Trial Outcomes & Findings for Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer (NCT NCT01439945)

Last Updated: 2017-04-04

Results Overview

The primary endpoint is the intra-patient changes of weekly hot flash activity from baseline during the treatment period. The hot flash activity will be measured by the weekly average hot flash score, which is a composite entity of both frequency and severity of hot flashes. The hot flash severity is graded from 1 to 4 (1=mild, 2=moderate, 3=severe, and 4=very severe). The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The weekly hot flash score was calculated by adding all scores for the week. The mean Hot Flash Score for each week for each group is reported and a repeated measures analysis is reported comparing each dose level group to the Placebo group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

289 participants

Primary outcome timeframe

Baseline to Week 8

Results posted on

2017-04-04

Participant Flow

After the double blind phase patient were allowed to re-registered on the Optional Continuation Phase of the study. This phase lasted up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.

Participant milestones

Participant milestones
Measure	Low Dose Magnesium Oxide (800 mg/Day) Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Low Dose Placebo Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two placebo tablets daily (QD).	High Dose Placebo Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take three placebo tablets daily (QD).
Double-Blind Treatment Phase STARTED	97	96	48	48
Double-Blind Treatment Phase COMPLETED	93	91	45	46
Double-Blind Treatment Phase NOT COMPLETED	4	5	3	2
Optional Continuation Phase STARTED	72	44	0	0
Optional Continuation Phase COMPLETED	72	44	0	0
Optional Continuation Phase NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Dose Magnesium Oxide (800 mg/Day) Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Low Dose Placebo Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two placebo tablets daily (QD).	High Dose Placebo Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take three placebo tablets daily (QD).
Double-Blind Treatment Phase Withdrawal by Subject	3	3	3	1
Double-Blind Treatment Phase Ineligible	1	2	0	1

Baseline Characteristics

Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Magnesium Oxide (800 mg/Day) n=93 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) n=91 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Placebo n=91 Participants Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis. Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two or three placebo tablets daily (QD).	Total n=275 Participants Total of all reporting groups
Age, Customized Age Group · 18-49 years	15 Participants n=93 Participants	15 Participants n=4 Participants	15 Participants n=27 Participants	45 Participants n=483 Participants
Age, Customized Age Group · >=50	78 Participants n=93 Participants	76 Participants n=4 Participants	76 Participants n=27 Participants	230 Participants n=483 Participants
Sex: Female, Male Female	93 Participants n=93 Participants	91 Participants n=4 Participants	91 Participants n=27 Participants	275 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	93 participants n=93 Participants	91 participants n=4 Participants	91 participants n=27 Participants	275 participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.

Outcome measures

Outcome measures
Measure	Low Dose Magnesium Oxide (800 mg/Day) n=88 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) n=88 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Placebo n=91 Participants Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis. Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two or three placebo tablets daily (QD).
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Baseline	16.02 units on a scale Standard Deviation 9.62	15.35 units on a scale Standard Deviation 10.53	17.28 units on a scale Standard Deviation 10.84
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Week 2	12.68 units on a scale Standard Deviation 8.87	12.59 units on a scale Standard Deviation 10.01	13.29 units on a scale Standard Deviation 9.46
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Week 4	11.73 units on a scale Standard Deviation 10.35	10.14 units on a scale Standard Deviation 8.61	12.02 units on a scale Standard Deviation 9.57
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Week 5	11.77 units on a scale Standard Deviation 10.86	9.73 units on a scale Standard Deviation 9.19	11.63 units on a scale Standard Deviation 9.61
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Week 8	12.17 units on a scale Standard Deviation 10.88	9.06 units on a scale Standard Deviation 8.87	11.42 units on a scale Standard Deviation 10.32
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Week 1	14.28 units on a scale Standard Deviation 9.26	14.47 units on a scale Standard Deviation 11.10	15.52 units on a scale Standard Deviation 10.51
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Week 3	12.29 units on a scale Standard Deviation 9.79	11.32 units on a scale Standard Deviation 10.72	12.34 units on a scale Standard Deviation 9.98
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Week 6	11.61 units on a scale Standard Deviation 10.46	9.44 units on a scale Standard Deviation 8.99	11.17 units on a scale Standard Deviation 8.78
The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. Week 7	11.92 units on a scale Standard Deviation 11.26	9.37 units on a scale Standard Deviation 9.24	10.71 units on a scale Standard Deviation 8.68

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.

As part of the Hot Flash Diary, the number of hot flashes was recorded for each patient for each week. For this endpoint, the mean number of hot flashes for each group is reported. A repeated measure analysis comparing each dose level group and the Placebo is reported.

Outcome measures

Outcome measures
Measure	Low Dose Magnesium Oxide (800 mg/Day) n=88 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) n=88 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Placebo n=91 Participants Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis. Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two or three placebo tablets daily (QD).
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Baseline	8.48 number of hot flashes Standard Deviation 4.34	7.55 number of hot flashes Standard Deviation 3.89	8.89 number of hot flashes Standard Deviation 4.52
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Week 1	7.83 number of hot flashes Standard Deviation 4.34	7.15 number of hot flashes Standard Deviation 4.13	8.04 number of hot flashes Standard Deviation 4.59
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Week 8	6.61 number of hot flashes Standard Deviation 4.58	4.88 number of hot flashes Standard Deviation 4.02	6.38 number of hot flashes Standard Deviation 4.67
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Week 2	7.12 number of hot flashes Standard Deviation 4.18	6.51 number of hot flashes Standard Deviation 4.19	7.26 number of hot flashes Standard Deviation 4.65
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Week 3	6.73 number of hot flashes Standard Deviation 4.41	5.87 number of hot flashes Standard Deviation 4.21	6.97 number of hot flashes Standard Deviation 4.82
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Week 4	6.39 number of hot flashes Standard Deviation 4.51	5.34 number of hot flashes Standard Deviation 3.76	6.73 number of hot flashes Standard Deviation 4.44
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Week 5	6.31 number of hot flashes Standard Deviation 4.70	5.15 number of hot flashes Standard Deviation 4.00	6.45 number of hot flashes Standard Deviation 4.33
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Week 6	6.34 number of hot flashes Standard Deviation 4.56	4.95 number of hot flashes Standard Deviation 4.04	6.37 number of hot flashes Standard Deviation 4.30
Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period Week 7	6.43 number of hot flashes Standard Deviation 4.68	4.92 number of hot flashes Standard Deviation 4.13	6.18 number of hot flashes Standard Deviation 4.23

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: All patients that started protocol treatment and were evaluated for adverse events are included in this analysis.

Frequency and severity of adverse events reported by patients in weekly Symptom Experience Questionnaire and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.

Outcome measures

Outcome measures
Measure	Low Dose Magnesium Oxide (800 mg/Day) n=92 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) n=93 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Placebo n=92 Participants Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis. Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two or three placebo tablets daily (QD).
Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period. Grade 3+ Adverse Event	5 Participants	1 Participants	2 Participants
Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period. Grade 4+ Adverse Event	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to week 8

Population: All patients that started treatment and completed the Symptom Experience Questionnaire at baseline and Cycle 9 were included in this analysis.

We will use the Symptom Experience Questionnaire (SEQ) to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. The questionnaire is 14 questions and is based on a 0="Not at all" to 10="As bad as it can be" scale. The change of severity of symptoms as measured by the SEQ from baseline to treatment termination will be first summarized by descriptive statistics as a percent change from baseline.

Outcome measures

Outcome measures
Measure	Low Dose Magnesium Oxide (800 mg/Day) n=79 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) n=80 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Placebo n=82 Participants Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis. Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two or three placebo tablets daily (QD).
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Fatigue	0 percentage change Interval -100.0 to 70.0	0 percentage change Interval -40.0 to 70.0	0 percentage change Interval -30.0 to 80.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Nausea	0 percentage change Interval -50.0 to 70.0	0 percentage change Interval -70.0 to 50.0	0 percentage change Interval -60.0 to 50.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Decreased Appetite	0 percentage change Interval -10.0 to 50.0	0 percentage change Interval -20.0 to 20.0	0 percentage change Interval -40.0 to 30.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Stomach Pain	0 percentage change Interval -40.0 to 60.0	0 percentage change Interval -30.0 to 30.0	0 percentage change Interval -60.0 to 40.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Diarrhea	0 percentage change Interval -50.0 to 20.0	-5 percentage change Interval -90.0 to 50.0	0 percentage change Interval -80.0 to 50.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Dizziness	0 percentage change Interval -20.0 to 50.0	0 percentage change Interval -80.0 to 50.0	0 percentage change Interval -30.0 to 20.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Muscle Weakness	0 percentage change Interval -80.0 to 50.0	0 percentage change Interval -50.0 to 70.0	0 percentage change Interval -60.0 to 30.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Abnormal Sweating	10 percentage change Interval -80.0 to 90.0	10 percentage change Interval -50.0 to 80.0	10 percentage change Interval -80.0 to 80.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Constipation	0 percentage change Interval -70.0 to 70.0	0 percentage change Interval -50.0 to 100.0	0 percentage change Interval -50.0 to 70.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Muscle/Joint Aches	5 percentage change Interval -90.0 to 80.0	10 percentage change Interval -80.0 to 60.0	0 percentage change Interval -30.0 to 50.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Trouble Sleeping	10 percentage change Interval -40.0 to 80.0	40 percentage change Interval -50.0 to 70.0	10 percentage change Interval -40.0 to 100.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Negative mood change	0 percentage change Interval -50.0 to 50.0	0 percentage change Interval -30.0 to 60.0	0 percentage change Interval -70.0 to 80.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Trouble Concentrating	0 percentage change Interval -50.0 to 60.0	0 percentage change Interval -30.0 to 50.0	0 percentage change Interval -40.0 to 70.0
The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination Distress	10 percentage change Interval -60.0 to 100.0	20 percentage change Interval -60.0 to 70.0	10 percentage change Interval -60.0 to 80.0

SECONDARY outcome

Timeframe: Baseline to week 8

Population: All patients that began treatment and completed the HFRDI questionnaire at baseline and week 8 were used in this analysis.

We will use the Hot Flash Related Daily Interference Scale (HFRDIS) (SEQ) to evaluate the specific effect of hot flashes have on various life activities such as work, social, leisure and relationships while receiving treatment. The questionnaire is 10 questions and is based on a 0="Do not interfere" to 10="Completely interfere" scale. The weekly score is the summation of these 10 questions and therefore ranges from 0 to 100. The total change in severity of symptoms is calculated by subtracting the week 8 score from the baseline. Therefore, values below zero indicate a worsening of symptoms and values above zero indicate an improvement and has a maximum range of -100 to 100. A gatekeeper procedure, following a fixed-sequence hypothesis testing method, was used to examine the higher dose of magnesium vs. placebo first and then the lower dose of magnesium vs. placebo, if the former was statistically significant.

Outcome measures

Outcome measures
Measure	Low Dose Magnesium Oxide (800 mg/Day) n=73 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) n=74 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Placebo Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis. Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two or three placebo tablets daily (QD).
The Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS) From Baseline to Treatment Termination.	7 units on a scale Interval -26.0 to 45.0	8.5 units on a scale Interval -41.0 to 74.0	—

SECONDARY outcome

Timeframe: Baseline to week 8

Population: All patients that started protocol treatment and had serum magnesium levels obtained at baseline and week 9 were included in this analysis.

The intra-patient changes of magnesium level from baseline to the end of treatment period between magnesium oxide and placebo arms will be compared using a repeated measures model. Serum magnesium concentrations will be performed prior to study medication usage and during the last week of blinded study use. These will be obtained in the first 150 patients. Mean change in serum magnesium concentrations will be compared between the 3 study arms to determine whether there are any apparent changes in the patients receiving placebos vs the two magnesium doses.

Outcome measures

Outcome measures
Measure	Low Dose Magnesium Oxide (800 mg/Day) n=69 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) n=74 Participants Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Placebo n=72 Participants Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis. Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two or three placebo tablets daily (QD).
The Intra-patient Changes of Magnesium Level From Baseline to the End of Treatment Period Between Magnesium Oxide and Placebo Arms.	0.0 mg/dL Standard Deviation 0.2	0.1 mg/dL Standard Deviation 0.2	0.0 mg/dL Standard Deviation 0.2

Adverse Events

Low Dose Magnesium Oxide (800 mg/Day)

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

High Dose Magnesium Oxide (1200 mg/Day)

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Optional Continuation Phase

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Dose Magnesium Oxide (800 mg/Day) n=92 participants at risk Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).	High Dose Magnesium Oxide (1200 mg/Day) n=93 participants at risk Week 2: Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD). Week 3: Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD). Weeks 4-9: Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).	Placebo n=92 participants at risk Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis. Week 2: Patients take one placebo tablets orally (PO) daily (QD). Week 3: Patients take two placebo tablets daily (QD). Weeks 4-9: Patients take two or three placebo tablets daily (QD).	Optional Continuation Phase n=116 participants at risk After the double blind phase patient questionnaire booklet has been completed and returned to the investigator, the patient will be told whether she was on magnesium or placebo. If the patient wishes to continue or start the magnesium, and healthcare provider approves that this is an appropriate option, she may be registered on the Optional Continuation Phase of the study. This phase will last up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.
Gastrointestinal disorders Diarrhea	0.00% 0/92 All patients that began treatment and were assessed for adverse events (AEs) are reported. In the Low Dose arm, 97 patients were randomized, 5 were never assessed for AEs. In the High Dose arm, 96 patients were randomized, 3 patients were never assessed for AEs. In the placebo arms, 96 patients were randomized, 4 were never assessed for AEs. This leaves 92, 93, and 92 patients on Low Dose, High Dose and Placebo arms respectively assessed for Adverse events.	1.1% 1/93 • Number of events 1 All patients that began treatment and were assessed for adverse events (AEs) are reported. In the Low Dose arm, 97 patients were randomized, 5 were never assessed for AEs. In the High Dose arm, 96 patients were randomized, 3 patients were never assessed for AEs. In the placebo arms, 96 patients were randomized, 4 were never assessed for AEs. This leaves 92, 93, and 92 patients on Low Dose, High Dose and Placebo arms respectively assessed for Adverse events.	0.00% 0/92 All patients that began treatment and were assessed for adverse events (AEs) are reported. In the Low Dose arm, 97 patients were randomized, 5 were never assessed for AEs. In the High Dose arm, 96 patients were randomized, 3 patients were never assessed for AEs. In the placebo arms, 96 patients were randomized, 4 were never assessed for AEs. This leaves 92, 93, and 92 patients on Low Dose, High Dose and Placebo arms respectively assessed for Adverse events.	0.00% 0/116 All patients that began treatment and were assessed for adverse events (AEs) are reported. In the Low Dose arm, 97 patients were randomized, 5 were never assessed for AEs. In the High Dose arm, 96 patients were randomized, 3 patients were never assessed for AEs. In the placebo arms, 96 patients were randomized, 4 were never assessed for AEs. This leaves 92, 93, and 92 patients on Low Dose, High Dose and Placebo arms respectively assessed for Adverse events.

Other adverse events

Additional Information

Charles Lawrence Loprinzi, M.D.

Mayo Clinic

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60