Menorrhagia
Conditions
Brief summary
To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy menstrual bleeding.
Detailed description
This study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding.
Interventions
COMBINATION_PRODUCTLevonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system
Sponsors
Medicines360
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent * Reports subjectively heavy menses for most menses when not using hormonal contraception or a copper IUD * Healthy females 18-50 years old, inclusive, at the time of enrollment * Able to read and write, as determined by study personnel * FSH value ≤30 mIU/mL at screening * Typical menstrual cycle length of 21-35 days with variation from cycle to cycle of typically 5 days or less * Has menstrual blood loss in 2 of the 3 cycles during the Screening Phase with ≥ 80 mL per cycle as measured by the AH method * Uterine sound depth of ≥5.5 cm * Willing to comply with study visit schedule and assessments, including sanitary product collection and diary completion requirements * Documented (i.e., printed report) Pap testing, regardless of subject's age, and any indicated evaluation/treatment that demonstrates no need for further evaluation during the course of study participation (i.e., within 10 months after consent) * Planning to reside within a reasonable driving distance of a research site (approximately 150 miles) for duration of study participation * Willing to use a medication other than a NSAID as first-line treatment for any pain condition during the duration of study participation * Willing to abstain from heterosexual intercourse or use acceptable contraception during the screening phase; acceptable contraception includes male or female permanent contraception, withdrawal (if has been using as current method prior to screening) or a barrier method * If previously pregnant, at least one subjectively heavy menses prior to screening
Exclusion criteria
* Currently pregnant * Planning to attempt to become pregnant during the screening and treatment phases of study participation (i.e., up to approximately 11 months after consent) * Currently lactating or not having a subjectively heavy menses since discontinuation of lactation prior to screening * Clinical diagnosis of perimenopause (in the opinion of the investigator) based on one or more of the following: changes in menstrual regularity (e.g., shorter, longer, absent, irregular), hot flashes, sleeping disorder, or changes in mood (e.g., depression, nervous tension, and irritability) within 3 months prior to or during the screening period * Screening blood laboratory value outside of the normal range that, in the opinion of the investigator, requires treatment or further work-up (i.e., are considered clinically significant) * Has poor venous access or significant history of inability to have blood samples drawn * Body habitus or history of lower genital tract abnormalities or prior surgeries which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented * History of bicornuate uterus or any other abnormality of the uterus resulting in distortion of the uterine cavity or cervical canal incompatible with insertion * Prior (documented within 6 months) or baseline study ultrasound examination demonstrating: * A congenital or acquired uterine anomaly that distorts the uterine cavity or cervical canal incompatible with insertion; * Endometrial polyps (unless previously removed), * Fibroids meeting any of the following criteria: Distort the uterine cavity or cervical canal incompatible with insertion; Submucosal location; Exceeding 2 cm in the greatest dimension for any individual fibroid; More than three fibroids of at least 1.5 cm in greatest diameter * Clear evidence of adenomyosis consisting of any of the following: Subendometrial cysts; Diffuse adenomyosis based on a heterogeneous myometrial echotexture consisting of Hyperechoic findings (islands of endometrial glands), hypoechoic findings (associated muscle hypertrophy), or Venetian blind appearance due to subendometrial echogenic linear striations and acoustic shadowing where endometrial tissues cause a hyperplastic reaction. * Recently diagnosed or clinically evident cervicitis or upper genital tract infection at the time of IUS insertion (unless successfully treated and considered clinically cured for at least 7 days prior to enrollment) * History of pelvic actinomycosis infection (i.e., received antibiotic treatment; criterion does not include solely a history of Pap test with actinomyces) * Postpartum or post-abortion endometritis unless symptoms resolved at least 4 weeks prior to screening * Chronic endometritis on endometrial biopsy at screening (an endometrial biopsy performed within 6 months of Visit 1 could be used if a report is available with a tissue diagnosis) * Has any of the following premalignant or malignant diseases: * Malignant melanoma * Acute malignancies affecting blood or leukemias * Gestational trophoblastic disease (unless at least one year with undetectable beta-hCG) * Known or suspected cervical, ovarian, vaginal or vulvar cancer * Uterine cancer or evidence of uterine malignancy, endometrial intraepithelial neoplasia (EIN) or hyperplasia on an endometrial biopsy at screening (an endometrial biopsy performed within 6 months of Visit 1 could be used if a report is available with a tissue diagnosis) * History of breast cancer, or suspicion of breast cancer until proven otherwise * Has any of the following medical conditions: * Bleeding diathesis (inherited or acquired) * History of von Willebrand's disease or other known coagulopathy * Uncontrolled significant hypertension defined as a sitting systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 95 mm Hg at any screening or enrollment visit unless treated and controlled within two weeks of discovery * Presence or history of venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), presence or history of arterial thromboembolic diseases (e.g., myocardial infarction, stroke) * Uncontrolled thyroid disorder * Sickle cell anemia * Diabetes mellitus that is poorly controlled or with end-organ/vascular complications * Hyperprolactinemia at screening * Acute or severe liver disease or liver tumor * Poorly controlled bipolar disorder, schizophrenia, psychosis, major depressive disorder or other major psychiatric disorder according the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-5) * History of a positive HIV test or having a partner who is known to be HIV positive * Current or history of alcohol, illicit drug or prescription drug abuse within 12 months prior to screening * Use of antifibrinolytics, platelet aggregation inhibitors, anticoagulants or other similar medications that can increase or decrease bleeding within 30 days prior to and during the screening (EXCEPTION: NSAIDs can be used as second-line treatment for pain management) * Use of intrauterine or implantable contraception, progestin-only pills, combined hormonal contraceptives or oral progestin therapy within 30 days before screening * Depomedroxyprogesterone acetate (DMPA) injection within the past 9 months prior to screening (this exclusionary time period can be shortened to 6 months if the subject has also had two spontaneous menstrual cycles \[requires minimum of 3 heavy menses\] that meet criteria for normal menstrual cycle pattern) * Use of non-contraceptive estrogen, progesterone, progestin, testosterone, androgen or other gonadotropins (e.g. hCG) within 30 days before screening * Prior total or partial endometrial ablation or resection * History of a uterine aspiration or curettage procedure for any indication (other than an office biopsy) within 4 weeks of screening * Known or suspected allergy to levonorgestrel or hypersensitivity to any component of the product * Use of an experimental medication or receipt of an experimental treatment for any condition within 30 days of screening * Study staff or a member of the immediate family of a study staff * Any condition or circumstance that, in the opinion of the Investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as any concurrent medical condition that is not stable and well-controlled, that is likely to worsen, or that may require recurrent hospitalizations during study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Treatment of Heavy Menstrual Bleeding | 6 months | Number of participants who completed treatment with an End-of-Treatment menstrual blood loss of \<80 ml or ≤50% of baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual Blood Loss - Absolute Change in Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months) | 3 months | • Absolute change in Baseline MBL to mid-treatment MBL Cycle 3 (28 Days Per Cycle; Approximately 3 Months) |
| Menstrual Blood Loss - Absolute Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months) | 6 months | • Absolute change from Baseline to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months) |
| Menstrual Blood Loss - Percent Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months) | 6 months | • Percent change from Baseline MBL to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months) |
| Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 6 months | Number of days bleeding, spotting, and bleeding and/or spotting at Baseline, Cycle 3 (approximately 3 months), and Cycle 6 (approximately 6 months). |
| Blood Changes - Hemoglobin | 6 months | • Percent change in hemoglobin from Baseline to mid-treatment (approximately 3 months), from Baseline to end-of-treatment (approximately 6 months), and from mid-treatment to end-of-treatment (approximately 3 months). |
| Menstrual Blood Loss - Percent Change From Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months) | 3 months | • Percent change from Baseline MBL to mid-treatment MBL Cycle 3 (28 days per cycle; approximately 3 months) |
| Blood Changes - Ferritin | 6 months | Change in serum ferritin from Baseline to mid-treatment (approximately 3 months) and to end-of-treatment (approximately 6 months). |
| Number of Participants That Discontinued vs Completed Full Treatment Duration | 6 months | Number of Participants that Discontinued vs Completed Full Treatment Duration. |
| Participant Subjective Assessments | 6 months | • Subjective assessment of menstrual bleeding changes based on VAS questionnaires of Safety and Continuation Rates from Baseline to Treatment Cycle 3 (approximately 3 months) to Cycle 6 (approximately 6 months). Participants responded to various questions regarding their menstrual bleeding on Visual Analog Scales (VAS), with Not Acceptable at 0 cm and Completely Acceptable at 10 cm. |
| Changes in Number of Bleeding Episodes | 6 months | • Changes from Baseline to mid-treatment Cycle 3 (approximately 3 months), from Baseline to end of treatment Cycle 6 (approximately 6 months), and from mid-treatment Cycle 3 to end of treatment Cycle 6 in the number of bleeding episodes. Bleeding episodes are defined as all bleeding days separated by no more than one bleeding-free day. |
| Blood Changes - Hematocrit | 6 months | • Percent change in hematocrit from Baseline to mid-treatment (approximately 3 months), from Baseline to end-of-treatment (approximately 6 months), and from mid-treatment to end-of-treatment (approximately 3 months). |
Countries
United States
Participant flow
Pre-assignment details
105 eligible women, 18-50 years of age, were enrolled to receive LNG20 IUS. This study did not restrict enrollment based on parity, weight or BMI. Women who did not require contraception (e.g., not heterosexually active, using permanent contraception) were included.
Participants by arm
| Arm | Count |
|---|---|
| Levonorgestrel 52 mg Intrauterine System Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months
Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system | 105 |
| Total | 105 |
Baseline characteristics
| Characteristic | Levonorgestrel 52 mg Intrauterine System |
|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 8.3 |
| Age, Customized Age (years): <35 | 46 participants |
| Age, Customized Age (years): ≥35 | 59 participants |
| Baseline MBL, Mean | 165.4 (mL) STANDARD_DEVIATION 79.1 |
| Baseline MBL, Median | 143.2 (mL) |
| BMI 25 - <30 kg/m^2 | 25 Participants |
| BMI <25 kg/m^2 | 29 Participants |
| BMI ≥30 kg/m^2 | 51 Participants |
| BMI (kg/m^2), mean | 31.1 (kg/m^2) STANDARD_DEVIATION 9 |
| BMI (kg/m^2), Median | 29.7 (kg/m^2) |
| Current Marital Status [N(%)] Divorced | 12 Participants |
| Current Marital Status [N(%)] Married | 48 Participants |
| Current Marital Status [N(%)] Never Married | 40 Participants |
| Current Marital Status [N(%)] Separated | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Parity Nulliparous | 29 Participants |
| Parity Parous | 76 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 68 Participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 0 Participants |
| Smoking Status [N(%)] Current Smoker | 20 Participants |
| Smoking Status [N(%)] Ex-Smoker | 18 Participants |
| Smoking Status [N(%)] Never Smoked | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 105 |
| other Total, other adverse events | 49 / 105 |
| serious Total, serious adverse events | 0 / 105 |
Outcome results
Primary
Number of Participants With Successful Treatment of Heavy Menstrual Bleeding
Number of participants who completed treatment with an End-of-Treatment menstrual blood loss of \<80 ml or ≤50% of baseline
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Number of Participants With Successful Treatment of Heavy Menstrual Bleeding | End-of-Treatment MBL < 80 mL | 81 Participants |
| Levonorgestrel 52 mg Intrauterine System | Number of Participants With Successful Treatment of Heavy Menstrual Bleeding | Decrease in End-of-Treatment MBL to ≤ 50% of Baseline MBL | 83 Participants |
Secondary
Blood Changes - Ferritin
Change in serum ferritin from Baseline to mid-treatment (approximately 3 months) and to end-of-treatment (approximately 6 months).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Blood Changes - Ferritin | 30.2 ng/mL | Standard Deviation 154.5 |
| Baseline Bleeding Only | Blood Changes - Ferritin | 19.0 ng/mL | Standard Deviation 18.1 |
| Baseline Spotting Only | Blood Changes - Ferritin | 22.4 ng/mL | Standard Deviation 17.6 |
Secondary
Blood Changes - Hematocrit
• Percent change in hematocrit from Baseline to mid-treatment (approximately 3 months), from Baseline to end-of-treatment (approximately 6 months), and from mid-treatment to end-of-treatment (approximately 3 months).
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Blood Changes - Hematocrit | 2.5 Hematocrit % |
| Baseline Bleeding Only | Blood Changes - Hematocrit | 4.5 Hematocrit % |
| Baseline Spotting Only | Blood Changes - Hematocrit | 2.2 Hematocrit % |
Secondary
Blood Changes - Hemoglobin
• Percent change in hemoglobin from Baseline to mid-treatment (approximately 3 months), from Baseline to end-of-treatment (approximately 6 months), and from mid-treatment to end-of-treatment (approximately 3 months).
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Blood Changes - Hemoglobin | 3.5 % change of hemoglobin (g/dL) |
| Baseline Bleeding Only | Blood Changes - Hemoglobin | 5.5 % change of hemoglobin (g/dL) |
| Baseline Spotting Only | Blood Changes - Hemoglobin | 3.9 % change of hemoglobin (g/dL) |
Secondary
Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6.
Number of days bleeding, spotting, and bleeding and/or spotting at Baseline, Cycle 3 (approximately 3 months), and Cycle 6 (approximately 6 months).
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 6.5 days |
| Baseline Bleeding Only | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 4.5 days |
| Baseline Spotting Only | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 1.5 days |
| Cycle 3 Bleeding and/or Spotting | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 9.0 days |
| Cycle 3 Bleeding Only | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 3.0 days |
| Cycle 3 Spotting Only | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 5.5 days |
| Cycle 6 Bleeding and/or Spotting | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 6.0 days |
| Cycle 6 Bleeding Only | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 1.0 days |
| Cycle 6 Spotting Only | Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6. | 3.0 days |
Secondary
Changes in Number of Bleeding Episodes
• Changes from Baseline to mid-treatment Cycle 3 (approximately 3 months), from Baseline to end of treatment Cycle 6 (approximately 6 months), and from mid-treatment Cycle 3 to end of treatment Cycle 6 in the number of bleeding episodes. Bleeding episodes are defined as all bleeding days separated by no more than one bleeding-free day.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Changes in Number of Bleeding Episodes | 0 Bleeding Episodes |
| Baseline Bleeding Only | Changes in Number of Bleeding Episodes | -0.9 Bleeding Episodes |
| Baseline Spotting Only | Changes in Number of Bleeding Episodes | 0 Bleeding Episodes |
Secondary
Menstrual Blood Loss - Absolute Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
• Absolute change from Baseline to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Menstrual Blood Loss - Absolute Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months) | -127.0 mL |
Secondary
Menstrual Blood Loss - Absolute Change in Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
• Absolute change in Baseline MBL to mid-treatment MBL Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Menstrual Blood Loss - Absolute Change in Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months) | -127.8 mL |
Secondary
Menstrual Blood Loss - Percent Change From Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
• Percent change from Baseline MBL to mid-treatment MBL Cycle 3 (28 days per cycle; approximately 3 months)
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Menstrual Blood Loss - Percent Change From Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months) | -93.3 Percent Change in Absolute MBL (%) |
Secondary
Menstrual Blood Loss - Percent Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
• Percent change from Baseline MBL to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Menstrual Blood Loss - Percent Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months) | -97.6 Percent Change in Absolute MBL (%) |
Secondary
Number of Participants That Discontinued vs Completed Full Treatment Duration
Number of Participants that Discontinued vs Completed Full Treatment Duration.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Number of Participants That Discontinued vs Completed Full Treatment Duration | Safety Population | 105 Participants |
| Levonorgestrel 52 mg Intrauterine System | Number of Participants That Discontinued vs Completed Full Treatment Duration | Discontinued After Failed Insertion | 0 Participants |
| Levonorgestrel 52 mg Intrauterine System | Number of Participants That Discontinued vs Completed Full Treatment Duration | Completed Full Treatment Duration | 82 Participants |
| Levonorgestrel 52 mg Intrauterine System | Number of Participants That Discontinued vs Completed Full Treatment Duration | Early Discontinuation | 23 Participants |
Secondary
Participant Subjective Assessments
• Subjective assessment of menstrual bleeding changes based on VAS questionnaires of Safety and Continuation Rates from Baseline to Treatment Cycle 3 (approximately 3 months) to Cycle 6 (approximately 6 months). Participants responded to various questions regarding their menstrual bleeding on Visual Analog Scales (VAS), with Not Acceptable at 0 cm and Completely Acceptable at 10 cm.
Time frame: 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Levonorgestrel 52 mg Intrauterine System | Participant Subjective Assessments | How acceptable was your bleeding? (0 cm = worst) | 1.8 score on a scale in cm |
| Levonorgestrel 52 mg Intrauterine System | Participant Subjective Assessments | How much did it interfere with your ability to do daily activities? (10 cm = worst) | 6.2 score on a scale in cm |
| Levonorgestrel 52 mg Intrauterine System | Participant Subjective Assessments | How much did it affect your ability to sleep? (10 cm = worst) | 5.3 score on a scale in cm |
| Levonorgestrel 52 mg Intrauterine System | Participant Subjective Assessments | How heavy was your bleeding? (10 cm = worst) | 8.2 score on a scale in cm |
| Levonorgestrel 52 mg Intrauterine System | Participant Subjective Assessments | How much cramping pain did you have? (10 cm = worst) | 6.3 score on a scale in cm |
| Baseline Bleeding Only | Participant Subjective Assessments | How much cramping pain did you have? (10 cm = worst) | 1.4 score on a scale in cm |
| Baseline Bleeding Only | Participant Subjective Assessments | How acceptable was your bleeding? (0 cm = worst) | 8.7 score on a scale in cm |
| Baseline Bleeding Only | Participant Subjective Assessments | How much did it interfere with your ability to do daily activities? (10 cm = worst) | 0.5 score on a scale in cm |
| Baseline Bleeding Only | Participant Subjective Assessments | How much did it affect your ability to sleep? (10 cm = worst) | 0.3 score on a scale in cm |
| Baseline Bleeding Only | Participant Subjective Assessments | How heavy was your bleeding? (10 cm = worst) | 1.9 score on a scale in cm |
| Baseline Spotting Only | Participant Subjective Assessments | How much did it affect your ability to sleep? (10 cm = worst) | 0.2 score on a scale in cm |
| Baseline Spotting Only | Participant Subjective Assessments | How heavy was your bleeding? (10 cm = worst) | 1.0 score on a scale in cm |
| Baseline Spotting Only | Participant Subjective Assessments | How much did it interfere with your ability to do daily activities? (10 cm = worst) | 0.2 score on a scale in cm |
| Baseline Spotting Only | Participant Subjective Assessments | How acceptable was your bleeding? (0 cm = worst) | 9.2 score on a scale in cm |
| Baseline Spotting Only | Participant Subjective Assessments | How much cramping pain did you have? (10 cm = worst) | 0.8 score on a scale in cm |