Trial Outcomes & Findings for Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD) (NCT NCT00927095)
NCT ID: NCT00927095
Last Updated: 2016-08-24
Results Overview
Pre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal, 3=Mild, 4=Moderate, 5=Severe, 6=Extreme. The change variable presented here is calculated as follows: "mean rating on the individual's worst symptom during the premenstrual week at baseline" minus "mean rating during the premenstrual week during the last on-treatment cycle". Therefore, higher values on this outcome variable correspond to greater reductions in premenstrual symptoms across the trial.
COMPLETED
PHASE4
67 participants
monthly
2016-08-24
Participant Flow
Participant milestones
| Measure |
Continuous Low Dose Oral Contraceptive
continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months
|
Interrupted Low Dose Oral Contraceptive (21/7 Platform)
interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month
|
Continuous Placebo
continuous placebo
placebo: daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
24
|
|
Overall Study
COMPLETED
|
16
|
17
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
2
|
Reasons for withdrawal
| Measure |
Continuous Low Dose Oral Contraceptive
continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months
|
Interrupted Low Dose Oral Contraceptive (21/7 Platform)
interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month
|
Continuous Placebo
continuous placebo
placebo: daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
1
|
Baseline Characteristics
Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)
Baseline characteristics by cohort
| Measure |
Continuous Low Dose Oral Contraceptive
n=22 Participants
continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months
|
Interrupted Low Dose Oral Contraceptive (21/7 Platform)
n=21 Participants
interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month
|
Continuous Placebo
n=24 Participants
continuous placebo
placebo: daily
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 8.1 • n=93 Participants
|
32.2 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
32.1 years
STANDARD_DEVIATION 6.7 • n=27 Participants
|
32.5 years
STANDARD_DEVIATION 7.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
67 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
|
22 participants
n=93 Participants
|
21 participants
n=4 Participants
|
24 participants
n=27 Participants
|
67 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: monthlyPre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal, 3=Mild, 4=Moderate, 5=Severe, 6=Extreme. The change variable presented here is calculated as follows: "mean rating on the individual's worst symptom during the premenstrual week at baseline" minus "mean rating during the premenstrual week during the last on-treatment cycle". Therefore, higher values on this outcome variable correspond to greater reductions in premenstrual symptoms across the trial.
Outcome measures
| Measure |
Continuous Low Dose Oral Contraceptive
n=16 Participants
continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months
|
Interrupted Low Dose Oral Contraceptive (21/7 Platform)
n=17 Participants
interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month
|
Continuous Placebo
n=21 Participants
continuous placebo
placebo: daily
|
|---|---|---|---|
|
Pre-Post Change in Premenstrual Symptom Severity
|
1.93 units on a scale
Standard Deviation .22
|
1.73 units on a scale
Standard Deviation .22
|
1.64 units on a scale
Standard Deviation .19
|
Adverse Events
Continuous Low Dose Oral Contraceptive
Interrupted Low Dose Oral Contraceptive (21/7 Platform)
Continuous Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous Low Dose Oral Contraceptive
n=22 participants at risk
continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months
|
Interrupted Low Dose Oral Contraceptive (21/7 Platform)
n=21 participants at risk
interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month
|
Continuous Placebo
n=24 participants at risk
continuous placebo
placebo: daily
|
|---|---|---|---|
|
Reproductive system and breast disorders
Breast Tenderness
|
68.2%
15/22 • Number of events 15
|
71.4%
15/21 • Number of events 15
|
75.0%
18/24 • Number of events 18
|
|
Psychiatric disorders
Low Mood
|
77.3%
17/22 • Number of events 17
|
61.9%
13/21 • Number of events 13
|
70.8%
17/24 • Number of events 17
|
|
Nervous system disorders
Headache, Not Migraine
|
45.5%
10/22 • Number of events 10
|
76.2%
16/21 • Number of events 16
|
83.3%
20/24 • Number of events 20
|
|
General disorders
Fatigue
|
63.6%
14/22 • Number of events 14
|
81.0%
17/21 • Number of events 17
|
62.5%
15/24 • Number of events 15
|
|
Psychiatric disorders
Irritability
|
63.6%
14/22 • Number of events 14
|
66.7%
14/21 • Number of events 14
|
62.5%
15/24 • Number of events 15
|
|
Gastrointestinal disorders
GI Symptoms
|
59.1%
13/22 • Number of events 13
|
76.2%
16/21 • Number of events 16
|
54.2%
13/24 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Leg or Calf Discomfort
|
45.5%
10/22 • Number of events 10
|
61.9%
13/21 • Number of events 13
|
37.5%
9/24 • Number of events 9
|
|
Psychiatric disorders
Anxious Symptoms
|
36.4%
8/22 • Number of events 8
|
38.1%
8/21 • Number of events 8
|
62.5%
15/24 • Number of events 15
|
|
Gastrointestinal disorders
Bloating
|
18.2%
4/22 • Number of events 4
|
52.4%
11/21 • Number of events 11
|
41.7%
10/24 • Number of events 10
|
|
Reproductive system and breast disorders
Spotting
|
50.0%
11/22 • Number of events 11
|
47.6%
10/21 • Number of events 10
|
16.7%
4/24 • Number of events 4
|
|
Reproductive system and breast disorders
Changing Bleeding Pattern - Prolonged Bleeding
|
31.8%
7/22 • Number of events 7
|
19.0%
4/21 • Number of events 4
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Headache, Migraine, No Aura
|
22.7%
5/22 • Number of events 5
|
14.3%
3/21 • Number of events 3
|
12.5%
3/24 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath or Chest Pain
|
13.6%
3/22 • Number of events 3
|
14.3%
3/21 • Number of events 3
|
8.3%
2/24 • Number of events 2
|
|
Reproductive system and breast disorders
Change in Bleeding Pattern
|
9.1%
2/22 • Number of events 2
|
9.5%
2/21 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
|
Psychiatric disorders
Suicidality
|
18.2%
4/22 • Number of events 4
|
9.5%
2/21 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Yeast Infection
|
9.1%
2/22 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn or Reflux
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Headache, Migraine, with Aura
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
0.00%
0/24
|
Additional Information
Dr. Susan Girdler
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place