Trial Outcomes & Findings for Chronic Pain Risk Associated With Menstrual Period Pain (NCT NCT02214550)
NCT ID: NCT02214550
Last Updated: 2023-06-18
Results Overview
Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the initial, 6 month and 12 month visits will be compared to determine if participants in each of the treatment groups had a reduction in pain. Bladder pain ratings at first urge will be used at the outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
353 participants
Primary outcome timeframe
0 (baseline), 6 month, and 12 month visits
Results posted on
2023-06-18
Participant Flow
Patients were drawn from a separate cross-sectional, observational study that included women who mostly had moderate-to-severe dysmenorrhea, but also included some healthy controls, and patients with other chronic pain conditions who served as positive controls for that study. Those with D+COS and PBS in the four intervention arms first participated in the strictly observational study, yielding all baseline data. The Intervention arm participants are NOT included in the "no intervention' arms.
Participant milestones
| Measure |
D+COS-no OC
10 participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
|
D+COS-cyclic Microgestin 1/20
26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
cyclic microgestin 1/20: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
|
D+COS-continuous Microgestin 1/20
26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
PBS-continuous Microgestin 1/20
26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
No Intervention: Healthy Controls
Healthy control cases will have average pain ≤ 3/10 with menses or with withdrawal uterine bleeding from cyclical OCs and b) \< 2 migraines per year will be recruiting preferentially.
|
No Intervention Chronic Pain (Positive Controls)
Chronic Pain (Positive Controls) will have a diagnosed, documented (reviewed by PI) chronic pain disorder greater than six months' duration, which has required at least 2 different prescription treatments and/or surgical management. They must report an average pain of at least 5/10 in the last month. We will accept participants with any type of chronic pain (except for individuals with bilateral knee and hand pain) but anticipate many of our chronic pain participants to suffer from fibromyalgia, lower back pain, and chronic pelvic pain (including irritable bowel syndrome).
|
No Intervention: Dysmenorrhea (D)
Dysmenorrhea cases will have: a) average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) with menses or withdrawal uterine bleeding from cyclic OCs without painkillers, b) menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament and c) indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCs). Dysmenorrhea ONLY cases will have \<16 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Dysmenorrhea With Cross Organ Sensitization (D+COS)
will meet criteria for Dysmenorrhea cases, with \>15 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Painful Bladder Syndrome (PBS)/Interstitial Cystitis (IC)
Diagnosis of PBS participants will be confirmed by medical records indicating chronic (\>3 months) pelvic pain (average intensity ≥ 3/10), pressure, or discomfort related to the bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency.34 PBS participants will also have records review to confirm the exclusion of other conditions by clinical examination or cystoscopy if necessary. PBS participants can have other chronic pain conditions.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
8
|
15
|
45
|
39
|
187
|
35
|
14
|
|
Overall Study
Baseline
|
6
|
4
|
8
|
14
|
37
|
31
|
102
|
34
|
10
|
|
Overall Study
Month 6
|
6
|
4
|
5
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
6
|
4
|
5
|
6
|
37
|
31
|
102
|
34
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
9
|
8
|
8
|
85
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participant did not report a pain rating for first urge during the bladder test.
Baseline characteristics by cohort
| Measure |
D+COS-no OC
n=6 Participants
10 participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
|
D+COS-cyclic Microgestin 1/20
n=4 Participants
26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
cyclic microgestin 1/20: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
|
D+COS-continuous Microgestin 1/20
n=8 Participants
26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
PBS-continuous Microgestin 1/20
n=15 Participants
26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
No Intervention: Healthy Controls
n=37 Participants
Healthy control cases will have average pain ≤ 3/10 with menses or with withdrawal uterine bleeding from cyclical OCs and b) \< 2 migraines per year will be recruited preferentially.
|
No Intervention Chronic Pain (Positive Controls)
n=31 Participants
Chronic Pain (Positive Controls) will have a diagnosed, documented (reviewed by PI) chronic pain disorder greater than six months' duration, which has required at least 2 different prescription treatments and/or surgical management. They must report an average pain of at least 5/10 in the last month. We will accept participants with any type of chronic pain (except for individuals with bilateral knee and hand pain) but anticipate many of our chronic pain participants to suffer from fibromyalgia, lower back pain, and chronic pelvic pain (including irritable bowel syndrome).
|
No Intervention: Dysmenorrhea (D)
n=102 Participants
Dysmenorrhea cases will have: a) average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) with menses or withdrawal uterine bleeding from cyclic OCs without painkillers, b) menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament and c) indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCs). Dysmenorrhea ONLY cases will have \<16 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Dysmenorrhea With Cross Organ Sensitization (D+COS)
n=34 Participants
will meet criteria for Dysmenorrhea cases, with \>15 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Painful Bladder Syndrome (PBS)/Interstitial Cystitis (IC)
n=10 Participants
Diagnosis of PBS participants will be confirmed by medical records indicating chronic (\>3 months) pelvic pain (average intensity ≥ 3/10), pressure, or discomfort related to the bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency.34 PBS participants will also have records review to confirm the exclusion of other conditions by clinical examination or cystoscopy if necessary. PBS participants can have other chronic pain conditions.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
24.7 years
STANDARD_DEVIATION 5.5 • n=6 Participants
|
20.00 years
STANDARD_DEVIATION 1.41 • n=4 Participants
|
22.2 years
STANDARD_DEVIATION 4.06 • n=8 Participants
|
30.4 years
STANDARD_DEVIATION 5.93 • n=15 Participants
|
23.9 years
STANDARD_DEVIATION 7.1 • n=37 Participants
|
27.5 years
STANDARD_DEVIATION 6.2 • n=31 Participants
|
24.1 years
STANDARD_DEVIATION 6.7 • n=102 Participants
|
24.7 years
STANDARD_DEVIATION 6.5 • n=34 Participants
|
26.8 years
STANDARD_DEVIATION 5.5 • n=10 Participants
|
26.1 years
STANDARD_DEVIATION 6.43 • n=247 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=15 Participants
|
37 Participants
n=37 Participants
|
31 Participants
n=31 Participants
|
102 Participants
n=102 Participants
|
34 Participants
n=34 Participants
|
10 Participants
n=10 Participants
|
247 Participants
n=247 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=247 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=37 Participants
|
29 Participants
n=31 Participants
|
15 Participants
n=102 Participants
|
7 Participants
n=34 Participants
|
0 Participants
n=10 Participants
|
55 Participants
n=247 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=15 Participants
|
34 Participants
n=37 Participants
|
2 Participants
n=31 Participants
|
87 Participants
n=102 Participants
|
27 Participants
n=34 Participants
|
10 Participants
n=10 Participants
|
192 Participants
n=247 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=247 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=247 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
9 Participants
n=37 Participants
|
0 Participants
n=31 Participants
|
15 Participants
n=102 Participants
|
7 Participants
n=34 Participants
|
0 Participants
n=10 Participants
|
36 Participants
n=247 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=247 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=37 Participants
|
2 Participants
n=31 Participants
|
21 Participants
n=102 Participants
|
6 Participants
n=34 Participants
|
0 Participants
n=10 Participants
|
38 Participants
n=247 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=15 Participants
|
21 Participants
n=37 Participants
|
28 Participants
n=31 Participants
|
53 Participants
n=102 Participants
|
20 Participants
n=34 Participants
|
8 Participants
n=10 Participants
|
151 Participants
n=247 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=37 Participants
|
1 Participants
n=31 Participants
|
13 Participants
n=102 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=10 Participants
|
20 Participants
n=247 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=247 Participants
|
|
Bladder Pain Sensitivity
|
38.2 Visual Analog Scale
STANDARD_DEVIATION 13.5 • n=6 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
37.0 Visual Analog Scale
STANDARD_DEVIATION 10.7 • n=4 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
41.2 Visual Analog Scale
STANDARD_DEVIATION 16.9 • n=8 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
47.9 Visual Analog Scale
STANDARD_DEVIATION 12.9 • n=14 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
2.2 Visual Analog Scale
STANDARD_DEVIATION 2.8 • n=37 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
17.3 Visual Analog Scale
STANDARD_DEVIATION 17.3 • n=31 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
4.1 Visual Analog Scale
STANDARD_DEVIATION 4.2 • n=102 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
33 Visual Analog Scale
STANDARD_DEVIATION 13.9 • n=33 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
49.0 Visual Analog Scale
STANDARD_DEVIATION 26.4 • n=10 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
43.0 Visual Analog Scale
STANDARD_DEVIATION 14.0 • n=245 Participants • Participant did not report a pain rating for first urge during the bladder test.
|
|
Quantitative Sensory Testing (QST) parameters regarding pelvic hyperalgesia
|
5.95 Newtons
STANDARD_DEVIATION 3.96 • n=5 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
9.38 Newtons
STANDARD_DEVIATION 6.56 • n=4 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
13.8 Newtons
STANDARD_DEVIATION 11.9 • n=8 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
8.21 Newtons
STANDARD_DEVIATION 6.04 • n=14 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
11.6 Newtons
STANDARD_DEVIATION 6.4 • n=37 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
6.9 Newtons
STANDARD_DEVIATION 4.5 • n=31 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
8.9 Newtons
STANDARD_DEVIATION 5.6 • n=102 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
7.2 Newtons
STANDARD_DEVIATION 5.2 • n=34 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
6.9 Newtons
STANDARD_DEVIATION 3.2 • n=10 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
9.43 Newtons
STANDARD_DEVIATION 7.92 • n=245 Participants • Malfunctioning digital algometer or pelvic pain testing was too painful for participants to complete testing.
|
PRIMARY outcome
Timeframe: 0 (baseline), 6 month, and 12 month visitsPopulation: Some participant data were missing due to task error or attrition.
Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the initial, 6 month and 12 month visits will be compared to determine if participants in each of the treatment groups had a reduction in pain. Bladder pain ratings at first urge will be used at the outcome measure.
Outcome measures
| Measure |
D+COS-no OC
n=6 Participants
10 participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
|
D+COS-cyclic Microgestin 1/20
n=4 Participants
26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
cyclic microgestin 1/20: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
|
D+COS-continuous Microgestin 1/20
n=8 Participants
26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
PBS-continuous Microgestin 1/20
n=14 Participants
26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
No Intervention: Healthy Controls
n=37 Participants
Healthy control cases will have average pain ≤ 3/10 with menses or with withdrawal uterine bleeding from cyclical OCs and b) \< 2 migraines per year will be recruiting preferentially.
|
No Intervention Chronic Pain (Positive Controls)
n=31 Participants
Chronic Pain (Positive Controls) will have a diagnosed, documented (reviewed by PI) chronic pain disorder greater than six months' duration, which has required at least 2 different prescription treatments and/or surgical management. They must report an average pain of at least 5/10 in the last month. We will accept participants with any type of chronic pain (except for individuals with bilateral knee and hand pain) but anticipate many of our chronic pain participants to suffer from fibromyalgia, lower back pain, and chronic pelvic pain (including irritable bowel syndrome).
|
No Intervention: Dysmenorrhea (D)
n=102 Participants
Dysmenorrhea cases will have: a) average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) with menses or withdrawal uterine bleeding from cyclic OCs without painkillers, b) menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament and c) indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCs). Dysmenorrhea ONLY cases will have \<16 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Dysmenorrhea With Cross Organ Sensitization (D+COS)
n=33 Participants
will meet criteria for Dysmenorrhea cases, with \>15 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Painful Bladder Syndrome (PBS)/Interstitial Cystitis (IC)
n=10 Participants
Diagnosis of PBS participants will be confirmed by medical records indicating chronic (\>3 months) pelvic pain (average intensity ≥ 3/10), pressure, or discomfort related to the bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency.34 PBS participants will also have records review to confirm the exclusion of other conditions by clinical examination or cystoscopy if necessary. PBS participants can have other chronic pain conditions.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Participant Bladder Pain Sensitivity From Baseline.
Baseline
|
38.2 score on a scale
Standard Deviation 13.5
|
37.0 score on a scale
Standard Deviation 10.7
|
41.2 score on a scale
Standard Deviation 16.9
|
47.9 score on a scale
Standard Deviation 12.9
|
2.2 score on a scale
Standard Deviation 2.8
|
17.3 score on a scale
Standard Deviation 17.3
|
4.1 score on a scale
Standard Deviation 4.2
|
33 score on a scale
Standard Deviation 13.9
|
49.0 score on a scale
Standard Deviation 26.4
|
|
Change in Participant Bladder Pain Sensitivity From Baseline.
Month 6
|
44.5 score on a scale
Standard Deviation 18.5
|
32.0 score on a scale
Standard Deviation 21.2
|
18.6 score on a scale
Standard Deviation 14.7
|
41.4 score on a scale
Standard Deviation 21.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Participant Bladder Pain Sensitivity From Baseline.
Month 12
|
47.0 score on a scale
Standard Deviation 17.3
|
34.0 score on a scale
Standard Deviation 23.5
|
8.6 score on a scale
Standard Deviation 10.0
|
38.8 score on a scale
Standard Deviation 21.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (baseline), 6 months and 12 monthsPopulation: Some participants have missing data due to equipment malfunction or reported pain testing as too painful.
Results from the QST testing performed at initial, 6 month and 12 month visits will be compared to determine if participants in each of the treatment groups had a reduction in sensitivity from baseline. Specifically, measure reported is the pressure pain threshold in newtons observed at the transition from pressure to pain transvaginally at the 12 o'clock position (anteriorly against the bladder). Lower values (pressure) indicate greater sensitivity.
Outcome measures
| Measure |
D+COS-no OC
n=5 Participants
10 participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
|
D+COS-cyclic Microgestin 1/20
n=4 Participants
26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
cyclic microgestin 1/20: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
|
D+COS-continuous Microgestin 1/20
n=8 Participants
26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
PBS-continuous Microgestin 1/20
n=14 Participants
26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
No Intervention: Healthy Controls
n=37 Participants
Healthy control cases will have average pain ≤ 3/10 with menses or with withdrawal uterine bleeding from cyclical OCs and b) \< 2 migraines per year will be recruiting preferentially.
|
No Intervention Chronic Pain (Positive Controls)
n=31 Participants
Chronic Pain (Positive Controls) will have a diagnosed, documented (reviewed by PI) chronic pain disorder greater than six months' duration, which has required at least 2 different prescription treatments and/or surgical management. They must report an average pain of at least 5/10 in the last month. We will accept participants with any type of chronic pain (except for individuals with bilateral knee and hand pain) but anticipate many of our chronic pain participants to suffer from fibromyalgia, lower back pain, and chronic pelvic pain (including irritable bowel syndrome).
|
No Intervention: Dysmenorrhea (D)
n=102 Participants
Dysmenorrhea cases will have: a) average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) with menses or withdrawal uterine bleeding from cyclic OCs without painkillers, b) menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament and c) indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCs). Dysmenorrhea ONLY cases will have \<16 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Dysmenorrhea With Cross Organ Sensitization (D+COS)
n=34 Participants
will meet criteria for Dysmenorrhea cases, with \>15 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Painful Bladder Syndrome (PBS)/Interstitial Cystitis (IC)
n=10 Participants
Diagnosis of PBS participants will be confirmed by medical records indicating chronic (\>3 months) pelvic pain (average intensity ≥ 3/10), pressure, or discomfort related to the bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency.34 PBS participants will also have records review to confirm the exclusion of other conditions by clinical examination or cystoscopy if necessary. PBS participants can have other chronic pain conditions.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Quantitative Sensory Testing (QST) Parameters Regarding Pelvic Hyperalgesia From Baseline
Baseline
|
5.95 Newtons
Standard Deviation 3.96
|
9.38 Newtons
Standard Deviation 6.56
|
13.8 Newtons
Standard Deviation 11.9
|
8.21 Newtons
Standard Deviation 6.04
|
11.6 Newtons
Standard Deviation 6.4
|
6.9 Newtons
Standard Deviation 4.5
|
8.9 Newtons
Standard Deviation 5.6
|
7.2 Newtons
Standard Deviation 5.2
|
6.9 Newtons
Standard Deviation 3.2
|
|
Change in Quantitative Sensory Testing (QST) Parameters Regarding Pelvic Hyperalgesia From Baseline
Month 6
|
5.40 Newtons
Standard Deviation 5.71
|
13.9 Newtons
Standard Deviation 12.9
|
12.3 Newtons
Standard Deviation 10.1
|
3.39 Newtons
Standard Deviation 1.93
|
—
|
—
|
—
|
—
|
—
|
|
Change in Quantitative Sensory Testing (QST) Parameters Regarding Pelvic Hyperalgesia From Baseline
Month 12
|
7.36 Newtons
Standard Deviation 8.67
|
7.74 Newtons
Standard Deviation 6.13
|
9.94 Newtons
Standard Deviation 6.80
|
5.59 Newtons
Standard Deviation 1.85
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: Some participant data were missing due to attrition, or lack of available equipment on day of study
We obtained the peak alpha frequency at the right and left parietal occipital electrodes and averages of the two sides were assessed at Baseline, 6 month, and 12 Month to determine whether differences in resting state brain activity at parieto-occipital electrode sites are affected by oral contraceptives
Outcome measures
| Measure |
D+COS-no OC
n=6 Participants
10 participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
|
D+COS-cyclic Microgestin 1/20
n=4 Participants
26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
cyclic microgestin 1/20: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
|
D+COS-continuous Microgestin 1/20
n=6 Participants
26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
PBS-continuous Microgestin 1/20
n=10 Participants
26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
No Intervention: Healthy Controls
n=31 Participants
Healthy control cases will have average pain ≤ 3/10 with menses or with withdrawal uterine bleeding from cyclical OCs and b) \< 2 migraines per year will be recruiting preferentially.
|
No Intervention Chronic Pain (Positive Controls)
n=31 Participants
Chronic Pain (Positive Controls) will have a diagnosed, documented (reviewed by PI) chronic pain disorder greater than six months' duration, which has required at least 2 different prescription treatments and/or surgical management. They must report an average pain of at least 5/10 in the last month. We will accept participants with any type of chronic pain (except for individuals with bilateral knee and hand pain) but anticipate many of our chronic pain participants to suffer from fibromyalgia, lower back pain, and chronic pelvic pain (including irritable bowel syndrome).
|
No Intervention: Dysmenorrhea (D)
n=92 Participants
Dysmenorrhea cases will have: a) average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) with menses or withdrawal uterine bleeding from cyclic OCs without painkillers, b) menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament and c) indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCs). Dysmenorrhea ONLY cases will have \<16 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Dysmenorrhea With Cross Organ Sensitization (D+COS)
n=29 Participants
will meet criteria for Dysmenorrhea cases, with \>15 bladder pain on a 0-100 visual analogue scale (VAS) during either first sensation or first urge at assessment visit #1.
|
No Intervention: Painful Bladder Syndrome (PBS)/Interstitial Cystitis (IC)
n=10 Participants
Diagnosis of PBS participants will be confirmed by medical records indicating chronic (\>3 months) pelvic pain (average intensity ≥ 3/10), pressure, or discomfort related to the bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency.34 PBS participants will also have records review to confirm the exclusion of other conditions by clinical examination or cystoscopy if necessary. PBS participants can have other chronic pain conditions.
|
|---|---|---|---|---|---|---|---|---|---|
|
Differences in EEG Recorded Cortical Activity Among Participants
Baseline
|
10.03 Hertz
Standard Error 0.26
|
10.0 Hertz
Standard Error 0.59
|
10.05 Hertz
Standard Error 0.07
|
10.13 Hertz
Standard Error 0.08
|
10.03 Hertz
Standard Error 0.06
|
10.15 Hertz
Standard Error 0.07
|
10.12 Hertz
Standard Error 0.04
|
9.96 Hertz
Standard Error 0.06
|
10.0 Hertz
Standard Error 0.07
|
|
Differences in EEG Recorded Cortical Activity Among Participants
Month 6
|
10.10 Hertz
Standard Error 0.24
|
10.01 Hertz
Standard Error 0.1
|
10.19 Hertz
Standard Error 0.26
|
10.16 Hertz
Standard Error 0.18
|
—
|
—
|
—
|
—
|
—
|
|
Differences in EEG Recorded Cortical Activity Among Participants
Month 12
|
9.88 Hertz
Standard Error 0.17
|
9.97 Hertz
Standard Error 0.94
|
9.75 Hertz
Standard Error 0.27
|
10.48 Hertz
Standard Error 0.29
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
D+COS-no OC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D+COS-cyclic Microgestin 1/20
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
D+COS-continuous Microgestin 1/20
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PBS-continuous Microgestin 1/20
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D+COS-no OC
n=5 participants at risk
10 participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
|
D+COS-cyclic Microgestin 1/20
n=4 participants at risk
26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
cyclic microgestin 1/20: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
|
D+COS-continuous Microgestin 1/20
n=8 participants at risk
26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
PBS-continuous Microgestin 1/20
n=6 participants at risk
26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20: Continuous OC use - Pills containing hormones will be taken every day for 1 year
|
|---|---|---|---|---|
|
Eye disorders
Changes in vision
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
75.0%
3/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
37.5%
3/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
16.7%
1/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Skin and subcutaneous tissue disorders
Darkening of the skin or face
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
25.0%
1/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
12.5%
1/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
33.3%
2/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Reproductive system and breast disorders
Decreased sex drive
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
75.0%
3/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
50.0%
4/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
50.0%
3/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Nervous system disorders
Nausea
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
4/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
8/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
6/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
50.0%
2/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
12.5%
1/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
33.3%
2/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Reproductive system and breast disorders
Spotting (between periods)
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
4/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
8/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
6/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
75.0%
3/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
75.0%
6/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
6/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Metabolism and nutrition disorders
Weight Gain
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
4/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
87.5%
7/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
83.3%
5/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Nervous system disorders
Headache
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
4/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
87.5%
7/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
6/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Psychiatric disorders
Depressed, sad a lot
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
4/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
75.0%
6/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
6/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
|
Psychiatric disorders
Irritable
|
—
0/0 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
4/4 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
87.5%
7/8 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
|
100.0%
6/6 • Surveys of adverse events were collected monthly over 1 Year
We used a survey with prespecified questions. Please note, all-cause mortality or serious \& other AEs were not monitored in the "no intervention arms". In the intervention arms, no formal query for mortality or serious AE was done, but we did monitor for them. For nonserious AEs, we report the frequency of ever reporting any queried event over the entire period. Participants varied in total AE form completion. Participants in the "D+COS-no OC" group did not receive AE questionnaires.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place