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Trial record 89 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD) (PMDD)

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ClinicalTrials.gov Identifier: NCT00927095
Recruitment Status : Completed
First Posted : June 24, 2009
Results First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Girdler, PhD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Premenstrual Dysphoric Disorder
Interventions Drug: Continuous OC (EE/DROS)
Drug: Intermittent OC (EE/DROS)
Drug: placebo
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Continuous Low Dose Oral Contraceptive Interrupted Low Dose Oral Contraceptive (21/7 Platform) Continuous Placebo
Hide Arm/Group Description

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)

20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month

continuous placebo

placebo: daily

Period Title: Overall Study
Started 22 21 24
Completed 16 17 22
Not Completed 6 4 2
Reason Not Completed
Adverse Event             3             1             0
Withdrawal by Subject             2             1             1
Physician Decision             1             2             1
Arm/Group Title Continuous Low Dose Oral Contraceptive Interrupted Low Dose Oral Contraceptive (21/7 Platform) Continuous Placebo Total
Hide Arm/Group Description

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)

20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month

continuous placebo

placebo: daily

Total of all reporting groups
Overall Number of Baseline Participants 22 21 24 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 24 participants 67 participants
33.2  (8.1) 32.2  (8.6) 32.1  (6.7) 32.5  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 24 participants 67 participants
Female
22
 100.0%
21
 100.0%
24
 100.0%
67
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 21 participants 24 participants 67 participants
22 21 24 67
1.Primary Outcome
Title Pre-Post Change in Premenstrual Symptom Severity
Hide Description 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.
Time Frame monthly
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Low Dose Oral Contraceptive Interrupted Low Dose Oral Contraceptive (21/7 Platform) Continuous Placebo
Hide Arm/Group Description:

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)

20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month

continuous placebo

placebo: daily

Overall Number of Participants Analyzed 16 17 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.93  (.22) 1.73  (.22) 1.64  (.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuous Low Dose Oral Contraceptive Interrupted Low Dose Oral Contraceptive (21/7 Platform) Continuous Placebo
Hide Arm/Group Description

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)

20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month

continuous placebo

placebo: daily

All-Cause Mortality
Continuous Low Dose Oral Contraceptive Interrupted Low Dose Oral Contraceptive (21/7 Platform) Continuous Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Continuous Low Dose Oral Contraceptive Interrupted Low Dose Oral Contraceptive (21/7 Platform) Continuous Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/21 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Low Dose Oral Contraceptive Interrupted Low Dose Oral Contraceptive (21/7 Platform) Continuous Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/22 (100.00%)      21/21 (100.00%)      24/24 (100.00%)    
Gastrointestinal disorders       
GI Symptoms   13/22 (59.09%)  13 16/21 (76.19%)  16 13/24 (54.17%)  13
Bloating   4/22 (18.18%)  4 11/21 (52.38%)  11 10/24 (41.67%)  10
Heartburn or Reflux   0/22 (0.00%)  0 1/21 (4.76%)  1 0/24 (0.00%)  0
General disorders       
Fatigue   14/22 (63.64%)  14 17/21 (80.95%)  17 15/24 (62.50%)  15
Infections and infestations       
Yeast Infection   2/22 (9.09%)  2 1/21 (4.76%)  1 2/24 (8.33%)  2
Musculoskeletal and connective tissue disorders       
Leg or Calf Discomfort   10/22 (45.45%)  10 13/21 (61.90%)  13 9/24 (37.50%)  9
Nervous system disorders       
Headache, Not Migraine   10/22 (45.45%)  10 16/21 (76.19%)  16 20/24 (83.33%)  20
Headache, Migraine, No Aura   5/22 (22.73%)  5 3/21 (14.29%)  3 3/24 (12.50%)  3
Headache, Migraine, with Aura   0/22 (0.00%)  0 1/21 (4.76%)  1 0/24 (0.00%)  0
Psychiatric disorders       
Low Mood   17/22 (77.27%)  17 13/21 (61.90%)  13 17/24 (70.83%)  17
Irritability   14/22 (63.64%)  14 14/21 (66.67%)  14 15/24 (62.50%)  15
Anxious Symptoms   8/22 (36.36%)  8 8/21 (38.10%)  8 15/24 (62.50%)  15
Suicidality   4/22 (18.18%)  4 2/21 (9.52%)  2 1/24 (4.17%)  1
Reproductive system and breast disorders       
Breast Tenderness   15/22 (68.18%)  15 15/21 (71.43%)  15 18/24 (75.00%)  18
Spotting   11/22 (50.00%)  11 10/21 (47.62%)  10 4/24 (16.67%)  4
Changing Bleeding Pattern - Prolonged Bleeding   7/22 (31.82%)  7 4/21 (19.05%)  4 2/24 (8.33%)  2
Change in Bleeding Pattern   2/22 (9.09%)  2 2/21 (9.52%)  2 3/24 (12.50%)  3
Respiratory, thoracic and mediastinal disorders       
Shortness of Breath or Chest Pain   3/22 (13.64%)  3 3/21 (14.29%)  3 2/24 (8.33%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Susan Girdler
Organization: University of North Carolina at Chapel Hill
Phone: 919-966-2179
Responsible Party: Susan Girdler, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00927095     History of Changes
Other Study ID Numbers: MH081837
R01MH081837 ( U.S. NIH Grant/Contract )
First Submitted: June 22, 2009
First Posted: June 24, 2009
Results First Submitted: April 25, 2016
Results First Posted: August 24, 2016
Last Update Posted: August 24, 2016