Trial Outcomes & Findings for Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding (NCT NCT03642210)

NCT ID: NCT03642210

Last Updated: 2024-05-14

Results Overview

Number of participants who completed treatment with an End-of-Treatment menstrual blood loss of \<80 ml or ≤50% of baseline

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 105 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-05-14

Participant Flow

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.

Participant milestones

Measure	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
Overall Study STARTED	105
Overall Study Modified Intent to Treat (MITT)	89
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

Baseline characteristics by cohort

Measure	Levonorgestrel 52 mg Intrauterine System n=105 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system
Age, Continuous	35.4 years STANDARD_DEVIATION 8.3 • n=5 Participants
Age, Customized Age (years): <35	46 participants n=5 Participants
Age, Customized Age (years): ≥35	59 participants n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Parity Nulliparous	29 Participants n=5 Participants
Parity Parous	76 Participants n=5 Participants
BMI (kg/m^2), mean	31.1 (kg/m^2) STANDARD_DEVIATION 9.0 • n=5 Participants
BMI <25 kg/m^2	29 Participants n=5 Participants
BMI 25 - <30 kg/m^2	25 Participants n=5 Participants
BMI ≥30 kg/m^2	51 Participants n=5 Participants
Current Marital Status [N(%)] Never Married	40 Participants n=5 Participants
Current Marital Status [N(%)] Married	48 Participants n=5 Participants
Current Marital Status [N(%)] Divorced	12 Participants n=5 Participants
Current Marital Status [N(%)] Separated	5 Participants n=5 Participants
Smoking Status [N(%)] Never Smoked	67 Participants n=5 Participants
Smoking Status [N(%)] Ex-Smoker	18 Participants n=5 Participants
Smoking Status [N(%)] Current Smoker	20 Participants n=5 Participants
Baseline MBL, Mean	165.4 (mL) STANDARD_DEVIATION 79.1 • n=5 Participants
Baseline MBL, Median	143.2 (mL) n=5 Participants
BMI (kg/m^2), Median	29.7 (kg/m^2) n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants who completed treatment with an End-of-Treatment menstrual blood loss of <80 ml or ≤50% of baseline

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=89 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only Baseline Number of Days with Bleeding Only	Baseline Spotting Only Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Number of Participants With Successful Treatment of Heavy Menstrual Bleeding End-of-Treatment MBL < 80 mL	81 Participants	—	—	—	—	—	—	—	—
Number of Participants With Successful Treatment of Heavy Menstrual Bleeding Decrease in End-of-Treatment MBL to ≤ 50% of Baseline MBL	83 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 months

• Percent change from Baseline MBL to mid-treatment MBL Cycle 3 (28 days per cycle; approximately 3 months)

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=85 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only Baseline Number of Days with Bleeding Only	Baseline Spotting Only Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Menstrual Blood Loss - Percent Change From Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)	-93.3 Percent Change in Absolute MBL (%) Interval -100.0 to 10.3	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 months

• Absolute change in Baseline MBL to mid-treatment MBL Cycle 3 (28 Days Per Cycle; Approximately 3 Months)

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=85 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only Baseline Number of Days with Bleeding Only	Baseline Spotting Only Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Menstrual Blood Loss - Absolute Change in Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)	-127.8 mL Interval -421.4 to 53.8	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

• Absolute change from Baseline to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months)

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=89 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only Baseline Number of Days with Bleeding Only	Baseline Spotting Only Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Menstrual Blood Loss - Absolute Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)	-127.0 mL Interval -427.6 to 79.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

• Percent change from Baseline MBL to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months)

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=89 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only Baseline Number of Days with Bleeding Only	Baseline Spotting Only Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Menstrual Blood Loss - Percent Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)	-97.6 Percent Change in Absolute MBL (%) Interval -100.0 to 57.9	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=87 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only n=87 Participants Baseline Number of Days with Bleeding Only	Baseline Spotting Only n=87 Participants Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting n=88 Participants Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only n=88 Participants Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only n=88 Participants Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting n=79 Participants Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only n=79 Participants Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only n=79 Participants Cycle 6 Number of Days with Spotting Only
Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6.	6.5 days Interval 3.6 to 13.0	4.5 days Interval 2.0 to 11.0	1.5 days Interval 0.0 to 5.3	9.0 days Interval 0.0 to 28.0	3.0 days Interval 0.0 to 20.0	5.5 days Interval 0.0 to 28.0	6.0 days Interval 0.0 to 28.0	1.0 days Interval 0.0 to 25.0	3.0 days Interval 0.0 to 25.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=92 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only n=79 Participants Baseline Number of Days with Bleeding Only	Baseline Spotting Only n=76 Participants Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Blood Changes - Hemoglobin	3.5 % change of hemoglobin (g/dL) Interval -55.6 to 89.9	5.5 % change of hemoglobin (g/dL) Interval -11.0 to 42.1	3.9 % change of hemoglobin (g/dL) Interval -15.0 to 123.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=92 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only n=81 Participants Baseline Number of Days with Bleeding Only	Baseline Spotting Only n=78 Participants Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Blood Changes - Hematocrit	2.5 Hematocrit % Interval -12.8 to 57.5	4.5 Hematocrit % Interval -12.4 to 32.2	2.2 Hematocrit % Interval -16.9 to 27.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

Change in serum ferritin from Baseline to mid-treatment (approximately 3 months) and to end-of-treatment (approximately 6 months).

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=105 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only n=92 Participants Baseline Number of Days with Bleeding Only	Baseline Spotting Only n=82 Participants Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Blood Changes - Ferritin	30.2 ng/mL Standard Deviation 154.5	19.0 ng/mL Standard Deviation 18.1	22.4 ng/mL Standard Deviation 17.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

Number of Participants that Discontinued vs Completed Full Treatment Duration.

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=105 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only Baseline Number of Days with Bleeding Only	Baseline Spotting Only Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Number of Participants That Discontinued vs Completed Full Treatment Duration Safety Population	105 Participants	—	—	—	—	—	—	—	—
Number of Participants That Discontinued vs Completed Full Treatment Duration Discontinued After Failed Insertion	0 Participants	—	—	—	—	—	—	—	—
Number of Participants That Discontinued vs Completed Full Treatment Duration Completed Full Treatment Duration	82 Participants	—	—	—	—	—	—	—	—
Number of Participants That Discontinued vs Completed Full Treatment Duration Early Discontinuation	23 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=89 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only n=89 Participants Baseline Number of Days with Bleeding Only	Baseline Spotting Only n=89 Participants Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Participant Subjective Assessments How much cramping pain did you have? (10 cm = worst)	6.3 score on a scale in cm Interval 0.0 to 10.0	1.4 score on a scale in cm Interval 0.0 to 7.7	0.8 score on a scale in cm Interval 0.0 to 10.0	—	—	—	—	—	—
Participant Subjective Assessments How heavy was your bleeding? (10 cm = worst)	8.2 score on a scale in cm Interval 5.9 to 10.0	1.9 score on a scale in cm Interval 0.0 to 7.0	1.0 score on a scale in cm Interval 0.0 to 6.6	—	—	—	—	—	—
Participant Subjective Assessments How acceptable was your bleeding? (0 cm = worst)	1.8 score on a scale in cm Interval 0.0 to 9.8	8.7 score on a scale in cm Interval 0.0 to 10.0	9.2 score on a scale in cm Interval 0.0 to 10.0	—	—	—	—	—	—
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 Interval 0.6 to 9.7	0.5 score on a scale in cm Interval 0.0 to 8.0	0.2 score on a scale in cm Interval 0.0 to 10.0	—	—	—	—	—	—
Participant Subjective Assessments How much did it affect your ability to sleep? (10 cm = worst)	5.3 score on a scale in cm Interval 0.0 to 9.6	0.3 score on a scale in cm Interval 0.0 to 3.9	0.2 score on a scale in cm Interval 0.0 to 10.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Levonorgestrel 52 mg Intrauterine System n=87 Participants Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system	Baseline Bleeding Only n=78 Participants Baseline Number of Days with Bleeding Only	Baseline Spotting Only n=79 Participants Baseline Number of Days with Spotting Only	Cycle 3 Bleeding and/or Spotting Cycle 3 Number of Days Bleeding with and/or Spotting	Cycle 3 Bleeding Only Cycle 3 Number of Days with Bleeding Only	Cycle 3 Spotting Only Cycle 3 Number of Days with Spotting Only	Cycle 6 Bleeding and/or Spotting Cycle 6 Number of Days with Bleeding and/or Spotting	Cycle 6 Bleeding Only Cycle 6 Number of Days with Bleeding Only	Cycle 6 Spotting Only Cycle 6 Number of Days with Spotting Only
Changes in Number of Bleeding Episodes	0 Bleeding Episodes Interval -1.5 to 2.5	-0.9 Bleeding Episodes Interval -1.5 to 1.5	0 Bleeding Episodes Interval -3.0 to 1.0	—	—	—	—	—	—

Adverse Events

Levonorgestrel 52 mg Intrauterine System

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Levonorgestrel 52 mg Intrauterine System n=105 participants at risk Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Levonorgestrel 52 mg intrauterine system: Levonorgestrel 52 mg intrauterine system
Gastrointestinal disorders Nausea	2.9% 3/105 • Number of events 3 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Bacterial vaginosis	8.6% 9/105 • Number of events 9 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications Post procedural haemorrhage	2.9% 3/105 • Number of events 3 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications Procedural pain	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Product Issues Device expulsion	8.6% 9/105 • Number of events 9 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders Pelvic pain	3.8% 4/105 • Number of events 4 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders Vaginal discharge	2.9% 3/105 • Number of events 3 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders Acne	2.9% 3/105 • Number of events 3 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders Diarrhoea	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders Iron deficiency anaemia	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Nasopharyngitis	1.9% 2/105 • Number of events 3 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Pneumonia	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Urinary tract infection	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations Vulvovaginal mycotic infection	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders Headache	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders Dysmenorrhoea	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders Metrorrhagia	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders Uterine spasm	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders Vaginal odour	1.9% 2/105 • Number of events 2 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders Vulvovaginal pruritus	1.9% 2/105 • Number of events 3 • 6 months An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Additional Information

Emily Morris

Medicines360

Phone: 415.951.8700

Email: emorris@medicines360.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60