Medical Therapy Radiofrequency Endometrial Ablation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Medical Therapy Radiofrequency Endometrial Ablation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/33 (0%) 0/34 (0%)
    Other (Not Including Serious) Adverse Events
    Medical Therapy Radiofrequency Endometrial Ablation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/33 (36.4%) 1/34 (2.9%)
    Blood and lymphatic system disorders
    Extremity edema 1/33 (3%) 1 0/34 (0%) 0
    Cardiac disorders
    Increased blood pressure 1/33 (3%) 1 0/34 (0%) 0
    Gastrointestinal disorders
    Gastrointestinal adverse events 2/33 (6.1%) 2 0/34 (0%) 0
    General disorders
    Mild headache 2/33 (6.1%) 2 0/34 (0%) 0
    Moderate headache 4/33 (12.1%) 4 0/34 (0%) 0
    Weight gain 1/33 (3%) 1 0/34 (0%) 0
    Psychiatric disorders
    Depression 1/33 (3%) 1 0/34 (0%) 0
    Renal and urinary disorders
    Urinary tract infection 0/33 (0%) 0 1/34 (2.9%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Abimbola O. Famuyide
    Organization Mayo Clinic
    Phone 507-284-7035
    Email Famuyide.Abimbola@mayo.edu
    Responsible Party:
    Abimbola Famuyide, Consultant, Assistant Professor of Obstetrics-Gynecology, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01165307
    Other Study ID Numbers:
    • 08-007334
    First Posted:
    Jul 19, 2010
    Last Update Posted:
    Jan 20, 2017
    Last Verified:
    Jan 1, 2017